The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 28, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJuly 7, 2010
July 1, 2010
2.5 years
August 28, 2005
July 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
parasite clearance time
35 days
recrudescence rate
35 days
Secondary Outcomes (1)
well-being of the child
35 days
Study Arms (2)
1 Paracetamol
EXPERIMENTALParacetamol as per protocol
2 Placebo
PLACEBO COMPARATORInactive placebo as per protocol.
Interventions
Eligibility Criteria
You may qualify if:
- \< 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)
You may not qualify if:
- Severely ill children considered to need the services of a hospital by the doctor in charge
- Previous idiosyncratic reactions to chloroquine or paracetamol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bandim Health Project
Apartado 861, Bissau Region, Guinea-Bissau
Related Publications (3)
Russell FM, Shann F, Curtis N, Mulholland K. Evidence on the use of paracetamol in febrile children. Bull World Health Organ. 2003;81(5):367-72. Epub 2003 Jul 7.
PMID: 12856055BACKGROUNDJovel IT, Kofoed PE, Rombo L, Rodrigues A, Ursing J. Temporal and seasonal changes of genetic polymorphisms associated with altered drug susceptibility to chloroquine, lumefantrine, and quinine in Guinea-Bissau between 2003 and 2012. Antimicrob Agents Chemother. 2015 Feb;59(2):872-9. doi: 10.1128/AAC.03554-14. Epub 2014 Nov 24.
PMID: 25421474DERIVEDKofoed PE, Ursing J, Rodrigues A, Rombo L. Paracetamol versus placebo in treatment of non-severe malaria in children in Guinea-Bissau: a randomized controlled trial. Malar J. 2011 Jun 1;10:148. doi: 10.1186/1475-2875-10-148.
PMID: 21631932DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Aaby, Professor
Bandim Health Project
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 28, 2005
First Posted
August 30, 2005
Study Start
May 1, 2004
Primary Completion
November 1, 2006
Study Completion
January 1, 2010
Last Updated
July 7, 2010
Record last verified: 2010-07