Activities of Metronidazole + Clotrimazole in the treatment and prophylaxis of recurrent vaginal infections recurrent Candida albicans and Candida albicans spp do not.
- Conditions
- women with vaginal infections by Candida albicans and non-albicans Candida spp relapsing recurrent (= 4 events / year) in the acute phase of the disease.MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2011-004718-40-IT
- Lead Sponsor
- AISAR ASSOCIAZIONE ITALIANA PER LO STUDIO DEGLI ANTIMICROBICI E DELLE RESISTENZE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Women will be recruited (age range 18-50) with a vaginal infection by Candida albicans and non-albicans Candida spp relapsing recurrent (= 4 events / year) in the acute phase of the disease.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Are not eligible for the study, patients who refuse consent baccalaureate study, in the case of taking birth control and pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Measuring the incidence of healing and the reduction of recurrent vulvovaginal candidiasis events following treatment with the combination of Metronidazole - Clotrimazole;Secondary Objective: Define dose and timing of treatment more effective for prophylaxis with relapse;Primary end point(s): Vulvovaginal candidiasis reduction of recurrent events following treatment with the combination of Metronidazole - Clotrimazole;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Improving the average health of patients;Timepoint(s) of evaluation of this end point: 3 months