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Trial NCT00137566

Resource URI: http://static.linkedct.org/resource/trials/NCT00137566
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/12917>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/23565>
linkedct:brief_title The Effect of Paracetamol in the Treatment of Non-Severe Malaria in Children in Guinea-Bissau
linkedct:condition <http://static.linkedct.org/resource/condition/4756>
linkedct:condition <http://static.linkedct.org/resource/condition/7686>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 15 Years
linkedct:eligibility_minimum_age N/A
linkedct:end_date November 2008
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date August 28, 2005
linkedct:id NCT00137566
linkedct:intervention <http://static.linkedct.org/resource/intervention/45860>
rdfs:label Trial NCT00137566
linkedct:lastchanged_date April 7, 2008
linkedct:lead_sponsor_agency Bandim Health Project
linkedct:location <http://static.linkedct.org/resource/location/68640>
linkedct:nct_id NCT00137566
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title The Effect of Paracetamol in the Treatment of Non-Severe Malaria in Children in Guinea-Bissau
linkedct:org_study_id PSB-2004-paracetamol
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/46479>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1249>
linkedct:oversight <http://static.linkedct.org/resource/oversight/678>
foaf:page <http://clinicaltrials.gov/show/NCT00137566>
linkedct:phase Phase 4
linkedct:primary_completion_date November 2006
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/42647>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/42650>
linkedct:reference <http://static.linkedct.org/resource/reference/18038>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/132813>
linkedct:source Bandim Health Project
linkedct:start_date May 2004
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date April 2008