Chloroquine and Amodiaquine for Treatment of Malaria in Children
2 other identifiers
interventional
720
1 country
1
Brief Summary
This study will evaluate the efficacy of the treatment recommended by the National Malaria Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another anti-malarial drug, amodiaquine. The genetic basis of the parasites for developing resistance will be examined. Children coming to Bandim Health Centre with symptoms of malaria and a positive malaria test will be included. The children will be visited and malaria films will be obtained weekly until day 35. In case of a reappearance of parasites the children will be re-treated with sulfadoxine/pyrimethamine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2001
Typical duration 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
March 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 28, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedApril 8, 2008
April 1, 2008
3.2 years
August 28, 2005
April 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Parasite reappearance rate
hospitalization during follow-up
Secondary Outcomes (3)
Genetic markers in parasites
recrudescence rate
re-infection rate
Interventions
Eligibility Criteria
You may qualify if:
- Patients \< 15 years of age presenting at Bandim Health Centre
- Symptoms suggestive of malaria
- At least 20 P. falciparum parasites per 200 leukocytes in a thick film
- Live in Bandim (to enable follow-up)
You may not qualify if:
- Severely ill children considered needing the services of a hospital by the medical doctor in charge
- Stated medication with other antimalarials within one week prior to treatment
- Previous idiosyncratic reactions to any of the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bandim Health Project
Apartado 861, Bissau Region, Guinea-Bissau
Related Publications (1)
Jovel 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: 25421474DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Aaby
Bandim Health Project
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 28, 2005
First Posted
August 30, 2005
Study Start
March 1, 2001
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
April 8, 2008
Record last verified: 2008-04