| Methods |
Participants were recruited from emergency departments in Dallas and Panama with a diagnosis of CAP for the period February 1996 to December 1997 Inclusion criteria were tachypnoea, fever, cough, crackles and chest X‐ray with changes compatible with pneumonia Exclusion criteria were hypersensitivity to macrolides or beta‐lactam antibiotics, pregnancy, nosocomial pneumonia, use of systemic antibiotics 72 hours prior to recruitment, chronic illness such as HIV, malignancy, cystic fibrosis, haematologic, renal, cardiovascular, hepatic or pulmonary diseases, as well as patients on teofilin, antihistamines, steroids or any medications with potential interaction with macrolides Study participants were randomised to azithromycin or either amoxycillin‐clavulanate if under 5 years and erythromycin if over 5 years. A random number list was used and therapy assigned by pharmacy. The study was not blinded. There were 39 drop‐outs, although reasons were not specified. There was no assessment of compliance Clinical outcomes were evaluated on days 2 to 3 and 10 to 25 Baseline measurements were recorded using blood cultures, nasopharyngeal aspirate cultures and PCR for M. pneumoniae and C. pneumoniae. Antibody titres against the 2 micro‐organisms were evaluated using serology. Additionally, full blood examination, urea and electrolytes, liver function tests and tuberculin tests were used to assess infection. Clinical response was evaluated as a cure or fail, and clinical cure was defined as complete resolution or evident improvement of all clinical signs and symptoms. Clinical failure was defined as persistent or progressive symptoms after 3 days of treatment |
| Participants |
Total of 335 children aged 6 months to 15 years with CAP; 168 from Dallas with 106 under 5 years (males = 92) and 167 from Panama with 142 under 5 years (males = 98) 39 children dropped out. The number of children with M. pneumoniae infection in each group was not stated |
| Interventions |
Group A: azithromycin 10 mg/kg on day 1 and 5 mg/kg OD for days 2 to 5 Group B: amoxycillin‐clavulanate 40 mg/kg/day, TID for 10 days if under 5 years and erythromycin 40 mg/kg/day, TID for 10 days if over 5 years |
| Outcomes |
Clinical presentations Bacteriological findings Adverse events |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
List of randomised numbers assigned to therapy. Unclear how randomised numbers were generated but medication given by pharmacy |
| Allocation concealment (selection bias) |
Low risk |
Medications provided by pharmacy |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
No blinding of outcome assessor |
| Follow‐up?
All outcomes |
Unclear risk |
30 drop‐outs but no description of withdrawals or drop‐outs were provided in accordance to groups |
| Reporting of participants by allocation group?
All outcomes |
Unclear risk |
No mention of withdrawals or drop‐outs relative to allocated groups |
