Murray 1997.
Methods | Multicentre, open‐label study. Location of study: USA Loss to follow‐up: unclear Analysis: no ITT |
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Participants | Inclusion criteria: immunocompromised ‐ HIV and other causes; >13 yrs; clinical and mycological confirmed OPC Exclusion criteria: presence of perioral lesions only, signs and symptoms suggestive of esophageal candidiasis, history of hepatic abnormalities, or clinical evidence of hepatic disease within 2 months of entering the study, life expectancy of < 1 month, history of hypersensitivity to imidazole or azole compounds, patients requiring therapy with histamine2‐receptor antagonists, antacids, rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, terfenadine, astemizole. 162 enrolled 123 HIV/AIDS ‐ Itraconazole group = 61 ‐ Clotrimazole group = 62 Diagnosis confirmed: yes ‐ culture |
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Interventions | Itraconazole oral solution: once each day two 10mL aliquots of solution were to be swished vigorously in the mouth for several seconds and then swallowed Clotrimazole troches: 5 troches taken daily, each dissolved slowly in the mouth. Duration: 14 days. If clinical response to treatment at day 14 then observed for another month |
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Outcomes | Primary: Clinical cure judged on symptoms, extent of oral lesions and culture. Cured (clearance of symptoms), improved (minimal symptoms remaining with no residual visible lesions), unchanged or deteriorated. Secondary: recurrence of other fungal infections Adverse events: GIT symptoms mainly. 7 patients in itraconazole group and 3 in clotrimazole group had to discontinue study participation prematurely as a result of adverse events. |
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Notes | Ethics: approval obtained from each clinical centre IRB; written informed consent | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Method how generated not stated |
Allocation concealment? | High risk | Not reported |
Blinding? All outcomes | High risk | Investigator assessing the outcome was blinded. |
Incomplete outcome data addressed? All outcomes | High risk | Loss to follow‐up unclear. No ITT |