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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping.

Resource links provided by NLM:


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
Experimental: 1
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.
Other Name: All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food
Active Comparator: 2
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.
Other Name: All drug doses of artemether-lumefantrine is given either accompanied with 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
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

No publications provided by Karolinska University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00336375     History of Changes
Other Study ID Numbers: 04/04/2006
Study First Received: June 12, 2006
Last Updated: October 31, 2007
Health Authority: Tanzania: Ministry of Health

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on April 17, 2014