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

This study has been completed.

Sponsor:

Collaborator:

Muhimbili University of Health and Allied Sciences

Information provided by:

Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT00336375

First received: June 12, 2006

Last updated: October 31, 2007

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

June 12, 2006

Last Updated Date

October 31, 2007

Start Date ^ICMJE

June 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00336375 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Malaria

Intervention ^ICMJE

Drug: artemether-lumefantrine

All treatment doses given either accompanied or not-accompanied with intake of fatty food.

Other Name: All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food

Study Arm (s)

Experimental: 1
All treatment doses accompanied with intake of fatty food

Intervention: Drug: artemether-lumefantrine
Active Comparator: 2
All treatment doses not-accompanied with intake of fatty food.

Intervention: Drug: artemether-lumefantrine

Publications *

Carlsson AM, Ngasala BE, Dahlström S, Membi C, Veiga IM, Rombo L, Abdulla S, Premji Z, Gil JP, Björkman A, Mårtensson A. Plasmodium falciparum population dynamics during the early phase of anti-malarial drug treatment in Tanzanian children with acute uncomplicated malaria. Malar J. 2011 Dec 20;10:380.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 10 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Tanzania

Administrative Information

NCT Number ^ICMJE

NCT00336375

Other Study ID Numbers ^ICMJE

04/04/2006

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Karolinska University Hospital

Collaborators ^ICMJE

Muhimbili University of Health and Allied Sciences

Investigators ^ICMJE

Study Director:

Anders Bjorkman, Professor

Karolinska University Hospital

Information Provided By

Karolinska University Hospital

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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