Treatment of Fever Due to Malaria With Ibuprofen

This study has been completed.
Sponsor:
Information provided by:
Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT00167713
First received: September 11, 2005
Last updated: September 19, 2005
Last verified: September 2005
  Purpose

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
Fever
Drug: Ibuprofen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-Blind, Placebo Controlled Study of the Antipyretic Effect of Ibuprofen in Children With Uncomplicated Malaria

Resource links provided by NLM:


Further study details as provided by Albert Schweitzer Hospital:

Primary Outcome Measures:
  • Fever clearance time
  • Fever time
  • Area under the fever curve

Secondary Outcome Measures:
  • Parasite clearance time
  • Adverse event during the entire study period

Estimated Enrollment: 50
Study Start Date: April 2003
Estimated Study Completion Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   2 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncomplicated falciparum malaria
  • 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:

  • Effective anti-malarial treatment for the present attack
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167713

Locations
Gabon
Medical research Unit, Lambaréné
Lambaréné, Moyen Ogooué, Gabon, B.P. 118
Sponsors and Collaborators
Albert Schweitzer Hospital
Investigators
Principal Investigator: Michel A. Missinou, PhD Albert Schweitzer Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00167713     History of Changes
Other Study ID Numbers: 04/2003/IBU
Study First Received: September 11, 2005
Last Updated: September 19, 2005
Health Authority: Gabon: Ministry of Research

Keywords provided by Albert Schweitzer Hospital:
Malaria
Fever
Ibuprofen
Gabon

Additional relevant MeSH terms:
Fever
Malaria
Body Temperature Changes
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014