| Methods |
Participants were randomised in a 2:1 ratio to receive either azithromycin or amoxycillin/clavulanic acid. No blinding. Efficacy was evaluated at 8 to 10 days after the therapy started |
| Participants |
759 adult participants aged between 18 to 75 years were recruited; 620 had acute tracheobronchitis and 139 had acute exacerbations of chronic bronchitis. A diagnosis of acute tracheobronchitis was based on the presence of at least 2 of the following signs and symptoms: cough, fever 38 ºC or higher, purulent sputum and rhonchi/rales. Participants: azithromycin group N = 501, amoxycillin/clavulanic acid group N = 258 |
| Interventions |
1. Azithromycin 500 mg once daily for 3 days (2 x 250 mg capsules taken at least 1 hour before or 2 hours after meals)
2. Amoxicillin/clavulanic acid 625 mg (amoxycillin 500 mg + clavulanate 125 mg) 3 times daily for 5 to 10 days, taken during or shortly after meals |
| Outcomes |
Cure
Improvement
Failure
Adverse events |
| Notes |
Of 759 participants, 31 participants with various reasons (adverse events, lack of efficacy and lost to follow‐up) discontinued treatment; 9 in the azithromycin group and 22 in the amoxycillin/clavulanate group. 26 out of 31 who dropped out were followed and evaluated. In the analysis, 754 participants were included |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information. Quote: "Patients were randomized in a 2:1 ratio to receive either azithromycin or amoxicillin/clavulanic acid" |
| Allocation concealment (selection bias) |
Unclear risk |
The method of allocation was not described |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
No blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
754 participants (99%; 754/759) were included in the analysis |
| Selective reporting (reporting bias) |
Unclear risk |
Information not available |
| Other bias |
Unclear risk |
Baseline characteristics of the 2 treatment groups were not addressed |
