| Methods |
Participants with a diagnosis of CAP were recruited from 1 January 1996 to 1 January 1999 Inclusion criteria were children with a clinical diagnosis of radiologically confirmed of presumed bacterial CAP, eligible for treatment with oral antibiotics and without signs of respiratory insufficiency Exclusion criteria were history or evidence of chronic pathology of any organ system, chronic pulmonary disease, history of prematurity, treatment with any antibiotics within 5 days prior to enrolment, or known hypersensitivity to beta‐lactam antibiotics or macrolides The study population was divided into 2 groups according to clinical and radiological patterns. One group included those children who presented with signs of classic bacterial pneumonia, with high fever and chest findings of crackles or signs of consolidation, and chest X‐rays with segmental, alveolar or lobar consolidation. The second group included patients with atypical pneumonia, with prominent and frequently paroxysmal cough, variable fever, few clinical signs of consolidation, crackles and wheezing, and chest X‐rays with a mixed alveolar‐interstitial pattern Participants with classic pneumonia were randomised to either amoxycillin or azithromycin, whereas participants in the atypical pneumonia group were randomly assigned to either azithromycin or erythromycin. The method of randomisation was not described. There was no mention of blinding except for blinding of the radiologist who viewed follow‐up chest X‐rays done on study days 7 and 14. There was a description of withdrawals or drop‐outs. There was no assessment of compliance Outcomes were evaluated at 3 clinic visits, on study days 3, 7 and 14. A chest X‐ray was done for each child on study days 7 and 14. Evidence of infection was determined by indirect immunofluorescence and enzyme‐linked immunosorbent assay to test sera for IgM antibodies to M. pneumoniae. An antibody titre > 1:16 on a single first serum specimen was considered positive for indirect immunofluorescence. Clinical response in the classic pneumonia group was defined as the proportion of children without fever on day 3 and/or improvement of more than 75% of radiographic baseline findings on study day 7 |
| Participants |
110 children aged 1 month to 14 years were enrolled 4 children developed serious pneumonia in the first 12 hours of enrolment and were excluded from the study (3 from the atypical group and 1 from the classic group). The remaining 106 completed the study The mean age was 4.9 years and 53 were male 47 met the criteria for classic pneumonia. The number of children with M. pneumoniae in the classic group was 8, with 5 in the azithromycin group and 3 in the amoxycillin‐clavulanate group |
| Interventions |
Patients with classic pneumonia:
|
| Outcomes |
Clinical presentations Radiological findings |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The method of randomisation was not specified |
| Allocation concealment (selection bias) |
Unclear risk |
Methods of allocation concealment were not identified |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Almost no methods of blinding were specified. Participants and caregivers may have been aware of their treatment group, as the frequency and duration of drug administrations were different between the groups
Quote: "All chest X‐rays done ... were seen by the same radiologist, who was not familiar with the patients' clinical history and treatment group"
Comment: radiology assessment was blinded |
| Follow‐up?
All outcomes |
Low risk |
Quote: "Of the 110 enrolled patients, 4 children developed severe pneumonia in the first 12 hr of enrolment and were excluded from the study... The remaining 106 children completed the study"
Comment: no participants were lost to follow‐up |
| Reporting of participants by allocation group?
All outcomes |
Low risk |
The progress of all randomised children in each group was described. Results tables compared outcomes between groups |
