Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed.

Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bandim Health Project
• Treatments: Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.