| Methods |
Allocation using computer‐generated list and sealed envelopes |
| Participants |
Age: median age 7 years (all patients > 2 months)
Both sexes
Patients who had suspected meningitis on the basis of fever in last 24 hrs/ sudden onset of fever along with at least one of the following: neck stiffness, impaired consciousness, or petechial rash (> 1 yr); or bulging fontanel, axial hypotonia, upwardly gazing or petechial rash (< 1 year) |
| Interventions |
Experimental arm : ceftriaxone (100 mg/kg/day i.m. up to a maximum dose of 4 g; 2nd dose of 75 mg/kg at 24 to 48 hrs. In case of clinical failure. Control arm: oily suspension of chloramphenicol (100 mg/kg/day i.m. up to a max. dose of 3 g; 2nd dose of 100 mg/kg in case of clinical failure at 24 to 48 hrs |
| Outcomes |
Death
Overall treatment failure (death or clinical failure at 72 h defined as state of consciousness remaining severely altered, no improvement in the state of consciousness since 0 hrs, repeated or persistent convulsions, worsened neurological symptoms since 0 hrs, axillary temperature > 38.5C)
Neurological sequelae at 72 h |
| Notes |
Study done in eastern Niger for 1 month during a meningitis epidemic |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
|
| Allocation concealment (selection bias) |
Low risk |
|
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Study did not address this |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Low risk |
|
