Methods |
Randomised, single‐blinded, controlled trial |
Participants |
88 children with isolated B. pertussis from nasopharynx or with a typical 'whooping' cough and a relative and absolute lymphocytosis
No account was taken of previous vaccination history
Exclusion criteria not stated
Tetracycline group N = 44 (55% male); 0 to 4 years: 22 males, 19 females; 5 to 10 years: 2 males, 1 female
Trimethoprim/sulphamethoxazole group N = 44 (36% male); 0 to 4 years: 15 males, 24 females; 5 to 10 years: 1 male, 4 females |
Interventions |
Treatment group: received tetracycline: children under 2 years old were given 62.5 mg tetracycline 6‐hourly and older children 125 mg 6‐hourly for 1 week
Control group received trimethoprim/sulphamethoxazole: children under 6 months old were given 20 mg trimethoprim with 100 mg sulphamethoxazole twice daily for one week; older children received double this dose
All children received phenobarbitone 15 mg t.d.s until vomiting and spasmodic cough had ceased, and were also given a simple linctus for use as required |
Outcomes |
Primary outcome: microbiological eradication of B. pertussis
Secondary outcome: clinical improvement after one week of treatment |
Notes |
Children were treated at home by their carers, who were asked to bring the children back after 1 week for assessment to the same doctor who saw the children at first attendance. This assessment was based on a full clinical examination, detailed history concerning cough, sleep pattern, vomiting, feeding and general behaviour. Pernasal swabs were taken on first and second attendance
Out of 88 patients only 66 returned for follow up. Missed (dropout) patients = 22 (25%). Immunisation status not stated |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Method of randomisation: not stated |
Allocation concealment (selection bias) |
Unclear risk |
Unclear risk |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Blinding of intervention: unclear. Blinding of outcome measure: yes |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Complete follow up: no |