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The Mycotic Ulcer Treatment Trial: A Randomized Trial Comparing Natamycin vs Voriconazole

The Mycotic Ulcer Treatment Trial: A Randomized Trial Comparing Natamycin vs Voriconazole

N Venkatesh Prajna, Tiruvengada Krishnan, Jeena Mascarenhas, Revathi Rajaraman, Lalitha Prajna, Muthiah Srinivasan, Anita Raghavan, Catherine E Oldenburg, Kathryn J Ray, Michael E Zegans, Stephen D McLeod, etc.

JAMA Ophthalmol. 2013 Apr;131(4):422-9.

PMID: 23710492

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

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP7681938-B	Natamycin		7681-93-8	Price

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