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Jane R. Schwebke - One of the best experts on this subject based on the ideXlab platform.

  • In Vitro Study of the Susceptibility of Clinical Isolates of Trichomonas vaginalis to Metronidazole and Secnidazole.
    Antimicrobial agents and chemotherapy, 2018
    Co-Authors: Arindam P. Ghosh, C. Aycock, Jane R. Schwebke
    Abstract:

    Nitroimidazoles (metronidazole [MTZ] and tinidazole [TNZ]) are the only drugs recommended for treatment of Trichomonas vaginalis infections. MTZ resistance occurs in 4% to 10% of cases of vaginal trichomoniasis (R. D. Kirkcaldy et al., Emerg Infect Dis 18:939-943, 2012; J. R. Schwebke and F. J. Barrientes, Antimicrob Agents Chemother 50:4209-4210, 2006) and TNZ resistance in 1% of cases (J. R. Schwebke and F. J. Barrientes, Antimicrob Agents Chemother 50:4209-4210, 2006). Emerging nitroimidazole-resistant trichomoniasis is concerning, because few alternatives to standard therapy exist. We assessed the prevalence of in vitro aerobic MTZ and Secnidazole resistance among T. vaginalis isolates collected in 2015 to 2016 from 100 women in Birmingham, Alabama, with positive cultures. Archived specimens were treated with Secnidazole or MTZ (0.2 to 400 μg/ml) for 48 h, according to U.S. Centers for Disease Control and Prevention protocols. Ninety-six (96%) of the 100 clinical Trichomonas isolates tested demonstrated lower minimum lethal concentrations for Secnidazole than for MTZ, suggesting that Secnidazole has better in vitro activity than MTZ.

  • Secnidazole: next-generation antimicrobial agent for bacterial vaginosis treatment.
    Future microbiology, 2018
    Co-Authors: Paul Nyirjesy, Jane R. Schwebke
    Abstract:

    Secnidazole is a next-generation 5-nitroimidazole approved for more than three decades in Europe, Asia, South America and Africa and recently in the USA as a single-dose (2 g) treatment of bacterial vaginosis (BV). Secnidazole is characterized by potent in vitro antimicrobial activity against BV-associated pathogens, as well as prolonged terminal elimination half-life and systemic exposure. These characteristics form the basis of effective and safe treatment of BV with a 2-g single-dose Secnidazole regimen, which was recently confirmed in double-blind, placebo-controlled clinical trials conducted in the USA. The option to treat BV with single-dose Secnidazole not only cures the primary infection but also may diminish risks of serious sequelae of untreated or undertreated infection.

  • a phase 3 multicenter prospective open label study to evaluate the safety of a single dose of Secnidazole 2 g for the treatment of women and postmenarchal adolescent girls with bacterial vaginosis
    Journal of Womens Health, 2018
    Co-Authors: Steven E Chavoustie, Janet K Gersten, Milroy J Samuel, Jane R. Schwebke
    Abstract:

    Abstract Background: A novel formulation of Secnidazole is under development in the United States for the treatment of bacterial vaginosis (BV). Efficacy and safety of other formulations of Secnidazole have been reported. The objective of this study is to evaluate the safety of a single-dose oral granule formulation of Secnidazole in a U.S. population of women with BV. Methods: In this open-label study, patients were enrolled based on the following criteria: off-white, thin, homogeneous vaginal discharge; vaginal pH ≥4.7; presence of ≥20% clue cells; and positive potassium hydroxide whiff test. Eligible patients received a single dose of Secnidazole 2 g at baseline. Patients were contacted on days 8–10 and were assessed for safety at an end-of-study visit (days 21–30). Additional endpoints included investigator assessment of the need for additional treatment and a post hoc analysis of clinical response to treatment. Results: Of 321 patients, 283 (88.2%) completed the study. The mean age was 32 ± 8.5 years...

  • a phase 3 double blind placebo controlled study of the effectiveness and safety of single oral doses of Secnidazole 2 g for the treatment of women with bacterial vaginosis
    American Journal of Obstetrics and Gynecology, 2017
    Co-Authors: Jane R. Schwebke, Franklin G Morgan, William D Koltun, Paul Nyirjesy
    Abstract:

    Background A novel single oral dose granule formulation of Secnidazole 2 g, a 5-nitroimidazole with a longer half-life (∼17 hours) than metronidazole (∼8 hours), is being developed to treat bacterial vaginosis. Objective We sought to evaluate the effectiveness and safety of single-dose Secnidazole 2 g compared to placebo for the treatment of women with bacterial vaginosis. Study Design In all, 189 women with bacterial vaginosis were randomized 2:1 to receive a single oral dose of Secnidazole 2 g (N = 125) or matched placebo (N = 64) at 21 centers in the United States. The primary endpoint was the proportion of clinical outcome responders, defined as those with: (1) normal vaginal discharge; (2) negative 10% potassium hydroxide whiff test; and (3) Results Single-dose Secnidazole 2 g was superior to placebo for the primary and all secondary efficacy measures in the modified intent-to-treat population, with clinical outcome responder rates of 53.3% (57/107) vs 19.3% (11/57; P P P Conclusion Single-dose Secnidazole 2 g was superior to placebo on all primary and secondary outcomes and was well tolerated; these results support its role for the treatment of women with bacterial vaginosis.

Paul Nyirjesy - One of the best experts on this subject based on the ideXlab platform.

  • Secnidazole: next-generation antimicrobial agent for bacterial vaginosis treatment.
    Future microbiology, 2018
    Co-Authors: Paul Nyirjesy, Jane R. Schwebke
    Abstract:

    Secnidazole is a next-generation 5-nitroimidazole approved for more than three decades in Europe, Asia, South America and Africa and recently in the USA as a single-dose (2 g) treatment of bacterial vaginosis (BV). Secnidazole is characterized by potent in vitro antimicrobial activity against BV-associated pathogens, as well as prolonged terminal elimination half-life and systemic exposure. These characteristics form the basis of effective and safe treatment of BV with a 2-g single-dose Secnidazole regimen, which was recently confirmed in double-blind, placebo-controlled clinical trials conducted in the USA. The option to treat BV with single-dose Secnidazole not only cures the primary infection but also may diminish risks of serious sequelae of untreated or undertreated infection.

  • a phase 3 double blind placebo controlled study of the effectiveness and safety of single oral doses of Secnidazole 2 g for the treatment of women with bacterial vaginosis
    American Journal of Obstetrics and Gynecology, 2017
    Co-Authors: Jane R. Schwebke, Franklin G Morgan, William D Koltun, Paul Nyirjesy
    Abstract:

    Background A novel single oral dose granule formulation of Secnidazole 2 g, a 5-nitroimidazole with a longer half-life (∼17 hours) than metronidazole (∼8 hours), is being developed to treat bacterial vaginosis. Objective We sought to evaluate the effectiveness and safety of single-dose Secnidazole 2 g compared to placebo for the treatment of women with bacterial vaginosis. Study Design In all, 189 women with bacterial vaginosis were randomized 2:1 to receive a single oral dose of Secnidazole 2 g (N = 125) or matched placebo (N = 64) at 21 centers in the United States. The primary endpoint was the proportion of clinical outcome responders, defined as those with: (1) normal vaginal discharge; (2) negative 10% potassium hydroxide whiff test; and (3) Results Single-dose Secnidazole 2 g was superior to placebo for the primary and all secondary efficacy measures in the modified intent-to-treat population, with clinical outcome responder rates of 53.3% (57/107) vs 19.3% (11/57; P P P Conclusion Single-dose Secnidazole 2 g was superior to placebo on all primary and secondary outcomes and was well tolerated; these results support its role for the treatment of women with bacterial vaginosis.

Helen Marie Judge - One of the best experts on this subject based on the ideXlab platform.

  • Secnidazole for treatment of bacterial vaginosis a systematic review
    BMC Women's Health, 2019
    Co-Authors: Mohamed Abd El A Aziz, Foruzan Sharifipour, Parvin Abedi, Shayesteh Jahanfar, Helen Marie Judge
    Abstract:

    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. 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. 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. 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.

  • Secnidazole for treatment of bacterial vaginosis: a systematic review
    BMC women's health, 2019
    Co-Authors: Mohamed Abd El A Aziz, Foruzan Sharifipour, Parvin Abedi, Shayesteh Jahanfar, Helen Marie Judge
    Abstract:

    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. 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. 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 

Sharon Levy - One of the best experts on this subject based on the ideXlab platform.

  • An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis
    Reproductive Sciences, 2020
    Co-Authors: Helen Pentikis, Nikki Adetoro, Diane Tipping, Sharon Levy
    Abstract:

    Bacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of Secnidazole 2 g (SOLOSEC™ [Secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of Secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of Secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose Secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate ( P  

  • An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis.
    Reproductive sciences (Thousand Oaks Calif.), 2020
    Co-Authors: Helen S. Pentikis, Nikki Adetoro, Diane Tipping, Sharon Levy
    Abstract:

    Bacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of Secnidazole 2 g (SOLOSEC™ [Secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of Secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of Secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose Secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose Secnidazole 2 g granules as treatment for women with BV.

Mohamed Abd El A Aziz - One of the best experts on this subject based on the ideXlab platform.

  • Secnidazole for treatment of bacterial vaginosis a systematic review
    BMC Women's Health, 2019
    Co-Authors: Mohamed Abd El A Aziz, Foruzan Sharifipour, Parvin Abedi, Shayesteh Jahanfar, Helen Marie Judge
    Abstract:

    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. 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. 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. 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.

  • Secnidazole for treatment of bacterial vaginosis: a systematic review
    BMC women's health, 2019
    Co-Authors: Mohamed Abd El A Aziz, Foruzan Sharifipour, Parvin Abedi, Shayesteh Jahanfar, Helen Marie Judge
    Abstract:

    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. 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. 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