Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial

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dc.contributor.authorHoffman, Jeremy John
dc.contributor.authorYadav, Reena
dc.contributor.authorDas Sanyam, Sandip
dc.contributor.authorChaudhary, Pankaj
dc.contributor.authorRoshan, Abhishek
dc.contributor.authorKumar Singh, Sanjay
dc.contributor.authorArunga, Simon
dc.contributor.authorMatayan, Einoti
dc.contributor.authorMacleod, David
dc.contributor.authorAnne Weiss, Helen
dc.contributor.authorLeck, Astrid
dc.contributor.authorHu, Victor
dc.contributor.authorBurton, Matthew J.
dc.date.accessioned2023-03-28T17:31:37Z
dc.date.available2023-03-28T17:31:37Z
dc.date.issued2020
dc.description.abstractFungal infections of the cornea, fungal keratitis (FK), are challenging to treat. Current topical antifungals are not always effective and are often unavailable, particularly in low-income and middle-income countries where most cases occur. Topical natamycin 5% is usually first-line treatment, however, even when treated intensively, infections may progress to perforation of the eye in around a quarter of cases. Alternative antifungal medications are needed to treat this blinding disease. Chlorhexidine is an antiseptic agent with antibacterial and antifungal properties. Previous pilot studies suggest that topical chlorhexidine 0.2% compares favourably with topical natamycin. Full-scale randomised controlled trials (RCTs) of topical chlorhexidine 0.2% are warranted to answer this question definitively. Methods and analysis We will test the hypothesis that topical chlorhexidine 0.2% is non-inferior to topical natamycin 5% in a two-arm, single-masked RCT. Participants are adults with FK presenting to a tertiary ophthalmic hospital in Nepal. Baseline assessment includes history, examination, photography, in vivo confocal microscopy and cornea scrapes for microbiology. Participants will be randomised to alternative topical antifungal treatments (topical chlorhexidine 0.2% and topical natamycin 5%; 1:1 ratio, 2–6 random block size). Patients are reviewed at day 2, day 7 (with reculture), day 14, day 21, month 2 and month 3. The primary outcome is the best spectacle corrected visual acuity (BSCVA) at 3 months. Primary analysis (intention to treat) will be by linear regression, with treatment arm and baseline BSCVA prespecified covariates. Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty (corneal transplant), positive reculture rate (day 7) and quality of life (EuroQol-5 dimensions, WHO/ PBD-VF20, WHOQOL-BREF). Ethics and dissemination The Nepal Health Research Council, the Nepal Department of Drug Administration and the London School of Hygiene and Tropical Medicine ethics committee have approved the trial. The resultsen_US
dc.identifier.citationHoffman JJ, Yadav R, Das Sanyam S, et al. Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial. BMJ Open 2020;10:e038066. doi:10.1136/ bmjopen-2020-038066en_US
dc.identifier.uri10.1136/ bmjopen-2020-038066
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/8319
dc.language.isoenen_US
dc.publisherBMJ openen_US
dc.subjectTopical chlorhexidineen_US
dc.subjectTopical natamycinen_US
dc.subjectFungal keratitisen_US
dc.titleTopical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trialen_US
dc.typeArticleen_US
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