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Bacterial Meningitis | Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis

Bacterial Meningitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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 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: 1. Trauma, or relevant underlying illness such as intracranial shunt, previous neurological abnormality (cerebral palsy, Down's syndrome, meningitis) 2. Previous hearing impairment (if known) 3. Immunosuppression, except HIV infection 4. More than one parenteral dose of a pretreatment antimicrobial. Children with oral antimicrobials are included, this information being marked in the FOLLOW-UP sheet. 5. Active tuberculosis (if tuberculotic meningitis is diagnosed during trial, it will be included in intention-to-treat (ITT) analysis) 6. Known hepatic disease.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bacterial Meningitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Infusion with paracetamolThe administration of 250 mg/kg/24 hours cefotaxime during the first 4 days as continuous intravenous infusion, each single infusion lasting for 12 hours (to prevent degradation of the agent), combined with high-dose paracetamol orally; the first dose is 30 mg/kg, then 20 mg/kg every 6 hours for 4 full days.

Drug:Bolus without paracetamolThe control intervention consists of 250 mg/kg/24 hours cefotaxime administered traditionally with intermittent i.v. boluses and the place bo of paracetamol orally, both repeated every 6 hours (qid) for 4 days.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Infusion with paracetamolCefotaxime is administered as 12 hourly infusions, together with high dose paracetamol (acetaminophen)

Bolus with placeboCefotaxime is administered as bolus q.i.d. with a placebo of paracetamol

Study Status

Completed

Start Date: February 2012

Completed Date: February 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Mortality

Secondary Outcome: Mortality

Study sponsors, principal investigator, and references

Principal Investigator: Heikki O Peltola, MD, PhD

Lead Sponsor: Helsinki University

Collaborator: Foundation for Paediatric Research, Finland

More information:https://clinicaltrials.gov/show/NCT01540838

Pelkonen T, Roine I, Cruzeiro ML, Pitkäranta A, Kataja M, Peltola H. Slow initial β-lactam infusion and oral paracetamol to treat childhood bacterial meningitis: a randomised, controlled trial. Lancet Infect Dis. 2011 Aug;11(8):613-21. doi: 10.1016/S1473-3099(11)70055-X. Epub 2011 May 5.

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