Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2003-04-30
2004-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ibuprofen
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Asexual parasitaemia between 20,000 and 200,000/µL
* Fever with temperature above 38 °C or history of fever during the preceding 24 hours
* Informed consent
Exclusion Criteria
* Antipyretic use within 6 hours of presentation
* Contraindications to the use of ibuprofen (history of asthma, dyspeptic symptoms, gastro-intestinal bleeding, or allergy to ibuprofen)
* Mixed plasmodial infection
* Haemoglobin \< 7 g/dL
* Packed-cell volume \< 20%
* White cell count \> 16,000/L
* Platelet count \< 40,000/µL
* Schizontaemia \> 50/µL
* Impaired consciousness
* Convulsions or history of convulsions
* Concomitant diseases masking assessment of response
2 Years
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Albert Schweitzer Hospital
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michel A. Missinou, PhD
Role: PRINCIPAL_INVESTIGATOR
Albert Schweitzer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical research Unit, Lambaréné
Lambaréné, Moyen-Ogooué Province, Gabon
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kwiatkowski D. Febrile temperatures can synchronize the growth of Plasmodium falciparum in vitro. J Exp Med. 1989 Jan 1;169(1):357-61. doi: 10.1084/jem.169.1.357.
Long HY, Lell B, Dietz K, Kremsner PG. Plasmodium falciparum: in vitro growth inhibition by febrile temperatures. Parasitol Res. 2001 Jul;87(7):553-5. doi: 10.1007/s004360100374.
Kluger MJ. Drugs for childhood fever. Lancet. 1992 Jan 4;339(8784):70. No abstract available.
Brandts CH, Ndjave M, Graninger W, Kremsner PG. Effect of paracetamol on parasite clearance time in Plasmodium falciparum malaria. Lancet. 1997 Sep 6;350(9079):704-9. doi: 10.1016/S0140-6736(97)02255-1.
Lell B, Sovric M, Schmid D, Luckner D, Herbich K, Long HY, Graninger W, Kremsner PG. Effect of antipyretic drugs in children with malaria. Clin Infect Dis. 2001 Mar 1;32(5):838-41. doi: 10.1086/319217. Epub 2001 Feb 23.
Krishna S, Pukrittayakamee S, Supanaranond W, ter Kuile F, Ruprah M, Sura T, White NJ. Fever in uncomplicated Plasmodium falciparum malaria: randomized double-'blind' comparison of ibuprofen and paracetamol treatment. Trans R Soc Trop Med Hyg. 1995 Sep-Oct;89(5):507-9. doi: 10.1016/0035-9203(95)90087-x.
Nwanyanwu OC, Ziba C, Kazembe PN. Paracetamol and ibuprofen for treatment of fever in Malawian children aged less than five years. Trans R Soc Trop Med Hyg. 1999 Jan-Feb;93(1):84. doi: 10.1016/s0035-9203(99)90191-8. No abstract available.
Matsiegui PB, Missinou MA, Necek M, Mavoungou E, Issifou S, Lell B, Kremsner PG. Antipyretic effect of ibuprofen in Gabonese children with uncomplicated falciparum malaria: a randomized, double-blind, placebo-controlled trial. Malar J. 2008 May 26;7:91. doi: 10.1186/1475-2875-7-91.
Related Links
Access external resources that provide additional context or updates about the study.
General information on malaria at the website of the Malaria Foundation International
Homepage of the Medical Research Unit, Lambaréné
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
04/2003/IBU
Identifier Type: -
Identifier Source: org_study_id