Del Rio 1983.
Methods | Random allocation, but method of randomisation and concealment not mentioned
Unclear blinding status No ITT analysis |
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Participants | Patients above 6 weeks of age (66/78 < 2 years). Patients with suspected or definite meningitis enrolled. Those with positive cultures and/or characteristic CSF findings were subsequently analysed. (Criteria for CSF findings not mentioned) | |
Interventions | Experimental arm: ceftriaxone (75 mg/kg i.v. loading dose followed by 50 mg/kg/dose i.v. 12 hrly) Control arm: ampicillin (200 mg/kg/day i.v. 6 hrly) and chloramphenicol (100 mg/kg/day i.v. 6 hrly) Duration of therapy: 7 days in both groups for meningococcal meningitis and 10 days for others | |
Outcomes | Death Sensorineural deafness (defined as > 30 dB hearing loss) Other disabilities Duration of fever Duration of follow‐up: 1 to 5 months Adverse effects noted in ceftriaxone group were diarrhoea, arthritis, phlebitis, raised SGOT and drug fever Adverse effects noted in conventional therapy group were diarrhoea, arthritis and drug fever | |
Notes | Study done in the USA 72/92 enrolled were culture positive | |
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 | Study did not address this |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | insufficient information |
Selective reporting (reporting bias) | Low risk | |
Other bias | Unclear risk | Insufficient information |