NCT00167713

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 11, 2005

Last Update Submit

September 19, 2005

Conditions

Fever

Keywords

MalariaFeverIbuprofenGabon

Outcome Measures

Primary Outcomes (3)

  • Fever clearance time

  • Fever time

  • Area under the fever curve

Secondary Outcomes (2)

  • Parasite clearance time

  • Adverse event during the entire study period

Interventions

IbuprofenDRUG

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical research Unit, Lambaréné

Lambaréné, Moyen-Ogooué Province, B.P. 118, Gabon

Location

Related Publications (8)

  • 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.

    PMID: 2642531BACKGROUND

  • 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.

    PMID: 11484852BACKGROUND

  • Kluger MJ. Drugs for childhood fever. Lancet. 1992 Jan 4;339(8784):70. No abstract available.

    PMID: 1346006BACKGROUND

  • 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.

    PMID: 9291905BACKGROUND

  • 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.

    PMID: 11229858BACKGROUND

  • 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.

    PMID: 8560525BACKGROUND

  • 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.

    PMID: 10492798BACKGROUND

  • 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.

    PMID: 18503714DERIVED

Related Links

MeSH Terms

Conditions

FeverMalaria

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Michel A. Missinou, PhD

    Albert Schweitzer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

April 1, 2003

Study Completion

January 1, 2004

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations

GA(1)