Oropharyngeal candidiasis Infections and Infestations Candidiasis
Conditions
Interventions
A bicenter, open-label, single blind clinical trial design was followed, to compare the efficacy of fluconazole in situ gel (0.5% w/v) with that of fluconazole tablets (100 mg) for 14 days. The patien
Sponsors
Nitte University (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of either sex, aged 18 or above 2. HIV-antibody seropositive or with partial or complete denture and the clinical picture of oropharyngeal candidiasis (OPC), which is characterised by creamy, white, curd like patches, removable erythematous lesions on the oral mucosal surfaces
Exclusion criteria
Exclusion criteria: 1. History of significant hepatic abnormalities or clinical evidence of significant hepatic diseases within 2 months of entering the study 2. Life expectancy of less than 1 month or a clinical condition such that study completion could not be assured 3. History of hypersensitivity to imidazole or azole compound 4. Patients requiring therapy with other antifungal agents, H2-receptor blockers, antacids, rifampicin, phenobarbital, pheytoin, carbamazeme, terfenadine, or astimazole 5. Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy parameter for clinical response was rated according to an evaluations assessment of the change in signs and symptoms from the baseline. The assessment was rated as "cured" (clearance of all signs and symptoms), "improved" (minimal signs and symptoms with no residual visible candida lesions), unchanged (no change in signs and symptoms), or "deteriorated" (worsening or increasing signs and symptoms). Patients with a clinical evaluation of "cured" or "improved" were considered as a successful outcome of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy parameters included the quantification in terms of CFUs of Candida spp. and results of culture from swabs taken at the same sites used at baseline. A mycological cure was defined as a yeast quantification of <10 CFU/ml based on comparison of mycological culture from swabs collected from healthy volunteers. To analyze the data of clinical efficacy statistically, a two-factor repeated measures analysis of variance was used between the treated groups over a period of 44 days. The criterion for significance was set at p<0.05. | — |
Countries
India
Outcome results
None listed