alexa The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.
Genetics & Molecular Biology

Genetics & Molecular Biology

Fungal Genomics & Biology

Author(s): Prajna NV, Krishnan T, Mascarenhas J, Rajaraman R, Prajna L,

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Abstract OBJECTIVE: To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. METHODS: This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1\%) or natamycin (5\%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. MAIN OUTCOME MEASURES: The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. RESULTS: A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40\%]), Aspergillus (54 patients [17\%]), and other filamentous fungi (141 patients [43\%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95\% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95\% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95\% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95\% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95\% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95\% CI, 0.48 to 2.43; P=.86). CONCLUSIONS: Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. APPLICATION TO CLINICAL PRACTICE: Voriconazole should not be used as monotherapy in filamentous keratitis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00996736
This article was published in JAMA Ophthalmol and referenced in Fungal Genomics & Biology

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