The National Malaria Programme in Guinea-Bissau recommends paracetamol for all children treated for malaria. We want to evaluate, if this treatment has any effect on a) the well-being of the child, b) the parasite clearance time, and c) the rate of 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 the first 4 days and the once a week until day 35.

Condition	Intervention	Phase
Malaria, Falciparum	Drug: acetaminophen (paracetamol)	Phase IV

Further Study Details: 

Primary Outcomes: parasite clearence time; recrudescence rate
Secondary Outcomes: well-being of the child

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 1) the well-being of the child, b) the parasite clearance time, and c) 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 analyses will be performed. If 50% or more of the children in any of the study arms has 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.

Ages Eligible for Study:  up to  15 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

< 15 years 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 consedered to need the services of a hospital by the doctor in charge previous idiosyncratic reactions to chloroquine or paracetamol

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Please refer to this study by ClinicalTrials.gov identifier  NCT00137566

Poul-Erik Kofoed, MD      +45 76 36 22 30    pekofoed@dadlnet.dk
Lars Rombo, MD      +46 16 10 35 51    Lars.Rombo@dll.se

Guinea-Bissau, Bissau
      Bandim Health Project, Apartado 861,  Bissau,  Guinea-Bissau; Recruiting

Study chairs or principal investigators

Peter Aaby, proofessor,  Study Director,  Bandim Health Project   

Study ID Numbers:  PSB-2004-paracetamol
Last Updated:  August 29, 2005
Record first received:  August 28, 2005
ClinicalTrials.gov Identifier:  NCT00137566
Health Authority: Guinea-Bissau: Ministry of Health
ClinicalTrials.gov processed this record on 2005-08-30