Methods |
Randomised, double‐blinded, controlled trial |
Participants |
Inclusion criteria: children 0 to 5 years of age admitted to the 8 hospitals with uncomplicated clinical pertussis within 21 days after the onset of the earliest symptoms were included in the study
Exclusion criteria children with complicated pertussis |
Interventions |
Treatment group:
Group 1: Aureomycin (chlortetracycline) 0 to 11 months: 1 g daily, 12 to 35 months: 1.5 g and children aged 36 to 59 months 2 g daily in 2 divided doses daily for 7 days
Second group: chloramphenicol doses are given in similar doses as in Aureomycin for 7 days
Control group: children were given a mixture of lactose and quinine |
Outcomes |
1. Mortality rate
2. Respiratory complications
3. All side effects
4. Bacteriological eradication: cannot be assessed for each group
5. Clinical assessment cannot be assessment for each group |
Notes |
On admission the patients were divided by sex and placed in one of 3 age groups 0 to 11 months, 12 to 35 months, and 36 to 59 months, then they were allocated to one of the 3 treatment groups by a randomly determined sequence. Immunisation status: not stated |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Method of randomisation: randomly determined sequence |
Allocation concealment (selection bias) |
Unclear risk |
Unclear risk |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Blinding of intervention: yes. Blinding of outcome measure: yes. Double‐blinded trial |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Complete follow up: no |