Bacterial Meningitis Clinical Trial
Official title:
Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis, Especially of Pneumococcal Meningitis, in Angola.
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.
The principal objective of the study is to examine if mortality of childhood bacterial
meningitis can be reduced by slow continuous infusion of cefotaxime combined with high-dose
paracetamol orally for the first 4 days (instead of the traditional qid administration of
cefotaxime without concomitant paracetamol). Children qualifying for entry (see criteria
below), whose guardian has given informed consent,will be randomized into 2 treatment arms
(see details below)and receive the treatments in a double blind fashion (see details below).
Primary and secondary outcomes (detailed below) will be evaluated according to predefined
criteria and time points (see below).
Results will be analyzed for all patients in ITT datasets and in prespecified subgroups
(etiology, nutritional status, etc.) in both crude and adjusted analysis. The efficacy
results will be expressed as OR with 95% confidence intervals.
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