Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for Treating Malaria

NCT ID: NCT04897919

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2018-12-01

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.

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.

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 protect against re-infection.

3. To differentiate recrudescence from re-infections using PCR based methods

4. To determine haemoglobin values on days 0 and 42

5. To determine genetic polymorphisms in P. falciparum causing reparasitaemia. Study design This will be an open label, randomized, non inferiority trial conducted at the Bandim Health Centre, Guinea-Bissau. Patients with uncomplicated malaria who meet study inclusion criteria will be enrolled, randomised to treatment with either AL or DP. Medication will be provided and first dose given at the health centre.

Efficacy and safety evaluation Treatment outcomes will be early treatment failure, late clinical failure, late parasitological failure or adequate clinical and parasitological response as defined by the WHO. All will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow up visit. All adverse events will be recorded in the case record forms.

100µL of blood will be collected on Whatman 3MM filter-paper using a capillary tube on day 0, 7, 14, 28,and 42 and whenever re-parasitaemia is detected. Filter-papers will be dried and then placed inside separate sealed plastic bags.

In order to differentiate recrudescence from a re-infection genotyping using sequential analysis of pf-glurp, pfmsp1 and pfmsp2 will be done. Drug concentrations will be assessed on the week prior to re-parasitaemia. Haemoglobin concentration will be determined on day 0, 3 and 42 using a haemocueTM.

Conditions

Malaria; Effectiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dihydroartemisinin-piperaquine

First dose will be given supervised. The rest will be provided and the parents should take it at home.

Dihydroartemisinin-piperaquine dosing as recommended by manufacturer

Group Type: EXPERIMENTAL

Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet

Intervention Type: DRUG

Dihydroartemisinin-piperaquine is given as recommended by manufacturer and compared to the Artemether-lumefantrine group.

artemether-lumefantrine

First dose will be given supervised. The rest will be provided and the patients should take it at home.

Artemether-lumefantrine dosing as recommended by manufacturer

Group Type: ACTIVE_COMPARATOR

Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet

Intervention Type: DRUG

Artemether-Lumefantrine is given as recommended by manufacturer

Interventions

Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet

Dihydroartemisinin-piperaquine is given as recommended by manufacturer and compared to the Artemether-lumefantrine group.

Intervention Type: DRUG

Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet

Artemether-Lumefantrine is given as recommended by manufacturer

Intervention Type: DRUG

Other Intervention Names

Eurartesim; Coartem

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bandim Health Project

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bandim Health Centre

Bissau, Bissau Codex, Guinea-Bissau

Countries

Guinea-Bissau

Other Identifiers

Eurartesim2015

Identifier Type: -

Identifier Source: org_study_id