• About Us
    • Contact Us
    • Login
    • ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
About Us Contact Us Login ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
Grand Rounds

RCT Results: Efficacy and Safety of Secnizadole for Treatment of Trichomoniasis

image_pdfFavoriteLoadingFavorite

BACKGROUND AND PURPOSE:

  • Secnidazole: 5-nitroimidazole antibiotic with a longer half-life than metronidazole or tinidazole | Single dose | Oral granules
  • Muzny et al. (Clinical Infectious Diseases, 2021) assessed the efficacy and safety of secnidazole in women with trichomoniasis

METHODS:

  • Phase 3, randomized, double-blind, placebo-controlled trial
  • Participants
    • Women with trichomoniasis confirmed by a positive T. vaginalis culture
  • Interventions
    • Single-dose oral secnidazole 2g
    • Placebo
  • Study design
    • At the test of cure visit at 6 to 12 days, based on positive T. vaginalis culture, participants were given the opposite treatment
      • Infection resolved: Discharged from study
      • Infection still present: Returned for visit 7 to 12 days later for assessment and treatment
      • Additional visits and treatments based on care provider discretion
  • Power analysis
    • Assumptions: Microbiological cure rates of 75% (secnidazole) and 40% (placebo)
  • 95% power | α=0.05 level of significance
  • Sample size: 100 patients (50 patients/group)
  • Analysis was by modified intent-to-treat
  • Primary outcome
    • Microbiological test of cure (TOC) by culture 6 to 12 days after dosing

RESULTS:

  • 131 patients
    • Secnidazole: 64 patients
    • Placebo: 67 patients
  • Cure rates were significantly higher in the secnidazole group (modified intent-to-treat population)
    • Secnidazole: 92.2% (95% CI, 82.7 to 97.4)
    • Placebo: 1.5% (95% CI, 0.0 to 8.0)
  • Rates were similar in the per-protocol population
  • Cure rates in subpopulations
    • Women with HIV: 100% (4/4 women)
    • Women with bacterial vaginosis: 95.2% (20/21 women)
  • Most frequently reported adverse events with secnidazole
    • Vulvovaginal candidiasis: 2.7%
    • Nausea: 2.7%
  • No serious adverse effects were reported

CONCLUSION:

  • For women with trichomoniasis, a single dose of 2g secnidazole was associated with a higher cure rate vs placebo
    • These higher cure rates were consistent in women with HIV and bacterial vaginosis
  • The medication as well tolerated, with few adverse effects reported
  • The authors note that pregnant women were not included in the study, however

Future studies should be considered in pregnant women and those with persistent T. vaginalis infection 

Learn More – Primary Sources:

Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study

Want to stay on top of key guidelines and research papers?

ObGFirst® – Try It Free! »

image_pdfFavoriteLoadingFavorite
< Previous
All Grand Rounds Posts
Next >

Related ObG Topics:

Trichomoniasis: CDC Diagnosis and Treatment Guidelines
FDA Approves Secnidazole: Single-Dose Oral Treatment for BV
Practical info for your gynecology practice
Diagnosing Vaginitis – Why the Office Visit Still Matters
Practical obstetrics info for your women's healthcare practice
STI Screening in Pregnancy: CDC Recommendations
Sexually Transmitted Diseases and Partner Notification

Sections

  • COVID-19
  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • Grand Rounds
  • My Bookshelf
  • Now@ObG
  • Media

Are you an
ObG Insider?

Get specially curated clinical summaries delivered to your inbox every week for free

  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Download Your ObG App
HERE!

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site