Dettagli per singolo studio

DEC-NET Serial number GB416

Published online	31/05/2005 14.50.00
Last updated	13/03/2006 11.16.47


This trial has been approved by an ethics committee
Current trial status	Published in public domain
First subject enrolment Target N. of subjects	10/2002 340
Major Disease (ICD9 class)	ACUTE CONJUNCTIVITIS UNSPECIFIED
Experimental drug
CHLORAMPHENICOL Treatment regimen (dosage and duration) 4 hourly for a maximum of 7 days
Gender	Both
Age (range)	6months to 10 years
Eligibility criteria
Inclusion criteria
Young children with acute infective conjunctivitis
Exclusion criteria
Children whose parents refuse informed consent consent
Trial design/methodology
Phase	2
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
To estimate the effect of topical antibiotic treatment in children with acute infective conjunctivitis recruited from UK general practice
Primary outcomes
1. Proportion of children without symptons at 7 days 2. Proportion of children with microbiological cure at 7 days
Secondary outcomes
1. Median time to cure of symptoms 2. Recurrence of symptons within three months
Summary of study design, objectives, and ongoing research findings
A randomised double-blind trial to compare the effectiveness of chloramphenicol eye drops with placebo in children with infective conjunctivitis in primary care. 326 children aged 6 months to 12 years with a clinical diagnosis of conjunctivitis were recruited from 12 general medical practices in the UK. 163 children were assigned chloramphenicol eye drops and 163 placebo eye drops. Eye swabs were taken for bacterial and viral analysis. The primary outcome was clinical cure at day 7; this was assessed from diaries completed by parents. All children were followed up for 6 weeks to identify relapse. Survival statistics were used for comparison, and analysis was by intention to treat. Findings Nine children were lost to follow-up (one in chloramphenicol group; eight in placebo group). Clinical cure by day 7 occurred in 128 (83%) of 155 children with placebo compared with 140 (86%) of 162 with chloramphenicol (risk difference 3·8%, 95% CI −4·1% to 11·8%). Seven (4%) children with chloramphenicol and five (3%) with placebo had further conjunctivitis episodes within 6 weeks (1·2%, −2·9% to 5·3%). Adverse events were rare and evenly distributed between each group. Interpretation Most children presenting with acute infective conjunctivitis in primary care will get better by themselves and do not need treatment with an antibiotic.