Fever Clinical Trial
Official title:
Randomised, Double-Blind, Placebo Controlled Study of the Antipyretic Effect of Ibuprofen in Children With Uncomplicated Malaria
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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