NCT01998295

Brief Summary

Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is not known whether the problem exist in Tanzania. This study assessed parasite clearance time and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among children with uncomplicated malaria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

November 15, 2013

Last Update Submit

March 15, 2014

Conditions

Instantaneous Clearance

Keywords

Clearance timeRecurrence timeArtemether/lumefantrineP. falciparumUncomplicated malariaChildren

Outcome Measures

Primary Outcomes (1)

  • Time to parasite clearance

    Time to parasite clearance was assessed by taking blood samples and examining it by light microscopy prior (0 hour) and during treatment at 4, 8, 12 hours and then 6 hourly until two consecutive negative blood slides.

    72 hours

Secondary Outcomes (1)

  • Time to recurrent infection

    42 days

Other Outcomes (2)

  • Time to parasite clearance

    7 days

  • Time to alleles clearance

    168 hours

Study Arms (1)

Artemether/lumefantrine

ACTIVE COMPARATOR

Artemether/lumefantrine tablets, 6 doses, for 3 days Dosage: 1. tablet for body weight between 5-14.9 Kilograms. 2. tablets for body weight between 15-24.9 Kilograms. 3. tablets for body weight between 25-34.9 Kilograms.

Drug: Artemether/lumefantrine

Interventions

Artemether/lumefantrineDRUG

Medication was given at 0, 8, 24, 36, 48 and 60 hours. Food was given to all patients prior to medication to ensure proper absorption of the drug.

Also known as: Coartem
Artemether/lumefantrine

Eligibility Criteria

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

You may qualify if:

  • Age 6-120 months
  • Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
  • No general danger signs or severe malaria present
  • Hemoglobin ≥5 g/dL
  • History of fever within 24 hours or axillary temperature ≥ 37.5 degree Celsius
  • No other cause of fever is detectable
  • No severe malnutrition
  • Guardian/patient has consented

You may not qualify if:

  • general danger signs or signs of severe falciparum malaria
  • severe malnutrition
  • febrile condition due to diseases other than malaria
  • regular medication which might interfere with antimalarial pharmacokinetics
  • contraindications to any medicine being used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, 65001, Tanzania

Location

Related Publications (1)

  • 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

MeSH Terms

Interventions

Artemether, Lumefantrine Drug Combination

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
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 28, 2013

Study Start

May 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

TA(1)