| Methods |
Patients were assigned treatment from a list of randomised therapy assignments
Concealment unclear
Unclear blinding status
No ITT analysis |
| Participants |
Age range: 2 months to 10.5 years
Both sexes
Pts who had suspected bacterial meningitis on the basis of identification of microbes on gram stained smear of CSF or proved bacterial meningitis were eligible for the study
However, patients with culture proved bacterial meningitis were enrolled and evaluated |
| Interventions |
Experimental arm: cefotaxime (50 mg/kg/dose i.v. 6 hrly for at least 10 days (mean duration 12.7 days)
Control arm: ampicillin (50 mg/kg/dose i.v. 6 hrly for first 5 days) and chloramphenicol (25 mg/kg/dose i.v. 6 hrly for 5 days followed by oral administration for at least 10 days). Mean duration of therapy in control group was 11.7 days |
| Outcomes |
Death
Sensory sequelae including visual auditory and co‐ordination problems
Inability to perform ADL
Developmental abnormalities
Duration of fever
Other sequelae
Duration of follow‐up: at least 4 months
Adverse effects noted in the experimental group were diarrhoea, thrombocytosis, neutropaenia, skin rash, prolonged fever, elevated ALT, elevated blood urea nitrogen and hyperkalaemia
Adverse effects noted in conventional therapy group were diarrhoea, neutropenia, prolonged fever and elevated ALT |
| Notes |
Study conducted in Costa Rica
16/42 in experimental arm and 18/43 in conventional therapy group had already received previous antibiotics
Neonates were initially included in the study but later excluded from analysis
Pts were evaluated for sequelae at the time of discharge and at the end of 4 months or longer |
| 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 |
Unclear risk |
The study did not address this |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Unclear risk |
Insufficient information |
