Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607878828981 Date of Registration: 06/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title CAP 098 (BV Study)
Official scientific title Effects of Bacterial Vaginosis Treatment on the Vaginal Microbiota and Correlates of Treatment Failure (BV Study)
Brief summary describing the background and objectives of the trial Treatment regimens for Bacterial vaginosis (BV) include metronidazole (MDZ) or clindamycin, administered either orally or as vaginal creams, respectively. However, antibiotic treatment of BV is often ineffective, and recurrence rates after treatment are high. It is thought that MDZ resistance and the presence of a thick, structured, and multi-species biofilm layer produced by Gadnerella vaginalis are some of the factors associated with refractory and recurrent BV. Nevertheless, knowledge gaps remain about the exact mechanisms on how G. vaginalis dominated communities contribute to BV recurrence and persistence after antibiotic treatment. In this study, we intend to follow a cohort of women, and evaluate the biologic effects of MDZ treatment on vaginal microbiota in women with BV. In addition, we will employ multiple omics readouts to determine if anaerobes, and specifically different Gardnerella strains, have different expression patterns and immune interactions, which could contribute to persistence, lack of clearance or recurrence of BV. Furthermore, in the laboratory, we plan to assess the lytic effects of the investigational drug candidate, BNT331, an endolysin, which has previously been shown to effectively target G. vaginalis strains. OBJECTIVES: • To evaluate the impact of a standard course of oral MDZ treatment (400 mg twice per day for 7 days) on the vaginal microbiota of South African women with BV • To characterize the level of resistance of the vaginal microbiota with high G. vaginalis relative abundance before and after BV treatment with MDZ • To assess the proportion of women with recurrent or persistent BV on Day 8, 16 and 24 follow-up visits. • To assess whether MDZ and clindamycin treatment levels correlate with BV-linked microbiota resistance in vivo. • To characterise re-emerging Lactobacillus species after culturing with MDZ treatment and endolysin BNT331. • To assess the in vitro efficacy of the endolysin BNT331 against Gardnerella strains and other bacterial species found within the persistent or recurrent polymicrobial outgrowth of anaerobic microbiota using the human Vagina Chip and eVOLVER models. • To establish a biobank of diverse vaginal microbiota strains isolated from samples both before and after MDZ treatment. • To evaluate new STI and BV assays • To determine the relationship between bacterial community in the vagina and that in the rectum
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 25/09/2024
Actual trial start date 25/09/2024
Anticipated date of last follow up 30/09/2025
Actual Last follow-up date 25/09/2025
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 127
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
BREC000068752024 BREC
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
Single Group Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Metronidazole 400mg orally twice daily 7 days Treatment for BV was based on the Southern African HIV Clinicians Society guideline for the management of sexually transmitted infections advises targeted treatment as part of an effort to abate antimicrobial resistance and promote antibiotic stewardship in the treatment of STI’s. The guideline recommends the use of Metronidazole 400mg as a twice daily dose for 7 days. The South African Medical Formulary indicates the use of Clindamycin 2% cream for the treatment of Bacterial vaginosis. Participants with Bv were treated with 400mg twice daily oral tablets of metronidazole for 7 days at the time of enrolment. For those with persistent BV at day 8, they were provided with Clindamycin 2% cream with vaginal inserters for use once daily for 7 days. 127
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Premenopausal women, 18 – 45 years old • BV by Amsel criteria (at least 3 of 4 criteria must be present) and/or Nugent score (if symptomatic, score ≥ 4, if asymptomatic ≥ 7). • HIV negative or positive (up to 20 people living with HIV will be included) based on antibody test at screening. • Not pregnant at screening/enrolment visit, and unlikely to have an early pregnancy per clinician’s assessment of last menstrual period and recent sexual activity. • Literate, willing and able to provide written informed consent • Willing and able to attend study visits and comply with study procedures, including self-sampling and completion of the daily diary STI positive for Chlamydia, gonorrhoea, symptomatic candidiasis or trichomoniasis positive at screening • Pregnant women • Illiterate women • Women who have had antibiotic treatment within the last 7 days • Clinically significant acute or chronic medical condition or other circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study or jeopardizes the safety or rights of the participant. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
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 29/08/2024 Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
BREC, Research Office, UKZN, Research Office Govan Mbeki Centre Westville Campus Durban, South Africa, Private Bag X 54001 Durban 4000 Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the impact of a standard course of oral MDZ treatment (400 mg twice per day for 7 days) on the vaginal microbiota of South African women with BV • To characterize the level of resistance of the vaginal microbiota with high G. vaginalis relative abundance before and after BV treatment with MDZ Day 8 - following completion of 7 days of Metronidazole 400mg twice daily oral tablets for 7 days
Secondary Outcome To assess the proportion of women with recurrent or persistent BV on Day 8, 16 and 24 follow-up visits. • To assess whether MDZ and clindamycin treatment levels correlate with BV-linked microbiota resistance in vivo. • To characterise re-emerging Lactobacillus species after culturing with MDZ treatment and endolysin BNT331. • To assess the in vitro efficacy of the endolysin BNT331 against Gardnerella strains and other bacterial species found within the persistent or recurrent polymicrobial outgrowth of anaerobic microbiota using the human Vagina Chip and eVOLVER models. • To establish a biobank of diverse vaginal microbiota strains isolated from samples both before and after MDZ treatment. • To evaluate new STI and BV assays • To determine the relationship between bacterial community in the vagina and that in the rectum Day 8 following completion of 7 days of oral 400mg metronidazole oral tablets twice daily. Day 16 - indicated persistence in those who completed Clindamycin cream or show recurrence.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CAPRISA Ethekwini Clinical Research Site 3 University Avenue, Berea, Greyville, Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle WA 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle WA 98109 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
BioNTech Helmut-Qualtinger-Gasse 2 Vienna 1030 Austria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Upasna Singh upasna.singh@caprisa.org 0316550631 3 University Avenue, Berea, Greyville
City Postal code Country Position/Affiliation
Durban 4001 South Africa CAPRISA
Role Name Email Phone Street address
Scientific Enquiries Sinaye Ngcapu sinaye.ngcapu@caprisa.org 0316550539 3 University Avenue, Berea, Greyville
City Postal code Country Position/Affiliation
Durban 4001 South Africa CAPRISA
Role Name Email Phone Street address
Public Enquiries Thobile Mhlongo thobile.mhlongo@caprisa.org 0678333045 3 University Avenue, Berea, Greyville
City Postal code Country Position/Affiliation
Durban 4001 South Africa CAPRISA
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The sponsor will register and disclose the existence of and the results of clinical studies as required by law. The disclosure of the final study results will be performed after the end of study in order to ensure the statistical analyses are relevant. Informed Consent Form,Study Protocol The scientists involved in this study will disseminate the results from this research as broadly as possible. We expect that all the research personnel involved in this study will attend local, national and international conferences periodically and present the results from this research to the scientific community. The data from this project will be made available through the CAPRISA website data portal within 12months of study completion or when the primary paper of the findings is published, if this is sooner than 12months. In addition, the trial data will be made available to researchers at all the participating partner institutions in order to encourage the preparation of manuscripts from the trial dataset. All data will be owned jointly by the consortium conducting the project and each consortium member will have a complete set of the data for independent analysis after publication of the primary manuscript. Once the data has been analysed and published it will be uploaded to the CAPRISA data repository. Other researchers seeking to access the data for verification and/or re-use will be able to submit data access requests for review by the CAPRISA Scientific Review Committee. In line with standard data access principles, CAPRISA will ensure that Metadata on the datasets will be made available. Anonymization and other measures will be taken to protect individual and personally identifiable information in the datasets. The sponsor will register and disclose the existence of and the results of clinical studies as required by law. The disclosure of the final study results will be performed after the end of study in order to ensure the statistical analyses are relevant. The results of the study will be reported in a Clinical Study Report generated by the sponsor and will contain data from all study sites that participated in the study as PP. Recruitment performance or specific expertise related to the nature and the key assessment parameters of the study will be used to determine a coordinating investigator for the study. Results of analyses performed after the Clinical Study Report has been issued will be reported in a separate report and will not require a revision of the Clinical Study Report. Study participant identifiers will not be used in publication of results. Any work created in connection with performance of the study and contained in the data that can benefit from copyright protection (except any publication by the investigator as provided for below) shall be the property of the sponsor as author and owner of copyright in such work. Consistent with Good Publication Practices and International Committee of Medical Journal Editors(ICMJE) guidelines, the sponsor shall have the right to publish such primary(multicenter) data and information without approval from the investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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 Public title 14/05/2026 Missing bracket CAP 098 (BV Study CAP 098 (BV Study)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 11/10/2024 PACTR Admin 25 Sep 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 10/06/2025 Protocol amended and enrollment number increased to 150participants across two CAPRISA research clinics. 30 Apr 2025 30 Sep 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/05/2026 updated final date 25 Sep 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 10/06/2025 Protocol amended and enrollment number increased to 150participants across two CAPRISA research clinics. 100 150
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/05/2026 updated final enrolment number 127
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 09/10/2024 Submission done before 25 September 2024. Recruitment started in the first week of October. Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 14/05/2026 Study completed. Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 19/06/2026 Updated inclusion criteria to read as one sentence per line as indicated by reviewer Premenopausal women, 18 – 45 years old • BV by Amsel criteria (at least 3 of 4 criteria must be present) and/or Nugent score (if symptomatic, score ≥ 4, if asymptomatic ≥ 7). • HIV negative or positive (up to 20 people living with HIV will be included) based on antibody test at screening. • Not pregnant at screening/enrolment visit, and unlikely to have an early pregnancy per clinician’s assessment of last menstrual period and recent sexual activity. • Literate, willing and able to provide written informed consent • Willing and able to attend study visits and comply with study procedures, including self-sampling and completion of the daily diary Premenopausal women, 18 – 45 years old • BV by Amsel criteria (at least 3 of 4 criteria must be present) and/or Nugent score (if symptomatic, score ≥ 4, if asymptomatic ≥ 7). • HIV negative or positive (up to 20 people living with HIV will be included) based on antibody test at screening. • Not pregnant at screening/enrolment visit, and unlikely to have an early pregnancy per clinician’s assessment of last menstrual period and recent sexual activity. • Literate, willing and able to provide written informed consent • Willing and able to attend study visits and comply with study procedures, including self-sampling and completion of the daily diary
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 19/06/2026 Updated exclusion criteria to read as one sentence per line as indicated by reviewer Chlamydia, gonorrhoea, symptomatic candidiasis or trichomoniasis positive at screening • Pregnant women • Illiterate women • Women who have had antibiotic treatment within the last 7 days • Clinically significant acute or chronic medical condition or other circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study or jeopardises the safety or rights of the participant. STI positive for Chlamydia, gonorrhoea, symptomatic candidiasis or trichomoniasis positive at screening • Pregnant women • Illiterate women • Women who have had antibiotic treatment within the last 7 days • Clinically significant acute or chronic medical condition or other circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study or jeopardizes the safety or rights of the participant.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 19/06/2026 Updated as per comment from reviewer for further elaboration on intervention choice. Experimental Group, Metronidazole, 400mg orally twice daily, 7 days, Treatment for BV, 100, Experimental Group, Metronidazole, 400mg orally twice daily, 7 days, Treatment for BV was based on the Southern African HIV Clinicians Society guideline for the management of sexually transmitted infections advises targeted treatment as part of an effort to abate antimicrobial resistance and promote antibiotic stewardship in the treatment of STI’s. The guideline recommends the use of Metronidazole 400mg as a twice daily dose for 7 days. The South African Medical Formulary indicates the use of Clindamycin 2% cream for the treatment of Bacterial vaginosis. Participants with Bv were treated with 400mg twice daily oral tablets of metronidazole for 7 days at the time of enrolment. For those with persistent BV at day 8, they were provided with Clindamycin 2% cream with vaginal inserters for use once daily for 7 days. , 100,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/06/2026 Updated as per comment from reviewer for further elaboration on intervention choice. Experimental Group, Metronidazole, 400mg orally twice daily, 7 days, Treatment for BV was based on the Southern African HIV Clinicians Society guideline for the management of sexually transmitted infections advises targeted treatment as part of an effort to abate antimicrobial resistance and promote antibiotic stewardship in the treatment of STI’s. The guideline recommends the use of Metronidazole 400mg as a twice daily dose for 7 days. The South African Medical Formulary indicates the use of Clindamycin 2% cream for the treatment of Bacterial vaginosis. Participants with Bv were treated with 400mg twice daily oral tablets of metronidazole for 7 days at the time of enrolment. For those with persistent BV at day 8, they were provided with Clindamycin 2% cream with vaginal inserters for use once daily for 7 days. , 100, Experimental Group, Metronidazole, 400mg orally twice daily, 7 days, Treatment for BV was based on the Southern African HIV Clinicians Society guideline for the management of sexually transmitted infections advises targeted treatment as part of an effort to abate antimicrobial resistance and promote antibiotic stewardship in the treatment of STI’s. The guideline recommends the use of Metronidazole 400mg as a twice daily dose for 7 days. The South African Medical Formulary indicates the use of Clindamycin 2% cream for the treatment of Bacterial vaginosis. Participants with Bv were treated with 400mg twice daily oral tablets of metronidazole for 7 days at the time of enrolment. For those with persistent BV at day 8, they were provided with Clindamycin 2% cream with vaginal inserters for use once daily for 7 days. , 127,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 Updated as per comment from reviewer. Primary Outcome, To evaluate the impact of a standard course of oral MDZ treatment (400 mg twice per day for 7 days) on the vaginal microbiota of South African women with BV • To characterize the level of resistance of the vaginal microbiota with high G. vaginalis relative abundance before and after BV treatment with MDZ, Day 8 Primary Outcome, To evaluate the impact of a standard course of oral MDZ treatment (400 mg twice per day for 7 days) on the vaginal microbiota of South African women with BV • To characterize the level of resistance of the vaginal microbiota with high G. vaginalis relative abundance before and after BV treatment with MDZ, Day 8 - following completion of 7 days of Metronidazole 400mg twice daily oral tablets for 7 days
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/06/2026 Response to comment to clarify what day 8 and day 16 represent in terms of treatment exposure. Secondary Outcome, To assess the proportion of women with recurrent or persistent BV on Day 8, 16 and 24 follow-up visits. • To assess whether MDZ and clindamycin treatment levels correlate with BV-linked microbiota resistance in vivo. • To characterise re-emerging Lactobacillus species after culturing with MDZ treatment and endolysin BNT331. • To assess the in vitro efficacy of the endolysin BNT331 against Gardnerella strains and other bacterial species found within the persistent or recurrent polymicrobial outgrowth of anaerobic microbiota using the human Vagina Chip and eVOLVER models. • To establish a biobank of diverse vaginal microbiota strains isolated from samples both before and after MDZ treatment. • To evaluate new STI and BV assays • To determine the relationship between bacterial community in the vagina and that in the rectum, Day 8 and Day 16 Secondary Outcome, To assess the proportion of women with recurrent or persistent BV on Day 8, 16 and 24 follow-up visits. • To assess whether MDZ and clindamycin treatment levels correlate with BV-linked microbiota resistance in vivo. • To characterise re-emerging Lactobacillus species after culturing with MDZ treatment and endolysin BNT331. • To assess the in vitro efficacy of the endolysin BNT331 against Gardnerella strains and other bacterial species found within the persistent or recurrent polymicrobial outgrowth of anaerobic microbiota using the human Vagina Chip and eVOLVER models. • To establish a biobank of diverse vaginal microbiota strains isolated from samples both before and after MDZ treatment. • To evaluate new STI and BV assays • To determine the relationship between bacterial community in the vagina and that in the rectum, Day 8 following completion of 7 days of oral 400mg metronidazole oral tablets twice daily. Day 16 - indicated persistence in those who completed Clindamycin cream or show recurrence.