Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

Muraz Center

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Drug: Amodiaquine-Artesunate

Drug: Artemether-lumefantrine

Study type

Interventional

Funder types

Other

Identifiers

NCT01697787

CM/CRUN0012

Details and patient eligibility

About

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.

Full 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

Enrollment

150 patients

Sex

All

Ages

6 months to 90 years old

Volunteers

No Healthy Volunteers

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