Clinical trial NCT01697787: Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso
Official title: Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: Treatment, diagnosis
Lead sponsor: Centre Muraz
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2012-10-02
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Rate of treatment failures
timeFrame: 28 days
Secondary outcomes:
measure: RDT performance Vs microscopy
timeFrame: 28 days
Other outcomes:
measure: Fever clearance time (FCT) Fever Clearance Time
timeFrame: 28 days
measure: Gametocytes carriage
timeFrame: 28 days
Locations:
city: Nanoro
country: Burkina Faso
facility: Clinical Reaserch Unit
state: Boulkiemdé
Study officials:
affiliation: IRSS/Centre Muraz
name: Halidou Tinto, PharmD, PhD
role: STUDY_DIRECTOR
References: