Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis
Source: ClinicalTrials.gov NCT01540838 ↗Summary
Linked Publications (2)
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Extended Continuous β-Lactam Infusion With Oral Acetaminophen in Childhood Bacterial Meningitis: A Randomized, Double-blind Clinical Trial.
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Prevalence and significance of anaemia in childhood bacterial meningitis: a secondary analysis of prospectively collected data from clinical trials in Finland, Latin America and Angola.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Day 7 Mortality |
61; 64 | — |
| SECONDARY All Deaths During Hospital Stay |
71; 75 | — |
| SECONDARY Status on the Modified Glasgow Outcome Scale |
5; 5 | — |
| SECONDARY Death or Any Neurological Sequelae on Day 7 |
96; 86 | — |
| SECONDARY A Change in Hearing Threshold Compared to the First Test Result |
0; 0 | — |
| SECONDARY Death or Severe Neurological Sequelae on Day 7 |
80; 75 | — |
| SECONDARY Number of Participants With Deafness |
3; 1 | — |
| SECONDARY Death or Any Neurological Sequelae at Discharge From Hospital. |
104; 89 | — |
| SECONDARY Death or Severe Neurological Sequelae at Discharge |
90; 85 | — |
Eligibility Criteria
Eligibility criteria:
The study entry is assessed for all children at age 2 months - 15 years who present at these centers with the symptoms and signs suggestive of bacterial meningitis (BM), and to whom lumbar puncture is performed.
Inclusion criteria
All patients whose cerebrospinal fluid (CSF) turns out to be cloudy, positive by Gram staining or latex agglutination, or shows at least 50 leukocytes per mm3, will be enrolled in the study.
Participants: Exclusion criteria
Exclusion criteria
- Trauma, or relevant underlying illness such as intracranial shunt, previous neurological abnormality (cerebral palsy, Down's syndrome, meningitis)
- Previous hearing impairment (if known)
- Immunosuppression, except HIV infection
- More than one parenteral dose of a pretreatment antimicrobial. Children with oral antimicrobials are included, this information being marked in the FOLLOW-UP sheet.
- Active tuberculosis (if tuberculotic meningitis is diagnosed during trial, it will be included in intention-to-treat (ITT) analysis)
- Known hepatic disease.
Data sourced from ClinicalTrials.gov (NCT01540838) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.