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The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137566
Recruitment Status : Unknown
Verified July 2010 by Bandim Health Project.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2005
Last Update Posted : July 7, 2010
Information provided by:
Bandim Health Project

Brief Summary:

The National Malaria Programme in Guinea-Bissau recommends paracetamol for all children treated for malaria. We, the investigators of the Bandim Health Project, want to evaluate whether this treatment has any effect on:

  • the well-being of the child;
  • the parasite clearance time; and
  • the rate of a re-appearance of parasites during 35 days of follow-up.

Children presenting at Bandim Health Centre with malaria will be treated with chloroquine plus paracetamol or chloroquine plus placebo. Blood samples will be obtained daily for the first 4 days and then once a week until day 35.

Condition or disease Intervention/treatment Phase
Malaria Falciparum Drug: acetaminophen (paracetamol) Other: Placebo Phase 4

Detailed Description:

A Cochrane Review was unable to show a superior antipyretic effect of paracetamol compared with placebo in febrile children. Recent research suggests that the time to parasite clearance in non-severe malaria is longer in children being given paracetamol. As the costs associated with the use of paracetamol is not trivial and the risk of adverse effects is not negligible, we want to evaluate the effects of paracetamol on:

  • the well-being of the child;
  • the parasite clearance time; and
  • the recrudescence rate.

Children presenting at Bandim Health Centre with symptoms of malaria and a malaria film showing mono-infection with P.falciparum will, following consent to participate, randomly be allocated to treatment with chloroquine and paracetamol or with chloroquine and placebo.

Blood samples will be obtained daily for the first 4 days. The children will be visited and a malaria film taken on day 7 and then weekly until day 35. On inclusion and whenever parasitaemia is detected a capillary blood sample will be taken for PCR analyses to be able to distinguish re-infection from recrudescence.

During follow-up children are recommended to present at the health centre in case of persistent fever or any other symptoms. Examination and treatment will be free of charge. Whenever a child has re-infection sulfadoxine/pyrimethamine will be used for re-treatment following the recommendation of the National malaria Programme.

After the inclusion of 80 children a preliminary analysis will be performed. If 50% or more of the children in any of the study arms have reappearing parasitaemia the study will be terminated.

If the parasite clearance time and especially the recrudescence rate is higher for children being given paracetamol the current recommendation from the National Malaria Programme should be reconsidered. If children treated with paracetamol feel better during the acute illness making it more likely for them to have en adequate intake of food and liquid this benefit should be considered in the evaluation of the current recommendations.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
Study Start Date : May 2004
Actual Primary Completion Date : November 2006
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 1 Paracetamol
Paracetamol as per protocol
Drug: acetaminophen (paracetamol)
Paracetamol tablets, 50 mg/kg/day for 3 days.

Placebo Comparator: 2 Placebo
Inactive placebo as per protocol.
Other: Placebo

Primary Outcome Measures :
  1. parasite clearance time [ Time Frame: 35 days ]
  2. recrudescence rate [ Time Frame: 35 days ]

Secondary Outcome Measures :
  1. well-being of the child [ Time Frame: 35 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • < 15 years of age
  • Presenting at Bandim Health Centre
  • Symptoms suggestive of malaria
  • At least 20 P. falciparum parasites per 200 leukocytes
  • Live in Bandim (to enable follow-up)

Exclusion Criteria:

  • Severely ill children considered to need the services of a hospital by the doctor in charge
  • Previous idiosyncratic reactions to chloroquine or paracetamol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137566

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Bandim Health Project
Apartado 861, Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
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Study Director: Peter Aaby, Professor Bandim Health Project
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Poul-Erik Kofoed, Bandim Health Project Identifier: NCT00137566    
Other Study ID Numbers: PSB-2004-paracetamol
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010
Keywords provided by Bandim Health Project:
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs