South African National Clinical Trials Registry
South African Medical Research Council, Cochrane South Africa
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: sactradmin@mrc.ac.za Website: sanctr.samrc.ac.za
Trial no.: DOH-27-0117-5309 Date of Approval:
Trial Status: Approved
TRIAL DESCRIPTION
Public title TB CHAMP: Tuberculosis Child Multidrug-resistant Preventive Therapy Trial
Official scientific title A phase III cluster randomised placebo-controlled trial to assess the efficacy of preventive therapy in child and adolescent contacts of multidrug-resistant (MDR) tuberculosis (TB).
Brief summary describing the background and objectives of the trial The World Health Organisation (WHO) estimates that there were half a million multidrug-resistant tuberculosis (MDR-TB)cases in the world in 2013. Conservative assessments suggest that in areas with a high number of TB cases, there are at least two children in direct household contact with an adult with TB, putting them at high risk of developing the disease. The treatment of MDR-TB in children is complex, expensive, long, associated with frequent and significant side effects, and frequently requires long stays in hospital. Prevention of MDR-TB in children is therefore very important. Although the need for a research study to assess potential preventive therapies (treatments) for children in contact with MDR-TB patients was identified in 1992, there haven’t been any done yet. Therefore the WHO cannot recommend any specific drug treatments for people who are in contact with others in the same household that have infectious MDR-TB. While infection with normal (non-drug resistant) TB bacteria can be prevented by using a drug called isoniazid taken daily for six months, MDR-TB bacteria are resistant to isoniazid. However, there is the possibility that these MDR-TB bacteria can potentially be treated with another drug called levofloxacin, which is also taken daily for six months. Levofloxacin is approved by the United States Food and Drug Administration (FDA) and the South African Health Products Regulatory Authority (SAHPRA) for treating MDR-TB in adults. It is also routinely used for the treatment of MDR-TB in young children. Levofloxacin is not approved for the prevention of MDR-TB. No rigorous research has yet been done to specifically study this in children, hence the need for this study. TB
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TB CHAMP
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Prevention
Anticipated trial start date 01/04/2016
Actual trial start date 08/12/2016
Anticipated date of last follow up 21/01/2023
Actual Last follow-up date 31/01/2023
Anticipated target sample size (number of participants) 1009
Actual target sample size (number of participants) 922
Recruitment status Completed
Publication URL Manuscript under external final review
Secondary Ids Issuing authority/Trial register
TB CHAMP TB CHAMP
20160128 South African Health Products Regulatory Authority
M16/02/009 Stellenbosch University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Levofloxacin 25mg/kg maximum 750mg 24 weeks placebo 505 Uncontrolled
Experimental Group Levofloxacin 25mg/kg maximum 750mg daily dosing 24 weeks Active treatment for prevention 505
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. HIV-infected and -uninfected child and adolescents (0-17 years) household contacts of adult MDR-TB index cases 2. Primary residence in the household of the adult MDR-TB index case 3. Consent from parent or legal guardian for the child/adolescent for HIV testing 4. Consent obtained from parent/legal guardian for child/adolescent to be enrolled 5. Assent obtained from any child/adolescent 7 years or older 5. If older than 5 and younger than 18 years the child/adolescent must have a positive IGRA test before enrollment unless HIV positive 1. TB disease at enrolment 2. Currently on INH or a FQN (e.g. LFX, MFX, ofloxacin or ciprofloxacin) for =14 days 3. Treated for TB in the previous 12 months 4. Known concurrent exposure to an INH-susceptible (including RIF-monoresistant) index case 5. Weight below 3.0 kg 6. Positive pregnancy test at enrollment 7. 6 months or less post-partum Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 0 Month(s) 17 Year(s) Both
APPROVALS
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/05/2016 Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Victoria St and Ryneveld Street Cape Town 7005 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/12/2016 SAHPRA
Ethics Committee Address
Street address City Postal code Country
CSIR Reception Building 38a Meiring Naudé Road Brummeria Pretoria Pretoria 0001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incident TB disease ( confirmed or unconfirmed) including TB death, by 48 weeks post-randomisation 48 weeks post randomisation
Secondary Outcome 1. TB disease by 72 weeks 2. All-cause mortality by 48 and 72 weeks 3. Adverse events grade 3 or more that are possibly associated to study drug 4. Adverse events grade 3 or more from starting treatment to 30 days after last study drug dose 5. Serious adverse event up to 30 days after last drug dose 6. Discontinuation of study treatment due to AEs of any grade 48 and 72 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Province Country
Desmond Tutu TB Centre Franzie Van Zijl Drive Cape Town South Africa
Shandukani Research Centre Esselen and Klein Street, Hill brow Johannesburg South Africa
Matlosana Perinatal HIV Research Centre P.O box 114 Diepkloof Sowetu Johannesburg South Africa
Isango Lethemba TB Research Centre Mission Road Port Elizabeth South Africa South Africa
THINK 6 Lucas Drive Hill crest Kwazulu Natal South Africa
FUNDING SOURCES
Name of source Street address City Province Country
UnitAid Benefit Kids Joint Global Health Trials Scheme Wellcome Trust and MRC Franzie Van Zijl Drive Cape town South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University South African Franzie Van Zijl, Drive, Faculty of Medicine and Health Sciences, Stellenbosch University Cape Town 8000 South Africa Funding Agency
Secondary Sponsor South African MRC Francie Van Zijl Drive Cape Town 8000 South Africa Funding Agency
COLLABORATORS
Name Street address City Province Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anneke Hesseling annekeh@sun.ac.za 27219389062 Franzie Van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Academic Investigator
Role Name Email Phone Street address
Public Enquiries Susan Purchase purchase@sun.ac.za 0839494939 Franzie Van Zijl Drive,
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Sub investigator
Role Name Email Phone Street address
Scientific Enquiries Anneke Hesseling Annekeh@sun.ac.za 0823001149 Franzie Van Zijl Drive,
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Academic Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes please update Informed Consent Form,Statistical Analysis Plan,Study Protocol pending pending
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Pending No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 01/12/2022 Updated scientific title A phase III cluster randomised placebo-controlled trial to assess the efficacy of preventive therapy in child contacts of multidrug-resistant (MDR) tuberculosis (TB). A phase III cluster randomised placebo-controlled trial to assess the efficacy of preventive therapy in child and adolescent contacts of multidrug-resistant (MDR) tuberculosis (TB).
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 01/12/2022 SANCTR admin please update
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 01/12/2022 Added summary please update The World Health Organisation (WHO) estimates that there were half a million multidrug-resistant tuberculosis (MDR-TB)cases in the world in 2013. Conservative assessments suggest that in areas with a high number of TB cases, there are at least two children in direct household contact with an adult with TB, putting them at high risk of developing the disease. The treatment of MDR-TB in children is complex, expensive, long, associated with frequent and significant side effects, and frequently requires long stays in hospital. Prevention of MDR-TB in children is therefore very important. Although the need for a research study to assess potential preventive therapies (treatments) for children in contact with MDR-TB patients was identified in 1992, there haven’t been any done yet. Therefore the WHO cannot recommend any specific drug treatments for people who are in contact with others in the same household that have infectious MDR-TB. While infection with normal (non-drug resistant) TB bacteria can be prevented by using a drug called isoniazid taken daily for six months, MDR-TB bacteria are resistant to isoniazid. However, there is the possibility that these MDR-TB bacteria can potentially be treated with another drug called levofloxacin, which is also taken daily for six months. Levofloxacin is approved by the United States Food and Drug Administration (FDA) and the South African Health Products Regulatory Authority (SAHPRA) for treating MDR-TB in adults. It is also routinely used for the treatment of MDR-TB in young children. Levofloxacin is not approved for the prevention of MDR-TB. No rigorous research has yet been done to specifically study this in children, hence the need for this study. TB
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Acronym 01/12/2022 Added acronym TB CHAMP
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 01/12/2022 Added Prevention Treatment: Drugs Prevention
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 01/12/2022 Updated start date 08 Dec 2016
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 01/12/2022 SANCTR admin 01 Jan 0001 01 Apr 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 01/12/2022 Last follow up date added 01 Apr 2018 31 Jan 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 01/12/2022 updated end of follow up dated 31 Jan 2023 20 Jan 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 06/06/2024 update 20 Jan 2023 21 Jan 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 01/12/2022 Updated start and end dates 01 Apr 2018 30 Sep 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 01/12/2022 updated end of follow up date 30 Sep 2023 30 Jan 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 06/06/2024 updated 30 Jan 2023 31 Jan 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 01/12/2022 Number of participants added 0 1009
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 01/12/2022 updated total of participants 0 922
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 01/12/2022 Study in follow up only Not yet recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/06/2023 Recruitment and Follow completed. Ongoing for analysis Closed to recruitment,follow-up continuing Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/06/2024 Updated Active, not recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 01/12/2022 Publications pending Pending
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 06/06/2024 publication pending Pending Manuscript under external final review
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 01/12/2022 Updated randomization sequence Simple randomization using a randomization table created by a computer software program
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 01/12/2022 Updated allocation of sequence Allocation was determined by the holder of the sequence who is situated off site
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 01/12/2022 Updated inclusion criteria HIV-infected and -uninfected child (< 5 years) household contacts of adult MDR-TB index cases 1. HIV-infected and -uninfected child and adolescents (0-17 years) household contacts of adult MDR-TB index cases 2. Primary residence in the household of the adult MDR-TB index case 3. Consent from parent or legal guardian for the child/adolescent for HIV testing 4. Consent obtained from parent/legal guardian for child/adolescent to be enrolled 5. Assent obtained from any child/adolescent 7 years or older 5. If older than 5 and younger than 18 years the child/adolescent must have a positive IGRA test before enrollment unless HIV positive
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 01/12/2022 Updated exclusion criteria 1. TB disease at enrolment 2. Currently on INH or a FQN (e.g. LFX, MFX, ofloxacin or ciprofloxacin) for =14 days 3. Treated for TB in the previous 12 months 4. Known concurrent exposure to an INH-susceptible (including RIF-monoresistant) index case 5. Children with myasthenia gravis or Guillain-Barré syndrome 1. TB disease at enrolment 2. Currently on INH or a FQN (e.g. LFX, MFX, ofloxacin or ciprofloxacin) for =14 days 3. Treated for TB in the previous 12 months 4. Known concurrent exposure to an INH-susceptible (including RIF-monoresistant) index case 5. Weight below 3.0 kg 6. Positive pregnancy test at enrollment 7. 6 months or less post-partum
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/12/2022 updated age group Infant: 0 Month-23 Month Infant: 0 Month-23 Month, Adolescent: 13 Year-18 Year
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/12/2022 Updated age Infant: 0 Month-23 Month, Adolescent: 13 Year-18 Year Infant: 0 Month-23 Month
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/12/2022 Updated ages Infant: 0 Month-23 Month Infant: 0 Month-23 Month, Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 01/12/2022 Updated diseases Respiratory, Paediatrics
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Sub disease(s) 01/12/2022 SANCTR admin Tuberculosis
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Sub disease(s) 01/12/2022 Updated diseases Tuberculosis HIV/AIDS, Tuberculosis
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 02/12/2022 Updated identifier TB CHAMP, TB CHAMP, 4309 TB CHAMP, TB CHAMP, 4787
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 01/12/2022 Added Protocol number 20160128, Medicine Control Council, 4309 20160128, South African Health Products Regulatory Authority, 4787
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 01/12/2022 Updated protocol number M16/02/009, Stellenbosch University, 4309 M16/02/009, Stellenbosch University, 4787
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Updated group size Experimental Group, Levofloxacin , , 24 Months, 4309, 778, Placebo Experimental Group, Levofloxacin , 25mg/kg maximum 750mg, 24 Months, 4309, 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Updated experimental group Experimental Group, Levofloxacin , 25mg/kg maximum 750mg, 24 Months, 4309, 505, Placebo Experimental Group, Levofloxacin , 25mg/kg maximum 750mg, 24 weeks, 4309, 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Update experimental group Experimental Group, Levofloxacin , 25mg/kg maximum 750mg, 24 weeks, 4309, 505, Placebo Experimental Group, Levofloxacin , 25mg/kg maximum 750mg, 24 weeks, experimental , 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 updated intervention Experimental Group, Levofloxacin , 25mg/kg maximum 750mg, 24 weeks, experimental , 505, Placebo Experimental Group, Levofloxacin , 25mg/kg maximum 750mg daily dosing, 24 weeks, Prevention, 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Updated intervention Experimental Group, Levofloxacin , 25mg/kg maximum 750mg daily dosing, 24 weeks, Prevention, 505, Placebo Experimental Group, Levofloxacin , 25mg/kg maximum 750mg daily dosing, 24 weeks, Active treatment for prevention, 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 SANCTR update Experimental Group, Levofloxacin , 25mg/kg maximum 750mg daily dosing, 24 weeks, Active treatment for prevention, 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 SANCTR admin Control Group, Please update, please update, please update, please update, 0, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Updated control group Control Group, Please update, please update, please update, please update, 0, Uncontrolled Control Group, Levofloxacin, please update25mg/kg maximum 750mg, 24 weeks , Levoflaxacin, 0, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Updated control group Control Group, Levofloxacin, please update25mg/kg maximum 750mg, 24 weeks , Levoflaxacin, 0, Placebo Control Group, Levofloxacin, 25mg/kg maximum 750mg, 24 weeks , 4309, 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Updated control Control Group, Levofloxacin, 25mg/kg maximum 750mg, 24 weeks , 4309, 505, Placebo Control Group, Levofloxacin, 25mg/kg maximum 750mg, 24 weeks , prevention, 505, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 Updated control Control Group, Levofloxacin, 25mg/kg maximum 750mg, 24 weeks , prevention, 505, Placebo Control Group, Levofloxacin, 25mg/kg maximum 750mg, 24 weeks , prevention, 505, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/12/2022 Updated intervention description Control Group, Levofloxacin, 25mg/kg maximum 750mg, 24 weeks , prevention, 505, Uncontrolled Control Group, Levofloxacin, 25mg/kg maximum 750mg, 24 weeks , placebo, 505, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/12/2022 SANCTR admin Experimental Group, Levofloxacin, 25mg/kg maximum 750mg daily dosing, 24 weeks, Active treatment for prevention, 505,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/12/2022 updated primary outcome Primary Outcome, Incident TB disease (probable or confirmed) including TB death, by 48 weeks post-randomisation, 4309 Primary Outcome, Incident TB disease ( confirmed or unconfirmed) including TB death, by 48 weeks post-randomisation, 48 weeks post randomisation
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/12/2022 Updated secondary outcomes Secondary Outcome, 1. Mortality (all cause, non-traumatic, and TB related) 2. Adverse events = grade 3 (at least possibly associated) during 24 weeks of treatment 3. Percentage of levofloxacin or levofloxacin-placebo doses ingested and retained over 24 weeks 4. TB disease over 96 weeks 5. Incidence of levofloxacin resistant TB disease , 4309 Secondary Outcome, 1. TB disease by 72 weeks 2. All-cause mortality by 48 and 72 weeks 3. Adverse events grade 3 or more that are possibly associated to study drug 4. Adverse events grade 3 or more from starting treatment to 30 days after last study drug dose 5. Serious adverse event up to 30 days after last drug dose 6. Discontinuation of study treatment due to AEs of any grade, 4309
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 02/12/2022 Updated time points Secondary Outcome, 1. TB disease by 72 weeks 2. All-cause mortality by 48 and 72 weeks 3. Adverse events grade 3 or more that are possibly associated to study drug 4. Adverse events grade 3 or more from starting treatment to 30 days after last study drug dose 5. Serious adverse event up to 30 days after last drug dose 6. Discontinuation of study treatment due to AEs of any grade, 4309 Secondary Outcome, 1. TB disease by 72 weeks 2. All-cause mortality by 48 and 72 weeks 3. Adverse events grade 3 or more that are possibly associated to study drug 4. Adverse events grade 3 or more from starting treatment to 30 days after last study drug dose 5. Serious adverse event up to 30 days after last drug dose 6. Discontinuation of study treatment due to AEs of any grade, 48 and 72 weeks
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 Updated address DTTC-SU THINK PHRU WRHI, 4309, Update record, , South Africa Desmond Tutu TB Centre, Franzie Van Zijl Drive, Cape Town, 8000, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 Updated address DTTC - Stellenbosch University Department of Paediatrics and Child Health Faculty of Medicine & Health Sciences Stellenbosch University South Africa, 4309, Update record, , South Africa Shandukani Research Centre, Esselen and Klein Street, , Hill brow Johannesburg, 20012, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 SANCTR admin please update, please update, please update, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 Added recruitment centre please update, please update, please update, , South Africa Matlosana Perinatal HIV Research Centre, P.O box 114 Diepkloof, Sowetu Johannesburg, 1864, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 SANCTR admin please update, please update, please update, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 Added recruitment centre please update, please update, please update, , South Africa Isango Lethemba TB Research Centre, Mission Road, Port Elizabeth South Africa, 6200, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 SANCTR admin please update, please update, please update, , South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 01/12/2022 Added recruitment centre please update, please update, please update, , South Africa THINK, 6 Lucas Drive, Hill crest Kwazulu Natal, 3610, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/12/2022 SANCTR admin True, Stellenbosch University, Update record, Update record, Update record, South Africa, , 13 May 2016, 011 467 3793, support@grenville.co.za, 4309, M16/02/009 True, Stellenbosch University, Victoria St and Ryneveld Street, Cape Town, 7005, South Africa, , 13 May 2016, 0114673793, support@grenville.co.za, 4229_6648_4737.pdf, M16/02/009
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/12/2022 SANCTR update
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/12/2022 SANCTR Update
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/12/2022 SANCTR admin True, SAHPRA, CSIR Reception Building 38a Meiring Naudé Road Brummeria Pretoria, Pretoria, 0001, South Africa, , 08 Dec 2016, 0125010300, enquiries@sahpra.org.za, 4229_13553_4737.pdf, please update
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/12/2022 SANCTR admin True, SAHPRA, CSIR Reception Building 38a Meiring Naudé Road Brummeria Pretoria, Pretoria, 0001, South Africa, , 08 Dec 2016, 0125010300, enquiries@sahpra.org.za, 4229_13553_4737.pdf, please update True, SAHPRA, CSIR Reception Building 38a Meiring Naudé Road Brummeria Pretoria, Pretoria, 0001, South Africa, , 08 Dec 2016, 0125010300, enquiries@sahpra.org.za, 4229_13553_4737.pdf, 20160128
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 01/12/2022 Update funder Update record, 4309, Update record, , South Africa, Funding Agency, , 2.2 million, Primary Funder UnitAid Benefit Kids Joint Global Health Trials Scheme Wellcome Trust and MRC , Franzie Van Zijl Drive, Cape town, 8000, South Africa, Funding Agency, , 2.2 million, Primary Funder
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 01/12/2022 Updated Funding Stellenbosch University, South Africa, 4309, Update record, , South Africa, Primary Sponsor, Funding Agency, Stellenbosch University South African , 4309, Cape Town, 8000, South Africa, Primary Sponsor, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 02/12/2022 Updated street address Stellenbosch University South African , 4309, Cape Town, 8000, South Africa, Primary Sponsor, Funding Agency, Stellenbosch University South African , Franzie Van Zijl, Drive, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, 8000, South Africa, Primary Sponsor, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 01/12/2022 Updated details Sponsor: Stellenbosch University, South Africa Funder: Joint Global Health Trials Scheme of the Department for International Development, UK (DFID), the Wellcome Trust and the Medical Research Council (MRC UK); South African MRC, 4309, Update record, , South Africa, Secondary Sponsor, Funding Agency, South African MRC, Francie Van Zijl Drive, Cape Town , 8000, South Africa, Secondary Sponsor, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 01/12/2022 Updated Principal Investigator, Frieda, Verheye-Dua, Dr., Frieda@sun.ac.za, 4309, 021 938 9772, Department of Paediatrics and Child Health Faculty of Medicine & Health Sciences Stellenbosch University South Africa, Update record, , South Africa, Academic Investigator Principal Investigator, Frieda, Verheye Dua, Dr., Frieda@sun.ac.za, Aminaa@sun.ac.za, 0822950790, Franzie Van Zijl Drive, Cape Town, 8000, South Africa, Academic Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/12/2022 Updated contact details Principal Investigator, Frieda, Verheye Dua, Dr., Frieda@sun.ac.za, Aminaa@sun.ac.za, 0822950790, Franzie Van Zijl Drive, Cape Town, 8000, South Africa, Academic Investigator Principal Investigator, Anneke , Hesseling, Prof., annekeh@sun.ac.za, , 27219389062, Franzie Van Zijl Drive, Cape Town, 8000, South Africa, Academic Investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/12/2022 Updated contact details Public Enquiries, Anneke, Hesseling, Prof., Frieda@sun.ac.za, 4309, 021 938 9772, Department of Paediatrics and Child Health Faculty of Medicine & Health Sciences Stellenbosch University South Africa, Update record, , South Africa, Academic Investigator Public Enquiries, Frieda, Verheye Dua, Dr., Frieda@sun.ac.za, , 0822950790, Franzie Van Zijl Drive, , Cape Town, 8000, South Africa, CRS Co ordinator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 05/06/2023 Update of personnel Public Enquiries, Frieda, Verheye Dua, Dr., Frieda@sun.ac.za, , 0822950790, Franzie Van Zijl Drive, , Cape Town, 8000, South Africa, CRS Co ordinator Public Enquiries, Elize, Batist, Ms., ebatist@sun.ac.za, , 0823799909, Franzie Van Zijl Drive, , Cape Town, 8000, South Africa, Study Co ordinator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 06/06/2024 Update Public Enquiries, Elize, Batist, Ms., ebatist@sun.ac.za, , 0823799909, Franzie Van Zijl Drive, , Cape Town, 8000, South Africa, Study Co ordinator Public Enquiries, Susan, Purchase, Dr., purchase@sun.ac.za, , 0839494939, Franzie Van Zijl Drive, , Cape Town, 8000, South Africa, Sub investigator
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/12/2022 Updated contact details Scientific Enquiries, Anneke, Hesseling, Prof., Frieda@sun.ac.za, 4309, 021 938 9772, Department of Paediatrics and Child Health Faculty of Medicine & Health Sciences Stellenbosch University South Africa, Update record, , South Africa, Academic Investigator Scientific Enquiries, Anneke, Hesseling, Prof., Annekeh@sun.ac.za, , 0823001149, Franzie Van Zijl Drive, , Cape Town, 8000, South Africa, Academic Investigator
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 01/12/2022 SANCTR admin please update
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 01/12/2022 SANCTR admin please update
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 01/12/2022 Updated to pending please update pending
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 01/12/2022 SANCTR admin please update
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 01/12/2022 Updated to pending please update pending
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 01/12/2022 Updated to pending Pending
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 01/12/2022 SANCTR admin Study Protocol
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 02/12/2022 updated Study Protocol Study Protocol, Statistical Analysis Plan, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 01/12/2022 SANCTR admin 0 4752 0 Month(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 01/12/2022 SANCTR admin 5 4752 5 Month(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 01/12/2022 Updated age of adolescent 5 Month(s) 17 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information SAHPRA_APPROVAL_REQUIRED 01/12/2022 SANCTR admin Yes
Section Name Field Name Date Reason Old Value Updated Value
Trial Information COMPLETION_STATUS 01/12/2022 SANCTR admin Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information COMPLETION_STATUS 01/12/2022 Status ongoing Completed In Progress
Section Name Field Name Date Reason Old Value Updated Value
Trial Information COMPLETION_STATUS 06/06/2024 completion In Progress Completed