In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso - Full Text View

Sponsored by:	Centre Muraz
Information provided by:	Centre Muraz
ClinicalTrials.gov Identifier:	NCT00808951

Purpose

Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.

Condition	Intervention	Phase
Uncomplicated P. Falciparum Malaria in Children	Drug: Artesunate-amodiaquine Drug: Artemether-lumefantrine	Phase IV

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate Artemether Benflumetol Amodiaquine Amodiaquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	In Vivo and in Vitro Efficacy of the Recommended First Line Antimalarial Treatments (Artemether-Lumefantrine and Amodiaquine-Artesunate) in Children With Uncomplicated Malaria in Burkina Faso

Further study details as provided by Centre Muraz:

Primary Outcome Measures:

PCR unadjusted treatment failure (regardless of genotyping). [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PCR adjusted treatment failure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
PCR unadjusted treatment failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
PCR adjusted treatment failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Fever clearance time [ Time Frame: day 1, 2, 3 ] [ Designated as safety issue: No ]
Asexual parasite clearance time [ Time Frame: day 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
Gametocytaemia (prevalence and density) [ Time Frame: Day 7, 14, 21, 28, 35 and 42 ] [ Designated as safety issue: No ]
Safety profiles of the two treatments [ Time Frame: 42 days overall ] [ Designated as safety issue: Yes ]
Parasites in vitro sensitivity to the drugs tested and their relationship with the in vivo results [ Time Frame: before treatment and at the day of reccurrente parasitemia ] [ Designated as safety issue: No ]

Estimated Enrollment:	440
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Artemether -lumefantrine: Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso	Drug: Artemether-lumefantrine Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
Artesunate-amodiaquine: Experimental Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso	Drug: Artesunate-amodiaquine Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)

Detailed Description:

Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries have changed their antimalarial drug policy to Artemisinin Containing Therapies (ACT), which produce a rapid clinical and parasitological cure, reduce gametocyte carriage rate and are generally well tolerated. Burkina Faso has recently changed its policy for the treatment of uncomplicated malaria, from Chloroquine to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, there are still little available data on safety and efficacy of these treatments in Burkina Faso; a recent study carried out in Bobo Dioulasso showed that both treatments were extremely efficacious (adjusted treatment failure less than 5%) but with AL showing significantly high occurrence of recurrent infections during the 28-day follow up period. The higher risk for recurrent infections for AL was confirmed in a subsequent trial comparing AL with AQ-SP and dihydroartemisinin-piperaquine, but so far no direct comparison between AQ+AS and AL has been completed, though a study in Nanoro, near Ouagadougou, is ongoing. Thus, the present study aims at comparing the in vivo safety and efficacy of AL and AS-AQ (42-day follow-up),AND at comparing the in vitro sensitivity of the different ACT components, in patients with recurrent infection, with the results obtained in vivo.

Eligibility

Ages Eligible for Study:	6 Months to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 6 - 59 months
Weight > 5 kg
Mono-infection with P. falciparum
Parasitemia of 4,000-200,000 asexual parasites per µl
Fever: > 37.5 °C or history of fever in the preceding 24 hours
Haemoglobin > 5.0 g/dl
Signed informed consent by the parents or guardians
Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.

Exclusion Criteria:

Participation in any other clinical trial during the previous 30 days
Known hypersensitivity to the study drugs
Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)
Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
Known intercurrent illness or any condition which would place the subject at undue risk or interfere with the results of the study.
Severe malnutrition (weight for height <70% of the median NCHS/WHO reference)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808951

Contacts

Contact: Halidou Tinto, Pharm D., PhD

+226 ext 20984843

tintohalidou@yahoo.fr

Locations

Burkina Faso, Houet
Tinto Halidou
Bobo-Dioulasso, Houet, Burkina Faso, 01

Sponsors and Collaborators

Centre Muraz

More Information

webpage

This link exits the ClinicalTrials.gov site

Responsible Party:	IRSS/Centre Muraz ( Tinto Halidou )
Study ID Numbers:	Malactres-BF
Study First Received:	December 5, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808951
Health Authority:	Burkina Faso: Ministry of Health

Keywords provided by Centre Muraz:

Uncomplicated malaria
P falciparum
Children
National treatment protocol
Burkina Faso

Artemether-lumefantrine
Artesunate-amodiaquine
In vivo efficacy
In vitro efficacy

Study placed in the following topic categories:

Benflumetol
Artesunate
Artemether-lumefantrine combination
Protozoan Infections
Amodiaquine
Clotrimazole

Miconazole
Tioconazole
Parasitic Diseases
Malaria
Artemether
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Coccidiosis
Antiplatyhelmintic Agents
Anthelmintics
Schistosomicides
Pharmacologic Actions

Antimalarials
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Amebicides
Coccidiostats

ClinicalTrials.gov processed this record on January 16, 2009