NCT02089841

Brief Summary

Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

March 15, 2014

Last Update Submit

March 17, 2014

Conditions

Plasmodium Falciparum Malaria

Keywords

EfficacyArtemether/lumefantrineMalariaChildren

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients without parasitaemia on day 42.

    Proportion of patients without parasitaemia or with new infection as corrected by molecular genotyping on day 42 will be used to calculate the efficacy of the trial medicine.

    42 Days

Secondary Outcomes (1)

  • Plasma lumefantrine concentration

    7 days and 14 days

Other Outcomes (1)

  • Proportional of patients without parasitaemia on day 42

    42 days

Study Arms (1)

Artemether/lumefantrine

EXPERIMENTAL

In this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers. The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug.

Drug: Artemether-lumefantrine

Interventions

Artemether-lumefantrineDRUG

Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.

Also known as: Coartem
Artemether/lumefantrine

Eligibility Criteria

Age6 Months - 120 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Mono-infection with P. falciparum
  • Parasitaemia level of 2000 - 200,000/μL
  • Absence of danger signs or signs of severe malaria
  • Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility
  • Absence of other concomitant infections like pneumonia which can cause fever
  • No use of antimalarial drug two weeks prior to the study
  • Consent to comply to the protocol.

You may not qualify if:

  • Presence of general danger signs or signs of severe falciparum malaria
  • Severe malnutrition
  • Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases
  • Regular medication which might interfere with antimalarial pharmacokinetics
  • History of hypersensitivity reactions or contraindications to any medicine being used in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, P.O Box 65001, Tanzania

Location

MeSH Terms

Conditions

Malaria, FalciparumMalaria

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

  • Andreas Martensson, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 15, 2014

First Posted

March 18, 2014

Study Start

May 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

TA(1)