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

June 12, 2006
October 31, 2007
June 2006
Not Provided
Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples [ Time Frame: 72 hours ]
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Complete list of historical versions of study NCT00336375 on ClinicalTrials.gov Archive Site
Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading [ Time Frame: 72 hours ]
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Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping
Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
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
  • 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
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.
 
Completed
50
July 2006
Not Provided

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
Both
1 Year to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00336375
04/04/2006
Not Provided
Not Provided
Karolinska University Hospital
Muhimbili University of Health and Allied Sciences
Study Director: Anders Bjorkman, Professor Karolinska University Hospital
Karolinska University Hospital
October 2007

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