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Completed

NCT Number: NCT00336375

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

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fukayosi Primary Health Care Center

Fukayosi, Bagamoyo District, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemether-lumefantrine

Drug

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

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

Primary outcomes

  1. Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples

    Time frame: 72 hours

Secondary outcomes

  1. Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
Jun 13, 2006
Registry last updated
Nov 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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