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FeverPhase 4NCT00167713

Treatment of Fever Due to Malaria With Ibuprofen

A Phase 4 study testing Ibuprofen in people with Fever, run by Albert Schweitzer Hospital at 1 site in Gabon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 7 years
Conditions the study is for
Fever
What is being tested?
Ibuprofen
How many people
50 participants
Where
1 siteGabon
Study dates
Apr 2003to Jan 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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%
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Gabon1 site

  • Medical research Unit, Lambaréné

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

Other trials in Gabon

About this study

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.

Read the 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.

Conditions
Fever
Being tested
Ibuprofen
Keywords
Malaria, Fever, Ibuprofen, Gabon
Medical subject headings
Fever, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fever clearance time

  2. Fever time

  3. Area under the fever curve

Secondary outcomes (2)

  1. Parasite clearance time

  2. Adverse event during the entire study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startApr 2003
  3. Study completionJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00167713
Sponsor's protocol ID
04/2003/IBU
Status last verified
Sep 2005
First submitted
11 Sep 2005
Last updated
21 Sep 2005
Results posted
No

Publications

  • 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.

    PubMed 2642531

  • 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.

    PubMed 11484852

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

    PubMed 1346006

  • 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.

    PubMed 9291905

  • 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.

    PubMed 11229858

  • 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.

    PubMed 8560525

  • 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.

    PubMed 10492798

  • 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.

    PubMed 18503714

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibuprofen in people with Fever, run by Albert Schweitzer Hospital at 1 site in Gabon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fever clearance time. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00167713, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005.

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