| Methods |
Random allocation but method of randomisation and concealment not mentioned
Single blinding mentioned but method of blinding not clear
No ITT analysis |
| Participants |
Age range: 1 month to 9 years
Both sexes
Diagnosed bacterial meningitis on the basis of Gram stain of CSF and/or CSF culture |
| Interventions |
Experimental arm: cefotaxime (100 to 200 mg/kg/d i.v. for initial 3 to 5 days followed by i.m. for the rest of the duration in 2 or 3 divided doses)
Control arm: penicillin G (0.5 ‐ 1 million I.U. 6 hourly i.v. for initial 3 to 5 days followed by i.m. for the rest of the duration) and chloramphenicol (80 to 100 mg/kg/day orally in 3 to 4 divided doses)
Sulphadiazine (100 mg/kg/day orally) was also given to 8/15 analysed in the control arm |
| Outcomes |
Death
Sensorineural deafness
Other disabilities
Duration of fever
Mean duration of follow‐up: 27.1 months
Adverse effects noted in cefotaxime group were diarrhoea, neutropenia, anaemia and thrombocytosis
Adverse effects noted in conventional therapy group were all the above plus thrombocytopaenia |
| Notes |
Study conducted in South Africa
Sulfadiazine used in first 18 months of 52 month‐long trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information about the sequence generation process |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
|
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Unclear risk |
Insufficient information |
