| Methods |
Participants were recruited from the outpatient clinic of the Institute of Pediatrics, University of Milan, Italy, between November 2000 and March 2002. The study group was identified as having a history of recurrent respiratory tract infections (≥ 8 episodes/year in < 3‐year olds or ≥ 6 episodes/year in ≥ 3‐year olds) and an acute lower or upper respiratory tract infection, as diagnosed by a paediatrician and recorded on a medical chart Exclusion criteria for the study group included acute streptococcal pharyngitis/acute otitis media/CAP at enrolment, severe concomitant disease, nosocomially acquired infection, topical/systemic steroid therapy in the 48 hours preceding study enrolment, systemic antibiotic treatment in the 48 hours preceding study enrolment, administration of azithromycin therapy in the week preceding study enrolment, and intramuscular administration of benzathine penicillin G in the month preceding study enrolment The control group were chosen from otherwise healthy participants undergoing minor surgical treatment during the study period. They were to be of a similar age and gender to the study group, without a history of respiratory tract infection or antibiotic treatment in the 3 months before enrolment Acute Mycoplasma pneumoniae (M. pneumoniae) infection, Chlamydia pneumoniae (C. pneumoniae) infection, or both was diagnosed if the child had a significant antibody response in paired sera or if the DNA of the bacteria was detected in nasopharyngeal aspirates, or both |
| Participants |
560 children, aged 1 to 14 years. 352 had acute respiratory infections and a history of recurrent respiratory tract infections (mean age = 3.6, 57.1% male, 136 with acute M. pneumoniae infection), and 208 were in the control group (mean age = 3.9, 57.2% male, 5 with acute M. pneumoniae infection) |
| Interventions |
Patients were randomised to receive azithromycin (n = 177, 10 mg/kg/day, 3 days/week for 3 weeks) with symptom‐specific agents (acetaminophen, 10 mg/kg per dose) or symptom‐specific agents alone (n = 175) |
| Outcomes |
Clinical presentations Bacteriological findings |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "All the patients were randomised in a blinded manner with a computerized list, by the only investigator responsible for randomisation"
Comment: randomisation was appropriate |
| Allocation concealment (selection bias) |
Low risk |
The enrolment officer was different to the investigator assigned to randomisation. Consequently, the enroller was unaware of which treatment group the participants would be allocated to |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Clinical outcome assessor blinded. Although patients and caregivers were not blinded, caregivers were "instructed not to inform the evaluator, who was blinded with respect to randomisation, whether the child had received azithromycin"
Quote: "Data entry and statistical analyses were carried out in a blinded manner, with SAS software"
Comment: raw data analyses were also blinded |
| Follow‐up?
All outcomes |
Low risk |
Quote: "All of the enrolled patients completed the 1‐month follow‐up evaluation"
Quote: "A total of 339 patients (96.3%) completed the 6‐month follow‐up evaluation"
Comment: a high proportion of participants were followed up |
| Reporting of participants by allocation group?
All outcomes |
Low risk |
The progress of all the children in both groups was described, although at 6 months 13 children were noted to be lost to follow‐up. The tables of results (both 1‐month and 6‐month follow‐ups) account for all available children |
