| Methods |
Location: The Netherlands, multicentre study
Participants were randomly assigned to treatment. Single‐blinding was performed. All 99 randomised participants were clinically evaluated on days 3 to 7 and days 12 to 16 |
| Participants |
99 outpatients from 4 centres in The Netherlands, with clinical evidence of lower respiratory tract infection, either pneumonia or purulent bronchitis or acute exacerbation of chronic bronchitis, were recruited. Participants with a terminal illness, concomitant use of other antibiotics, or with infectious mononucleosis, cystic fibrosis and gastrointestinal absorption abnormality were excluded. Azithromycin group N = 48, co‐amoxyclav group N = 51 |
| Interventions |
1. Azithromycin 500 mg once daily for 3 days
2. Co‐amoxyclav 625 mg 3 times a day for 10 days |
| Outcomes |
Cure
Improvement
Failure
Adverse events
Eradication of pathogen |
| Notes |
Medication (bronchodilators, adrenergic stimulators or corticosteroids) was given in addition to the study drug to 83% of participants in the azithromycin group and 82% in the co‐amoxyclav group. Compliance was measured by pill count. All 99 randomised participants were evaluated for clinical efficacy |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was performed by the Department of Pharmacy at the University Hospital, Utrecht |
| Allocation concealment (selection bias) |
High risk |
The information about concealment is not provided. Quote: "Patients were randomized to receive either azithromycin as a once‐daily dose of 500 mg (two 250 mg capsules) for three days, or co‐amoxiclav (625 mg capsules) tid for ten days. Randomization was performed by the Department of Pharmacy at the University Hospital, Utrecht." |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Quote: "We report the results of a single‐blind comparison of azithromycin with a ten‐day course of coamoxiclav (amoxycillin/clavulanic acid) in patients with acute lower respiratory tract infections". However, it is not clear to whom the single‐blind was applied and no information was available |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Analysis of clinical efficacy was performed using data provided from a total of 99 randomised participants |
| Selective reporting (reporting bias) |
Unclear risk |
The study protocol is not available |
| Other bias |
Unclear risk |
Baseline characteristics of the 2 treatment groups were not available. However, the authors mentioned that "The two treatment groups were comparable with respect to age, sex ratio, and underlying diseases (not shown)" |
