PURPOSE: To compare the clinical and bacteriological effects of fucidic acid (Fucithalmic: 1.0%) and chloramphenicol (Minims(R): 0.5%) eye drops in neonates with a clinical diagnosis of acute conjunctivitis of suspected bacterial origin. METHODS:A TOTAL OF 456 N: ewborns with gestational age > 32 weeks with acute conjunctivitis of suspected bacterial origin acquired within the first 28 days of life were included in the study. They were randomly assigned to a 7-day treatment with eye drops using either fucidic acid (1.0%) (Fucithalmic) applied twice per day, or chloramphenicol (0.5%) (Minims Chloramphenicol) applied six times per day. The subjects were followed up with two visits (on days 1 and 8) and by telephone 2 weeks after the end of treatment. RESULTS: Eighty-nine per cent of the neonates treated with Fucithalmic were cured, compared to 87.9% of those treated with Minims Chloramphenicol (n.s). The drug was used as instructed in 90.7% of patients treated with Fucithalmic and in 78.0% of those treated with Minims Chloramphenicol (P < 0.001). CONCLUSION: Treating neonatal conjunctivitis with fucidic acid is easier than with chloramphenicol and is equally effective.
RCT Entities:
PURPOSE: To compare the clinical and bacteriological effects of fucidic acid (Fucithalmic: 1.0%) and chloramphenicol (Minims(R): 0.5%) eye drops in neonates with a clinical diagnosis of acute conjunctivitis of suspected bacterial origin. METHODS: A TOTAL OF 456 N: ewborns with gestational age > 32 weeks with acute conjunctivitis of suspected bacterial origin acquired within the first 28 days of life were included in the study. They were randomly assigned to a 7-day treatment with eye drops using either fucidic acid (1.0%) (Fucithalmic) applied twice per day, or chloramphenicol (0.5%) (Minims Chloramphenicol) applied six times per day. The subjects were followed up with two visits (on days 1 and 8) and by telephone 2 weeks after the end of treatment. RESULTS: Eighty-nine per cent of the neonates treated with Fucithalmic were cured, compared to 87.9% of those treated with Minims Chloramphenicol (n.s). The drug was used as instructed in 90.7% of patients treated with Fucithalmic and in 78.0% of those treated with Minims Chloramphenicol (P < 0.001). CONCLUSION: Treating neonatal conjunctivitis with fucidic acid is easier than with chloramphenicol and is equally effective.