NCT00667368

Bacterial Vaginosis Home Screening to Prevent STDs

Completed Phase 3 Results posted Last updated 18 February 2020

What this trial tests

Phase 3 trial testing Metronidazole in Bacterial Vaginosis in 1,370 participants. Completed in 31 December 2014.

Timeline

28 July 2008

Primary endpoint
31 December 2014

31 December 2014

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,370
Start date	28 July 2008
Primary completion	31 December 2014
Estimated completion	31 December 2014
Sites	7 locations across United States

Drugs / interventions tested

• Metronidazole (METRONIDAZOLE) — full drug profile →

Conditions studied

• Bacterial Vaginosis — all drugs for Bacterial Vaginosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 15 to 25, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment Primary · At 4, 8, and 12 months after enrollment.

Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.

Group	Value	95% CI
Control	19.2	15.9 – 23.2
Intervention	18.3	15.1 – 22.1

Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months Secondary · 2, 4, 6, 8, 10, 12 months after enrollment

Percentage of women testing positive for BV at any follow-up visit. The outcome of BV status was determined by self-collected vaginal swab specimens that were evaluated by the Nugent criteria. A Nugent score of 7-10 indicates positive for BV.

Group	Value	95% CI
Control	92.5
Intervention	82.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months after enrollment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control

Serious: 3/682 (0%)

Deaths: —

Intervention

Serious: 7/683 (1%)

Deaths: —

Serious adverse events (10 terms)

Reaction	System	Control	Intervention
Wound Infection	Infections and infestations	—	—
Intervertebral Disk Protrusion	Musculoskeletal and connective tissue disorders	—	—
Turbo-Ovarian Abscess	Reproductive system and breast disorders	—	—
Demyelination	Nervous system disorders	—	—
Optic Neuritis	Nervous system disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Convulsion	Nervous system disorders	—	—
Postpartum Haemorrhage	Pregnancy, puerperium and perinatal conditions	—	—
Premature Labour	Pregnancy, puerperium and perinatal conditions	—	—
Abscess Limb	Infections and infestations	—	—

Most-reported serious reactions: Wound Infection, Intervertebral Disk Protrusion, Turbo-Ovarian Abscess, Demyelination, Optic Neuritis, Vomiting, Convulsion, Postpartum Haemorrhage.

Data from ClinicalTrials.gov NCT00667368 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV \[infection of the vagina\]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4, 8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2 possible study groups: the intervention group (treatment of BV) or the control group (no BV treatment). Every 2 months, subjects will complete a home self-testing kit for screening of BV using a swab. If BV is detected by self-test, the subjects in the interventional group will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in study related procedures for up to 12 months.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Home Screening for Bacterial Vaginosis to Prevent Sexually Transmitted Diseases.
   Schwebke JR, Lee JY, Lensing S, Philip SS, et al · · 2016 · cited 13× · PMID 26611782 · DOI 10.1093/cid/civ975
2. Effect of metronidazole on vaginal microbiota associated with asymptomatic bacterial vaginosis.
   Ruiz-Perez D, Coudray MS, Colbert B, Krupp K, et al · · 2021 · cited 7× · PMID 34151180 · DOI 10.1099/acmi.0.000226
3. Longitudinal assessment of nonavalent vaccine HPV types in a sample of sexually active African American women from ten U.S. Cities.
   Madhivanan P, Krupp K, Coudray M, Colbert B, et al · · 2021 · PMID 34294478 · DOI 10.1016/j.vaccine.2021.07.026