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8 were excluded; 7 of them did not meet the inclusion criteria, and for 1 participant the informed consent was withdrawn.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 |