Status:
COMPLETED
Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for Treating Malaria
Lead Sponsor:
Bandim Health Project
Conditions:
Malaria
Effectiveness
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (\> 6 months) suffering from uncomplicated P. falciparum malaria....
Detailed Description
To objective of the study: 1. To measure the efficacy and safety of AL and DP in children for treating uncomplicated P. falciparum malaria. 2. To determine the capacity of each drug combination to pr...
Eligibility Criteria
Inclusion
- Mono-infection with P. falciparum detected by microscopy.
- Parasitemia of 1.000-200.000/µl asexual forms.
- Axillary temperature ≥37.5 ˚C or a history of fever within 24 hours.
- Ability to swallow oral medication.
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule.
- Informed consent
Exclusion
- Signs or symptoms of severe malaria
- Presence of general danger signs in children under 5
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to AL, DP or quinine.
- Domicile outside the study area.
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT04897919
Start Date
August 1 2015
End Date
December 1 2018
Last Update
April 12 2022
Active Locations (1)
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1
Bandim Health Centre
Bissau, Bissau Codex, Guinea-Bissau