Phase 4
N=375
Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis
Bacterial Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT01540838 ↗Enrolled (actual)
375
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Day 7 Mortality — 61; 64 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Infusion with paracetamol (Drug); Bolus without paracetamol (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Helsinki
- Primary completion
- Feb 2017
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 | — |
Summary
The main purpose of this trial is to test if mortality of childhood bacterial meningitis can be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional bolus administration four times daily (qid), combined with high-dose paracetamol orally, when both treatments are executed for the first 4 days. The series will be collected at Hospital Pediátrico David Bernardino, Luanda, Angola.
The recruitment of patients begins, the conditions permitting, in early 2012. The criteria for patient participation is a child at the age of 2 months to 15 years who presents with the symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.
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). 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.