Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso - Full Text View

Purpose

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.

Condition	Intervention	Phase
Malaria	Drug: Amodiaquine-Artesunate Drug: Artemether-lumefantrine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Artemether Lumefantrine

U.S. FDA Resources

Further study details as provided by Centre Muraz:

Primary Outcome Measures:

Rate of treatment failures [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
The rate of the two ACTs treatment failures at day 28: all treatment failures, both parasitological and clinical (positive blood slide at day 28)

Secondary Outcome Measures:

RDT performance Vs microscopy [ Time Frame: 28 days ] [ Designated as safety issue: No ]
The proportion of discrepancies between the RDT and the microscopy results

Other Outcome Measures:

Fever clearance time (FCT) Fever Clearance Time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Fever clearance time will be defined as the time (in days) from the time of the drug administration to the first two consecutive measurements on 2 different days of axillary temperature below 37.5°C
Gametocytes carriage [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Gametocytes carriage including the estimation of the prevalence and density

Estimated Enrollment:	150
Study Start Date:	October 2012
Estimated Study Completion Date:	June 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Amodiaquine-Artesunate ASAQ is produced by Sanofi-Aventis as CoarsucamTM and as artesunate-amodiaquine Winthrop®	Drug: 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. Other Name: ASAQ Winthrop, Coarsucam
Artemether-Lumefantrine AL (tablets containing 20 mg of artemether and 120 mg of lumefantrine) is produced by Novartis	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. Other Name: Coartem, Riamet

Arms

Assigned Interventions

Amodiaquine-Artesunate

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

Drug: 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.

Other Name: ASAQ Winthrop, Coarsucam

Artemether-Lumefantrine

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

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.

Other Name: Coartem, Riamet

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

Eligibility

Ages Eligible for Study:	6 Months to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697787

Locations

Burkina Faso
Clinical Reaserch Unit
Nanoro, Boulkiemdé, Burkina Faso, 218

Sponsors and Collaborators

Centre Muraz

Institute of Tropical Medicine, Belgium

Investigators

Study Director:

Halidou Tinto, PharmD, PhD

IRSS/Centre Muraz

More Information

No publications provided

Responsible Party:	Centre Muraz
ClinicalTrials.gov Identifier:	NCT01697787 History of Changes
Other Study ID Numbers:	CM/CRUN0012
Study First Received:	September 29, 2012
Last Updated:	April 19, 2013
Health Authority:	Burkina Faso: Ministry of Health

Keywords provided by Centre Muraz:

Treatment, diagnosis

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artemether
Artemisinins
Artesunate
Lumefantrine
Artemether-lumefantrine combination
Amodiaquine, artesunate drug combination
Antimalarials

Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Amebicides

ClinicalTrials.gov processed this record on May 23, 2013