Dataset Information

Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data.

ABSTRACT:

Objectives

Bacterial vaginosis (BV) and trichomoniasis are the most common causes of vaginitis. Both infections are associated with increased risk of acquisition and transmission of HIV and other sexually transmitted infections as well as adverse reproductive health outcomes. Co-infection is common, with rates ranging from 60% to 80%. We evaluated the efficacy of single-dose oral secnidazole 2 g for the treatment of trichomoniasis in a subgroup of women co-infected with BV and trichomoniasis.

Design

Post hoc analysis of data from a phase 3 randomised, double-blind, placebo-controlled, delayed-treatment study.

Setting

10 centres in the USA.

Participants

Subgroup of women (aged ≥12 years) with a confirmed diagnosis of Trichomonas vaginalis and co-infection with BV clinically diagnosed using Amsel's criteria.

Intervention

Single dose of secnidazole 2 g or placebo.

Outcome measures

The primary efficacy outcome was the microbiological cure (negative culture for T. vaginalis) at the test of cure (TOC) visit 6-12 days after dosing in the modified intent-to-treat population (mITT). At TOC, participants received the opposite treatment.

Results

Of the 131 T. vaginalis-infected participants in the mITT, 79 (60.3%) met ≥3 Amsel's criteria for BV at enrolment. Microbiological cure rates for trichomoniasis at TOC among this subgroup of women were 97.7% (42/43) for secnidazole and 0% (0/36) for placebo.

Conclusion

Single-dose oral secnidazole 2 g was highly efficacious in curing trichomoniasis in women co-infected with BV. Appropriate and effective treatment options for co-infection are essential for reducing transmission and reinfection. Secnidazole is the only single-dose medication approved by the Food and Drug Administration for the treatment of BV in women and trichomoniasis in women and men.

Trial registration number

ClinicalTrials.gov, NCT03935217; post-results.

SUBMITTER: Muzny CA

PROVIDER: S-EPMC10407359 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data.

Muzny Christina A CA Van Gerwen Olivia T OT Kaufman Gregory G Chavoustie Steven S

BMJ open 20230807 8

<h4>Objectives</h4>Bacterial vaginosis (BV) and trichomoniasis are the most common causes of vaginitis. Both infections are associated with increased risk of acquisition and transmission of HIV and other sexually transmitted infections as well as adverse reproductive health outcomes. Co-infection is common, with rates ranging from 60% to 80%. We evaluated the efficacy of single-dose oral secnidazole 2 g for the treatment of trichomoniasis in a subgroup of women co-infected with BV and trichomoni ...[more]

PMID: 37550019

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Project description:BACKGROUND:Bacterial vaginosis (BV) is one of the common vaginal infections among childbearing women. The usual treatment for BV is metronidazole; hence 30% of women have recurrence within 60 to 90 days after treatment. There are some studies which assessed the effect of secnidazole on BV. The aim of this systematic review was to investigate the effectiveness of secnidazole for treatment of BV. METHODS:The Cochrane Library, MEDLINE (PubMed), Scopus, and Web of Science (all databases from inception till October 28, 2018) were searched. Primary outcomes were clinical cure rate and microbiologic cure rate and the secondary outcomes were adverse events. Data was extracted from eligible studies by two review authors individually and analyzed by RevMan 5.3. RESULTS:Our search found six trials involving 1528 participants. Treatment with 2 g secnidazole could significantly reduce the risk of BV in patients with three or less episodes of BV in the last year by OR: 7.54 (95% CI, 3.89-14.60, p < 0.00001) and in patients with four or more episodes of BV in the last year (OR: 4.74, 95% CI: 1.51-14.84, p = 0.0.008). Secnidazole (2 g) could significantly increase the microbiologic cure rate in women with 3 or less episodes of BV in the last year (OR: 7.63, 95% CI: 2.30-25.33, p = 0.0009) but not in the women with 4 or more episodes of BV in the last year (OR: 20.17, 95% CI: 1.06-382.45, p = 0.05). The clinical cure rate, microbiological effect and the therapeutic cure rate of 2 g secnidazole was significantly more than that of 1 g secnidazole. The results showed that the clinical cure rate of 2 g secnidazole was not different from the following medications: metronidazole (500 mg bid for 5 days), secnidazole plus vaginal metronidazole, 2 g single dose of oral metronidazole and 2 g secnidazole plus vaginal ornidazole. CONCLUSION:This review showed that 2 g and 1 g secnidazole were better than placebo, however, 2 g secnidazole was more effective than 1 g. Secnidazole 2 g was not different from metronidazole (500 mg bid for 5 days), or from secnidazole plus vaginal metronidazole, or 2 g single dose of oral metronidazole or from 2 g secnidazole plus vaginal ornidazole.

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Dataset Information

Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data.

Objectives

Design

Setting

Participants

Intervention

Outcome measures

Results

Conclusion

Trial registration number

Publications

Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data.

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