Methods |
Multicentre study, participants were randomised to receive either azithromycin or amoxycillin/clavulanic acid. No blinding. Efficacy was evaluated 10 days after the therapy started |
Participants |
142 hospitalised or outpatients aged 18 years or more with acute purulent exacerbation of chronic bronchitis. Exclusion criteria: participants treated with other antibiotics 48 hours prior to the study, leucopenia, coagulation disorders, renal dysfunction, HIV/AIDS on immunosuppressive drugs, suspected pneumonia with lung abscess, pleuritis, empyema or active tuberculosis, pregnancy and lactation. Participants: azithromycin group N = 69, amoxycillin/clavulanic acid group N = 73 |
Interventions |
1. Azithromycin (Pfizer) 500 mg single dose daily for 3 days
2. Amoxycillin/clavulanic acid SmithKline Beecham (amoxycillin 875 mg + clavulanic acid 125 mg) twice daily for 8 days |
Outcomes |
Cure (disappearance of all signs and clinical symptoms of infection by day 10)
Improvement (disappearance of only a few signs and/or clinical symptoms)
Failure (persistence or worsening of signs and symptoms at days 4 and 10) |
Notes |
Corticosteroids were allowed, provided this did not exceed 25 mg for prednisolone or its equivalent in both groups. Of the 142 participants, 2 participants dropped out and were not included in the analysis |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
High risk |
The method of randomisation was not reported |
Allocation concealment (selection bias) |
High risk |
Not mentioned in the article |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
No blinding |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All participants randomised were analysed. 69 in the azithromycin group and 73 in the amoxycillin group |
Selective reporting (reporting bias) |
Unclear risk |
Information not available |
Other bias |
Unclear risk |
Baseline characteristics of the 2 treatment groups were not addressed |