| Methods |
Randomised, parallel, double‐blind trial in which prophylactic efficacy of rimantadine against influenza A infection in children was evaluated. Rimantadine was compared to PB. The trial took place during a naturally occurring outbreak of influenza A (H3N2) in Oklahoma City, USA, from November, 1984 to March, 1985
Study duration: 5 weeks
Withdrawal: 3 children in the rimantadine group were found post‐study to have had documented influenza A infection before or on the day of institution of prophylaxis and were excluded from the analysis. 17 people from 5 families withdrew because of relocation or refusal to have a second blood specimen drawn. Their age group was not stated |
| Participants |
There was a total of 110 participants from 29 families, including 56 children, which was our subgroup of interest
Inclusion criteria: children within 29 families during a naturally occurring outbreak of influenza A infection
Exclusion criteria: if any family member was known to have cardiac, pulmonary or neurologic disease; if a female family member was pregnant or actively trying to become pregnant; if any family member had received the influenza vaccine during the past year; if any member was taking medications that might interfere with the study
Gender: both females and males were included (proportion not specified)
Disease stage: rimantadine was administered as a prophylactic when influenza A was identified within community |
| Interventions |
Rimantadine: 5 mg/kg/d, max: 100 mg/d (< 10 years) or 200 mg/d (> 10 years). Oral route |
| Outcomes |
Laboratory‐proven infection cases. Adverse effects |
| Notes |
1 to 18 years old |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Authors stated it was a "a randomised ... clinical trial" although randomisation methods are not described |
| Allocation concealment (selection bias) |
Unclear risk |
The authors state that their "study design has been previously reported" (Clover 1986) but even in that trial, the method of concealment is not clearly described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Reasons for missing outcome data unlikely to be related to outcome |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Authors stated it was "a double‐blind PB controlled clinical trial". Nevertheless, the specific people who are blinded are not listed |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Authors stated it was "a double‐blind PB controlled clinical trial". Nevertheless, the specific people who are blinded are not listed |
