Status:
COMPLETED
Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Liverpool School of Tropical Medicine
East African Network for Monitoring Antimalarial Treatment
Conditions:
Fever
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE3
Brief Summary
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) \[amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL...
Eligibility Criteria
Inclusion
- Males and Females aged between 6 months and 59 months inclusive. In the sites where CDA is tested all recruited children will be aged between 12 months and 59 months inclusive (this arm was discontinued on 17th February 2008). This criterion applies only for the recruitment in the first follow up. For the second follow up, children having been included in the first follow up are eligible, regardless of their age.
- Body weight of 5 Kg and above.
- Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia ≥ 2,000/μL to 200,000/μL).
- Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
- Haemoglobin value ≥ 7.0 g/dl;
- Signed (or thumb-printed whenever parents/guardians are illiterate) informed consent by the parents or guardians. Note the informed consent will be asked only at recruitment and will cover the whole period of the study, including second active follow up and passive case detection.
- Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.
Exclusion
- Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
- Known hypersensitivity to the study drugs.
- Severe malaria.
- Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.
- Presence of intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency.
- Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
- Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carinii pneumonia in children born to HIV+ women.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
4112 Patients enrolled
Trial Details
Trial ID
NCT00393679
Start Date
July 1 2007
End Date
December 1 2009
Last Update
February 3 2014
Active Locations (8)
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1
Centre Muraz/IRSS
Bobo-Dioulasso, Burkina Faso
2
Albert Schweitzer Hospital
Lambaréné, Gabon
3
Manhiça Health Research Center
Manhiça, Mozambique
4
Hospital
Calabar, Nigeria