| Methods |
Randomised, single‐blinded (investigator) controlled trial |
| Participants |
Inclusion criteria: children aged 1 month to 16 years with clinical pertussis
Exclusion criteria: the presence of a cough for 21 days or longer, treatment with any antibiotic with known activity against B. pertussis, concomitant therapy with terfenadine, astemizole or zidovudine, concomitant therapy with theophylline, digitalis glycoside, ergotamine, carbamazepine, phenytoin, warfarin therapy, known allergy to macrolide antibiotics, presence of a disease requiring the use of steroid medications, presence of underlying cardiac, hepatic, bronchopulmonary, renal, immunodeficiency, malabsorption disorder or pregnancy
Immunisation status: pertussis vaccination: (%) in treatment group = 89, control group = 90 |
| Interventions |
Treatment group: clarithromycin granules for suspension 7.5 mg/kg/dose twice daily (maximum dose 500 mg twice daily) orally for 7 days
Control group: erythromycin estolate 13.3 mg/kg/dose (maximum dose, 333 mg 3 times a day) orally for 14 days |
| Outcomes |
Microbiological eradication, clinical cure, adverse reactions, complications (otitis media) and compliance to medications |
| Notes |
The study populations considered in the analysis: the per protocol population included those patients who had a positive culture for B. pertussis at baseline and
a. received study drug for a minimum 3 days
b. had a post‐treatment culture and clinical assessment
c. did not take any interfering concomitant antimicrobial therapy, and
d. did not violate the study protocol
Immunisation status: pertussis vaccination treatment group = 89%, control group = 90% |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Method of randomisation: computer‐generated random list |
| Allocation concealment (selection bias) |
Low risk |
Low risk |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of intervention: yes. Blinding of outcome measure: yes |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete follow up: yes |
