| Methods |
Open, randomised, multi centre controlled trial |
| Participants |
Inclusion criteria: ambulatory children with whooping cough and B. pertussis culture‐positive
Exclusion criteria: antimicrobial treatment during the 3 days before enrolment of patients, hypersensitivity to macrolide antibiotics, preexisting liver or renal disease, simultaneous treatment of theophylline or ergotamine, or body weight > 27.5 kg
The pertussis vaccination status was similar in both study groups. 115 patients (60.5%) had not been vaccinated at all (EST, 56 patients (60.2%); ETH, 59 patients (60.8)) |
| Interventions |
Treatment group: erythromycin estolate (EST) 40 mg/kg/day in 2 divided doses orally taken during meal for 14 days
Controlled group: erythromycin ethylsuccinate (ETH) 60 mg/kg/day in 3 divided doses orally taken during meals for 14 days |
| Outcomes |
Microbiological eradication, clinical assessment, decrease frequency and severity of cough, improved or cured general condition, adverse reactions, and patients' compliance measured by antimicrobial activity in the urine |
| Notes |
Immunisation status: the pertussis vaccination status was similar in both study groups. 115 patients (60.5%) had not been vaccinated at all (EST, 56 patient (60.2%); ETH, 59 patients (60.8)) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Method of randomisation: computer‐generated list of numbers |
| Allocation concealment (selection bias) |
Unclear risk |
Unclear risk |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Blinding of intervention: no. Blinding of outcome measure: no |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow up: yes |
