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The Effect of Paracetamol in the Treatment of Non-Severe Malaria in Children in Guinea-Bissau
This study is ongoing, but not recruiting participants.
Sponsored by: Bandim Health Project
Information provided by: Bandim Health Project
ClinicalTrials.gov Identifier: NCT00137566
  Purpose

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 Intervention Phase
Malaria
Falciparum
Drug: acetaminophen (paracetamol)
Other: Placebo
Phase IV

MedlinePlus related topics: Malaria
Drug Information available for: Acetaminophen Chloroquine Chloroquine diphosphate Chloroquine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: The Effect of Paracetamol in the Treatment of Non-Severe Malaria in Children in Guinea-Bissau

Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • parasite clearance time [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • recrudescence rate [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • well-being of the child [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Study Start Date: May 2004
Estimated Study Completion Date: November 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Paracetamol: Experimental
Paracetamol as per protocol
Drug: acetaminophen (paracetamol)
Paracetamol tablets, 50 mg/kg/day for 3 days.
2 Placebo: Placebo Comparator
Inactive placebo as per protocol.
Other: Placebo

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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137566

Locations
Guinea-Bissau, Bissau
Bandim Health Project
Apartado 861, Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Study Director: Peter Aaby, Professor Bandim Health Project
  More Information

Publications:
Responsible Party: Bandim Health Project ( Poul-Erik Kofoed )
Study ID Numbers: PSB-2004-paracetamol
Study First Received: August 28, 2005
Last Updated: April 7, 2008
ClinicalTrials.gov Identifier: NCT00137566  
Health Authority: Guinea-Bissau: Ministry of Health;   Denmark: Ethics Committee

Keywords provided by Bandim Health Project:
malaria
treatment
paracetamol
chloroquine
Guinea-Bissau
children
P.falciparum

Study placed in the following topic categories:
Protozoan Infections
Chloroquine diphosphate
Chloroquine
Parasitic Diseases
Malaria
Acetaminophen

Additional relevant MeSH terms:
Sensory System Agents
Analgesics, Non-Narcotic
Coccidiosis
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009