Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

Malaria Clinical Trial

Official title:

Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697787
• Other study ID #: CM/CRUN0012
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2012
• Last updated: July 29, 2015
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: Centre Muraz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

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.
• 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.

Locations

Country	Name	City	State
Burkina Faso	Clinical Reaserch Unit	Nanoro	Boulkiemdé

Sponsors (2)

Lead Sponsor	Collaborator
Centre Muraz	Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fever clearance time (FCT) Fever Clearance Time	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	28 days	No
Other	Gametocytes carriage	Gametocytes carriage including the estimation of the prevalence and density	28 days	No
Primary	Rate of treatment failures	The rate of the two ACTs treatment failures at day 28: all treatment failures, both parasitological and clinical (positive blood slide at day 28)	28 days	Yes
Secondary	RDT performance Vs microscopy	The proportion of discrepancies between the RDT and the microscopy results	28 days	No