Treatment of Fever Due to Malaria With Ibuprofen
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomised, Double-Blind, Placebo Controlled Study of the Antipyretic Effect of Ibuprofen in Children With Uncomplicated Malaria|
- Fever clearance time
- Fever time
- Area under the fever curve
- Parasite clearance time
- Adverse event during the entire study period
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||January 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167713
|Medical research Unit, Lambaréné|
|Lambaréné, Moyen Ogooué, Gabon, B.P. 118|
|Principal Investigator:||Michel A. Missinou, PhD||Albert Schweitzer Hospital|