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

Malaria Clinical Trial

Official title:

Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336375
• Other study ID #: 04/04/2006
• Status: Completed
• Phase: Phase 4
• First received: June 12, 2006
• Last updated: October 31, 2007
• Start date: June 2006
• Est. completion date: July 2006

Study information

• Verified date: October 2007
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

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

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:
• artemether-lumefantrine
All treatment doses given either accompanied or not-accompanied with intake of fatty food.

Locations

Country	Name	City	State
Tanzania	Fukayosi Primary Health Care Center	Fukayosi	Bagamoyo District

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples		72 hours
Secondary	Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading		72 hours