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Objectives: To describe the safety and the clinical and microbiological efficacy of a single oral dose of a combined treatment with secnidazole plus fluconazole for the syndromic management of symptomatic vaginal discharge.
Materials and methods: A clinical trial without control group study was conducted including women with symptomatic vaginal discharge who assisted to a secondary level hospital in Bogota, Colombia. 118 women were included in a consecutive convenience sample who received the study treatment according to syndromic diagnosis approach. Microbiological diagnosis of bacterial vaginosis (BV) was confirmed by Nugent score, yeast infection by candida culture and trichomoniasis by wet mount. Prevalence, clinical and microbioogical efficacy and safety of the secnidazole and fluconazole combination pill was determined and a sensitivity analysis for treatment efficacy was performed.
Results: The following infections were found: BV in 57.1%, candidiasis in 28.8%, and mixed infections in 10.8%. In 8.5% of the patients, the microbiology tests were negative. No trichomonas were found. The clinical cure rate was 90.4%, and the microbiological cure rate was 94.1% with the study medication. Twelve cases (12.90%) presented drug-related non serious adverse events.
Conclusion: The most prevalent infection was BV, followed by candidiasis and mixed infection. The combination of a single dose of secnidazole plus fluconazole combined pill had an efficacy rate over 90% and was safe for the treatment of symptomatic women with vaginal discharge.