La trichomonase urogénitale. Essais d'un imidazole à demi-vie longue : le secnidazole

Siboulet, A; Catalán, F; Videau, D; Niel, Guillaume van

doi:10.1016/s0399-077x(77)80094-2

Cited by 11 publications

(13 citation statements)

References 2 publications

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“…Other limitations include the lack of long-term follow-up and the exclusion of men and pregnant women. However, 2 non-US-based studies of SEC for trichomoniasis in patients, including a small subgroup of men, showed cure rates of 91.7%–100% at 2–20 days after treatment [ 30 , 31 ]. Although our study did not include pregnant women, and data on the use of SEC during pregnancy are limited, reproductive preclinical toxicology studies have shown no evidence of toxicity, and SEC is not contraindicated during pregnancy [ 14 , 32 ].…”

Section: Discussionmentioning

confidence: 99%

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

Muzny

Schwebke

Nyirjesy

et al. 2021

Clinical Infectious Diseases

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Background Trichomonas vaginalis is the most prevalent non-viral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs. placebo in women with trichomoniasis. Methods Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2g or placebo. The primary endpoint was microbiological test of cure (TOC) by culture 6–12 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits, if needed. Fifty patients per group (N=100) provided ~95% power to detect a statistically significant difference between treatment groups. Results Between April 2019 and March 2020, 147 women enrolled at 10 US sites. The modified intent-to-treat (mITT) population included 131 randomized patients (64/67, in secnidazole/placebo). Cure rates were significantly higher in the secnidazole vs. placebo group (92.2% [95% CI: 82.7–97.4] vs. 1.5% [95% CI: 0.0–8.0]) for the mITT population and for the per-protocol population (94.9% [95% CI: 85.9–98.9]) vs. 1.7% [95% CI: 0.0–8.9]). Cure rates were 100% (4/4) in women with HIV and 95.2% (20/21) in women with bacterial vaginosis (BV). Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea (each 2.7%). No serious TEAEs were observed. Conclusion A single oral 2g dose of secnidazole was associated with significantly higher microbiological cure rates vs. placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and/or BV.

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Section: Discussionmentioning

confidence: 99%

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

Muzny

Schwebke

Nyirjesy

et al. 2021

Clinical Infectious Diseases

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“…Diagnostic and control samples were taken as previously described (Siboulet et al, 1977). The samples were examined microscopically-phase contrast and May-Grunwald-Giemsa stain-and cultured on Roiron's isolation medium , before treatment and 48 hours and 15 days after.…”

Section: Introductionmentioning

confidence: 99%

“…Details of the techniques are given elsewhere (Siboulet et al, 1977). The MIC and MTC estimations were made on 11 strains (one reference standard, maintained in the laboratory for 20 years, and 10 strains freshly isolated from humans) for each of the three drugsmetronidazole, secnidazole, and tinidazole.…”

Section: Introductionmentioning

confidence: 99%

Secnidazole. A 5-nitroimidazole derivative with a long half-life.

Videau¹,

Niel²,

Siboulet³

et al. 1978

Sexually Transmitted Infections

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SUMMARY The therapeutic activity of a single 2 g dose of secnidazole was studied in patients with urogenital trichomoniasis. In 140 patients, 97 % were cured and the drug was well tolerated. In the laboratory, tests on sensitivity were made and the minimal inhibitory concentration (MIC) and the minimal trichomonacidal concentration (MTC) were determined on cultures that had recently been isolated at the clinic, and the pharmacokinetic properties of secnidazole in man were compared with those of tinidazole. The therapeutic efficacy of all the metronidazole derivatives was reviewed and a single-dose treatment is recommended. Therapeutic and prophylactic treatment is achieved by products with a long half-life. Secnidazole, with a half-life of 14-3± 1*3 h (women) and 20 2+3 1 h (men), is particularly suitable for this type of treatment. IntroductionPatients and methods

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“…and adolescents 12 years or older based on the results of an RCT in the United States 23 and trials conducted in Europe. [24][25][26][27] This approval came after the updated CDC and American College of Obstetricians and Gynecologists guidelines were written; however, SEC is in both guidelines as an alternative treatment for bacterial vaginosis (BV). 5,6 The use of multidose oral MTZ to treat trichomoniasis in women presents unique challenges for the management of male sexual partners.…”

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confidence: 99%

Where Do Tinidazole and Secnidazole Fit in With the Treatment of Trichomoniasis?

Muzny

Kissinger

2023

Sexual Trans Dis

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T richomonas vaginalis is the most prevalent nonviral sexually transmitted infection (STI) worldwide, 1 affecting ~3.7 million individuals in the United States. 2 The prevalence is estimated to be 0.5% in men and 2.1% in women; rates are significantly higher in African American women (9.6%) versus Hispanic women (1.4%) and non-Hispanic White women (0.8%). 3,4 The true US prevalence is not known, as T. vaginalis is not reportable, and screening is only recommended in HIV-infected women. 5 Trichomoniasis is associated with multiple adverse health outcomes in women, including vaginitis, cervicitis, 6 cervical cancer, 7 pelvic inflammatory disease, 8,9 and adverse birth outcomes. 10,11 In men, it is associated with nongonococcal urethritis, 12,13 epididymitis, 14 prostatitis, and infertility. 15,16 It also is associated with HIVand other STIs in both sexes. 5,6,17 Despite its high prevalence and adverse outcomes, the significance of trichomoniasis is underappreciated in the medical community. [18][19][20] The 5-nitroimidazoles, including metronidazole (MTZ), tinidazole (TDZ), and secnidazole (SEC), are the only class of antimicrobial agents with confirmed effectiveness against T. vaginalis. 21 Until recently, the Centers for Disease Control and Prevention (CDC) STI Treatment Guidelines for trichomoniasis recommended a single 2-g dose of oral MTZ for HIV-negative women and men or, alternatively, a single 2-g dose of oral TDZ for women and men; multidose oral MTZ (500 mg twice daily for 7 days) was recommended for HIV-infected women. 5 In 2021, the CDC changed their treatment recommendation for all women with T. vaginalis to multidose oral MTZ, with single-dose 2-g oral TDZ remaining as an alternate. 5 This was in response to a randomized controlled trial (RCT) that found multidose oral MTZ to be superior to single-dose oral MTZ in HIV-negative women. 22 The American College of Obstetricians and Gynecologists updated their 2020 Clinical Management Guidelines in the same manner. 5,6 In contrast, a single 2-g dose of oral MTZ remains the recommended treatment for T. vaginalis-infected men, with a single 2-g dose of oral TDZ as an alternative. 5 Secnidazole, a next-generation 5-nitroimidazole with a longer half-life than MTZ or TDZ, 21 received Food and Drug Administration (FDA) approval for trichomoniasis in women, men,

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La trichomonase urogénitale. Essais d'un imidazole à demi-vie longue : le secnidazole

Cited by 11 publications

References 2 publications

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

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

Secnidazole. A 5-nitroimidazole derivative with a long half-life.

Where Do Tinidazole and Secnidazole Fit in With the Treatment of Trichomoniasis?

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