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Sponsors and Collaborators: |
Albert Schweitzer Hospital, Netherlands Medical Research Unit, Lambaréné |
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Information provided by: | Albert Schweitzer Hospital, Netherlands |
ClinicalTrials.gov Identifier: | NCT00167713 |
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.
Condition | Intervention | Phase |
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Fever |
Drug: Ibuprofen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomised, Double-Blind, Placebo Controlled Study of the Antipyretic Effect of Ibuprofen in Children With Uncomplicated Malaria |
Estimated Enrollment: | 50 |
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.
Ages Eligible for Study: | 2 Years to 7 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Gabon, Moyen Ogooué | |
Medical research Unit, Lambaréné | |
Lambaréné, Moyen Ogooué, Gabon, B.P. 118 |
Principal Investigator: | Michel A. Missinou, PhD | Medical Research Unit, Lambaréné |
Study ID Numbers: | 04/2003/IBU |
Study First Received: | September 11, 2005 |
Last Updated: | September 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00167713 |
Health Authority: | Gabon: Ministry of Research |
Malaria Fever Ibuprofen Gabon |
Fever Protozoan Infections Signs and Symptoms |
Ibuprofen Parasitic Diseases Malaria |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Body Temperature Changes Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |