| Methods |
Location: USA, multicentre study
Participants were randomly assigned to treatment. Investigator‐blinded, parallel‐group study. Clinical evaluation was performed at 3 visits, days 5 to 7, days 11 to 14 and days 26 to 30 |
| Participants |
70 outpatients aged between 35 and 75 years with a clinical diagnosis of acute bacterial exacerbation of chronic bronchitis were recruited. Participants with pneumonia, bronchitis with concurrent bronchiectasis or active bronchial asthma, or use of antibiotics within 72 hours of enrolment were excluded. Participants: azithromycin group N = 39, amoxycillin/clavulanate group N = 31 |
| Interventions |
1. Azithromycin 500 mg once on day 1, followed by 250 mg daily on days 2 to 5
2. Amoxycillin/clavulanate 500 mg 3 times a day for 10 days |
| Outcomes |
Cure (complete resolution of resolution of acute exacerbation of COPD on day 11)
Improvement (incomplete resolution)
Failure
Relapse (day 28)
Adverse events
Eradication of pathogen (day 11)
Recurrence of pathogen (day 28) |
| Notes |
14 participants were excluded from clinical outcome analysis; 8 of 14 had a resistant pathogen (azithromycin 6, amoxycillin/clavulanate 2), 6 had protocol violations (azithromycin 4, amoxycillin/clavulanate 2). Bacteriologic evaluation was performed in 37 participants who had baseline pathogen reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information was available |
| Allocation concealment (selection bias) |
Unclear risk |
Quote: "Patients were randomly assigned to receive either azithromycin once daily (two 250‐mg capsules together on day 1, followed by one 250‐mg capsule a day on days 2 through 5) or amoxicillin/clavulanate three times daily (one 500‐mg tablet three times a day for 10 days)" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quote: "To maintain investigator blinded conditions, study medication was assigned and dispensed by an individual other than the investigator responsible for clinical assessments" |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
25.6% (10/39) of the azithromycin group and 12.9% (4/31) of the amoxycillin/clavulanate group were excluded from evaluation of clinical response at the day 11 end of therapy visit with the reasons explained in the paper: isolation of a resistant pathogen at baseline (6 azithromycin; 2 amoxycillin/clavulanate) or miscellaneous protocol violations, including failure to meet the inclusion criteria, concurrent treatment with another antibiotic, irregular visits or loss to follow‐up (4 azithromycin, 2 amoxycillin/clavulanate) |
| Selective reporting (reporting bias) |
Unclear risk |
The study protocol is not available |
| Other bias |
Low risk |
Baseline characteristics were comparable between the 2 treatment groups |
