| Methods |
Randomised, parallel, double‐blind comparison of rimantadine with PB. The trial took place during an outbreak of influenza A/H1N1 in Oklahoma
Study duration: 5 weeks
Patients and providers were blinded. Outcome assessor method of blinding was unclear
Dropouts: 3 families who moved outside the study area, 1 in the placebo group whose parents attributed the 'medication' to the reducing of the child's performance at school and 1 in the rimantadine group due to a non‐influenza illness in a 4‐year‐old child
Co‐interventions and other potential confounders were not observed |
| Participants |
There was a total of 146 participants, including 76 children, which was our subgroup of interest
Inclusion criteria: children within 35 families during a naturally occurring outbreak of influenza A
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. Duration: 5 weeks |
| Outcomes |
Laboratory‐proven infection cases and reported adverse effects |
| Notes |
1 to 18 years old |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
It is reported that "children ... received either rimantadine or PB in a double‐blind, random assignment". Nevertheless, the randomisation method is not described |
| Allocation concealment (selection bias) |
Unclear risk |
Concealment is not clearly described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Reasons for missing outcome data are unlikely to be related to true outcome |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
It is stated that "children ... received either rimantadine or PB in a double‐blind, random assignment" but the specific people who were blinded are not listed |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
It is stated that "children ... received either rimantadine or PB in a double‐blind, random assignment" but the specific people who were blinded are not listed |
