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Bacterial Vaginoses clinical trials

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NCT ID: NCT04189744 Completed - Bacterial Vaginoses Clinical Trials

The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract

Start date: December 15, 2019
Phase: Phase 3
Study type: Interventional

Malaria in pregnancy has devastating consequences for mother and foetus. WHO recommends intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) for asymptomatic women, but high-level parasite resistance to SP threatens its efficacy. Dihydroartemisinin-piperaquine (DP) has the potential to replace SP for IPTp. However, the DP strategy has not been found to be superior to SP for reducing the incidence of low birthweight (LBW), small-for-gestational age (SGA), or preterm birth. This may be the result of sulphadoxine having antibacterial properties; it is derived from sulphonamide, which have been used for decades to treat curable STIs/RTIs. However, SP is unlikely to be curative of STIs/RTIs, nor highly effective against malaria parasites. Thus, combination treatment that contains a more efficacious antimalarial and a more efficacious anti-STI/RTI may produce better birth outcomes. The investigators will therefore determine whether combining SP with metronidazole (MTZ) or, separately, DP with MTZ can improve birth outcomes more than SP alone, potentially paving the way for integrated control strategies that will reduce the dual burden of malaria and curable STIs/RTIs. This is an individually-randomized, 3-arm, partially-placebo controlled superiority trial comparing the efficacy, safety and tolerance of IPTp-SP versus IPTp-SP with MTZ, or IPTp-DP with MTZ to reduce adverse birth outcomes attributable to malaria and curable STIs/RTIs in 5,436 women in the Nchelenge District of Zambia.

NCT ID: NCT04057482 Completed - Bacterial Vaginoses Clinical Trials

Treatment of BV With Donaxyl and a Molecular Test of Cure

Start date: May 2015
Phase:
Study type: Observational

. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.

NCT ID: NCT03954990 Terminated - Bacterial Vaginoses Clinical Trials

Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Start date: October 11, 2019
Phase: Phase 1
Study type: Interventional

Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities

NCT ID: NCT03937869 Completed - Bacterial Vaginoses Clinical Trials

Evaluate the Safety of a Single Oral Dose of Solosecâ„¢ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV

Start date: November 28, 2018
Phase: Phase 4
Study type: Interventional

A multi-center, open-label study to evaluate the treatment of one oral dose of 2g Solosecâ„¢ (Secnidazole) in adolescent girls with BV

NCT ID: NCT03878511 Completed - Bacterial Vaginoses Clinical Trials

Therapeutic Lactose to Support Vaginal Microbiota

Start date: November 1, 2012
Phase: N/A
Study type: Interventional

The aim of the study was to investigate whether the administration of a vaginal tablet containing lactose can modulate the bacterial flora of women with bacterial vaginosis (BV). Design: Double-blind, placebo-controlled randomised trial. Setting: Women with BV who responded to advertisements in local newspapers and on posters at the Institutions for Education in Health Science in Eastern Jutland, Denmark. These individuals were supplemented with patients enrolled at a gynaecological clinic. Participants: Forty women with BV diagnosed through the Amsel test. By randomisation, 20 were assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets. Interventions: Twice daily application of one lactose tablet or placebo tablet for 7 days.

NCT ID: NCT03837015 Completed - HIV-1-infection Clinical Trials

Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women

Start date: November 4, 2019
Phase: Phase 1
Study type: Interventional

This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.