Malaria Clinical Trial
Official title:
Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau
Verified date | April 2022 |
Source | Bandim Health Project |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 474 |
Est. completion date | December 1, 2018 |
Est. primary completion date | October 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Bandim Health Centre | Bissau | Bissau Codex |
Lead Sponsor | Collaborator |
---|---|
Bandim Health Project |
Guinea-Bissau,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequate clinical and parasitological response rate at day 42 | Cumulative percentages of children having successful treatment on day 42. | Day 42 | |
Secondary | re-infection vs recrudescence | Cumulative re-infection and recrudescence rates | Day 42 | |
Secondary | Haemoglobin level | Haemoglobin measured on day 42 | Day 42 |
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