Clinical Trials Directory

Trials / Completed

CompletedNCT00167713

Treatment of Fever Due to Malaria With Ibuprofen

Randomised, Double-Blind, Placebo Controlled Study of the Antipyretic Effect of Ibuprofen in Children With Uncomplicated Malaria

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
50 (planned)
Sponsor
Albert Schweitzer Hospital · Academic / Other
Sex
All
Age
2 Years – 7 Years
Healthy volunteers
Not accepted

Summary

Drugs to treat fever are widely used in children with fever. But there is a controversy about the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria. The effect of ibuprofen on fever compared to only mechanical measures is investigated in children with malaria.

Detailed description

Fever is the most apparent clinical manifestation of Plasmodium falciparum infection during the acute phase. The role of fever in defence against malaria or in other infectious diseases remains unclear. However, it has been shown that febrile temperatures inhibit the growth of P. falciparum in vitro. Antipyretic drugs are commonly and widely used to treat malarial fever in endemic areas. There is however a controversy about the benefit of reducing fever in children with malaria. Data from Gabon have revealed that neither paracetamol, nor naproxen or metamizol - antipyretics often used in this area - had an effect on fever clearance time. Worryingly, paracetamol increased parasite-clearance times (i.e. inhibited clearance of parasites) and decreased significantly the production of oxygen radicals and tumour necrosis factor (TNF), mechanisms of the innate immune response, pivotal to combat infections. Another antipyretic drug often used to treat malarial fever in endemic areas is ibuprofen. However, the rationale of its use and its capacity of reducing fever due to P. falciparum infections has never been proven in this area. Comparison: The effect of ibuprofen plus mechanical fever "treatment" (continuous fanning, tepid sponging, and cooling blankets) is compared to mechanical treatment alone to treat fever in children with malaria.

Conditions

Interventions

TypeNameDescription
DRUGIbuprofen

Timeline

Start date
2003-04-01
Completion
2004-01-01
First posted
2005-09-14
Last updated
2005-09-21

Locations

1 site across 1 country: Gabon

Source: ClinicalTrials.gov record NCT00167713. Inclusion in this directory is not an endorsement.