NCT00336375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

November 1, 2007

Status Verified

October 1, 2007

First QC Date

June 12, 2006

Last Update Submit

October 31, 2007

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

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

    72 hours

Secondary Outcomes (1)

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

    72 hours

Study Arms (2)

1

EXPERIMENTAL

All treatment doses accompanied with intake of fatty food

Drug: artemether-lumefantrine

2

ACTIVE COMPARATOR

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

Drug: artemether-lumefantrine

Interventions

artemether-lumefantrineDRUG

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

Also known as: All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food
12

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fukayosi Primary Health Care Center

Fukayosi, Bagamoyo District, Tanzania

Location

Related Publications (2)

  • Mwaiswelo R, Ngasala B, Jovel I, Xu W, Larsson E, Malmberg M, Gil JP, Premji Z, Mmbando BP, Martensson A. Prevalence of and Risk Factors Associated with Polymerase Chain Reaction-Determined Plasmodium falciparum Positivity on Day 3 after Initiation of Artemether-Lumefantrine Treatment for Uncomplicated Malaria in Bagamoyo District, Tanzania. Am J Trop Med Hyg. 2019 May;100(5):1179-1186. doi: 10.4269/ajtmh.18-0729.

    PMID: 30860013DERIVED

  • Carlsson AM, Ngasala BE, Dahlstrom S, Membi C, Veiga IM, Rombo L, Abdulla S, Premji Z, Gil JP, Bjorkman A, Martensson 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. doi: 10.1186/1475-2875-10-380.

    PMID: 22185672DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Anders Bjorkman, Professor

    Karolinska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 13, 2006

Study Start

June 1, 2006

Study Completion

July 1, 2006

Last Updated

November 1, 2007

Record last verified: 2007-10

Locations

TA(1)