Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

NCT ID: NCT01697787

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-09-30

Brief Summary

This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.

Detailed Description

Study background and purpose

• Resistance to usual drugs was widespread and has required a change of the malaria treatment by several countries
• Several countries have changed their first-line treatments to ACTs; mainly AL and ASAQ. & have adopted the use of RDTs prior to treatment
• Indeed, this contributes to decrease the number of unnecessary treatments and thus improve the management of malaria cases.
• In February 2005, Burkina Faso changed its national drug policy from Chloroquine to Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL)
• the country has also implemented the strategy of using the Rapid Diagnosis Tests (RDTs) for the diagnosis of malaria prior to treatment
• Though endemic countries are being encouraged to implement RDTs, choosing a particular RDT is not easy as several brands are available on the market.
• In addition, little information on the performance of RDTs in Africa is available and recently quality problems have been reported with some RDTs.
• In this context, it is important to locally assess the performance of RDTs compared with the microscopy, which is the gold standard for the malaria diagnosis and to assess the efficacy of the new drugs used for malaria treatment

This is a phase IV two-arm randomized open-label study aiming at recruiting 150 patients to assess the efficacy of ASAQ and AL in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the RDT compared to the microscopy

Conditions

Malaria

Study Design

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

Study Groups

Amodiaquine-Artesunate

ASAQ is produced by Sanofi-Aventis as CoarsucamTM and as artesunate-amodiaquine Winthrop®

Group Type: OTHER

Amodiaquine-Artesunate

Intervention Type: DRUG

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

Artemether-Lumefantrine

AL (tablets containing 20 mg of artemether and 120 mg of lumefantrine) is produced by Novartis

Group Type: OTHER

Artemether-lumefantrine

Intervention Type: DRUG

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

Interventions

Amodiaquine-Artesunate

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

Intervention Type: DRUG

Artemether-lumefantrine

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

Intervention Type: DRUG

Other Intervention Names

ASAQ Winthrop, Coarsucam; Coartem, Riamet

Eligibility Criteria

Inclusion Criteria

• Age above 6 months,
• eight above 5 kg;
• Positive blood slide (parasitaemia ≥ 2,000/μL to 200,000/μL) with Plasmodium falciparum monospecific infection ;
• Fever (axillary temperature above 37.5 °C) or history of fever in the preceding 24 hours;
• Haemoglobin value above or equal 5.0 g/dL
• Signed informed consent;
• Willingness and ability to comply with the study protocol for the duration of the trial.

Exclusion Criteria

• 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 (more than 1 in 24h), unconscious state, unable to sit or stand;
• Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study.
• Severe malnutrition (defined as weight for height less than 70% of the median NCHS/WHO reference)
• Known pregnancy

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

Centre Muraz

OTHER

Sponsor Role: lead

Responsible Party

Tinto Halidou

PharmD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Halidou Tinto, PharmD, PhD

Role: STUDY_DIRECTOR

IRSS/Centre Muraz

Locations

Clinical Reaserch Unit

Nanoro, Boulkiemdé, Burkina Faso

Countries

Burkina Faso

Other Identifiers

CM/CRUN0012

Identifier Type: -

Identifier Source: org_study_id