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. 2015 Mar 8;2015(3):CD001954. doi: 10.1002/14651858.CD001954.pub4

Ferwerda 2001.

Methods Location: The Netherlands
 Multicentre, randomised, double‐blind, double‐dummy study. Randomisation was done in blocks of 6 at a research centre. Blinding was maintained by matched placebo. Clinical evaluation was done on days 3 to 5, days 10 to 13 and days 25 to 30
Participants 118 participants aged 3 months to 12 years with community‐acquired lower respiratory tract infection were recruited. The diagnosis was based on the presence of respiratory signs and symptoms in combination with a positive chest radiograph or clinical evidence of a temperature 38 ºC or higher, cough, leucocytosis > 10,000 cells/mm³. Participants with symptoms for longer than 1 week, weight > 40 kg, or need for parenteral therapy were excluded. Azithromycin group N = 56, co‐amoxyclav group N = 54
Interventions 1. Azithromycin suspension 10 mg/kg/day single dose for 3 days
 2. Co‐amoxyclav suspension 45/11.25 mg/kg/day 3 times a day for 10 days
Outcomes Cure
 Improvement
 Failure
 Adverse events
Notes Of 118 randomised participants, 110 were clinically evaluated. 8 were excluded; 7 of them did not meet the inclusion criteria, and for 1 participant the informed consent was withdrawn. Compliance was measured by diary card, registered by parents
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done using blocks of 6 at Imro Tarmarko Berghem, The Netherlands
Allocation concealment (selection bias) Low risk Treatments were provided by the study sponsor in matched placebo suspensions. Randomisation was done using blocks of 6 at Imro Tarmarko Berghem, The Netherlands
Quote: "Patients were assigned randomly to treatment with oral azithromycin suspension (10 mg/kg/24 hours) in a single dose for 3 days or co‐amoxiclav suspension (45/11.25 mg/kg/24 h) tds for 10 days"
Blinding (performance bias and detection bias) 
 All outcomes Low risk Matched placebo suspensions were used in the 2 treatment groups. Each participant was equally treated for 13 days
Incomplete outcome data (attrition bias) 
 All outcomes Low risk At visit 3 (days 10 to 13) 1 patient was lost in each treatment group (azithromycin group N = 55, co‐amoxyclav N = 53)
Selective reporting (reporting bias) Unclear risk The study protocol is not available
Other bias Low risk Baseline characteristics were comparable between the 2 treatment groups