Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping - Full Text View

Sponsors and Collaborators:	Karolinska University Hospital Muhimbili University of Health and Allied Sciences
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00336375

Purpose

The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. Study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.

Condition	Intervention	Phase
Malaria	Drug: artemether-lumefantrine	Phase IV

MedlinePlus related topics: Malaria

Drug Information available for: Artemisinin Artemether Benflumetol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping.

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:

Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples [ Time Frame: 72 hours ]

Secondary Outcome Measures:

Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading [ Time Frame: 72 hours ]

Enrollment:	50
Study Start Date:	June 2006
Study Completion Date:	July 2006

Arms	Assigned Interventions
1: Experimental All treatment doses accompanied with intake of fatty food	Drug: artemether-lumefantrine All treatment doses given either accompanied or not-accompanied with intake of fatty food.
2: Active Comparator All treatment doses not-accompanied with intake of fatty food.	Drug: artemether-lumefantrine All treatment doses given either accompanied or not-accompanied with intake of fatty food.

Eligibility

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 1-10 years
Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
No general danger signs or severe malaria present
Haemoglobin ≥70 g/L
History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
No other cause of fever is detectable
No severe malnutrition
Guardian/patient has understood the procedures of the study and willing to participate

Exclusion Criteria:

Not able to drink or breastfeed
Vomiting everything
Recent history of convulsions
Lethargic or unconscious
Unable to sit or stand (as appropriate for age)
History of allergy to test drugs
History of intake of any drugs other than paracetamol and aspirin within 3 days
Symptoms/signs of severe malaria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336375

Locations

Tanzania, Bagamoyo District
Fukayosi Primary Health Care Center
Fukayosi, Bagamoyo District, Tanzania

Sponsors and Collaborators

Karolinska University Hospital

Muhimbili University of Health and Allied Sciences

Investigators

Study Director:

Anders Bjorkman, Professor

Karolinska University Hospital

More Information

Study ID Numbers:	04/04/2006
Study First Received:	June 12, 2006
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00336375
Health Authority:	Tanzania: Ministry of Health

Study placed in the following topic categories:

Benflumetol
Protozoan Infections
Artemisinins
Clotrimazole
Miconazole

Artemisinine
Tioconazole
Parasitic Diseases
Malaria
Artemether

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antiplatyhelmintic Agents
Coccidiosis

Antifungal Agents
Therapeutic Uses
Anthelmintics
Coccidiostats
Schistosomicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009