NCT00426439

Brief Summary

This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau. The genetic basis of the parasites for developing resistance will be examined. Children coming to one of the Health Centres with symptoms of malaria and a positive malaria test will be included. The children will be followed weekly until day 70. In case of reappearance of parasites the child will be re-treated with the opposite study drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2006

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

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 4, 2011

Status Verified

January 1, 2011

Enrollment Period

1.9 years

First QC Date

January 23, 2007

Last Update Submit

January 2, 2011

Conditions

Malaria, Falciparum

Keywords

malariaPlasmodium falciparumchildrenGuinea-BissauartemetherlumefantrinechloroquineCoartem

Outcome Measures

Primary Outcomes (1)

  • Parasite reappearance rate,

    70 days

Secondary Outcomes (4)

  • genetic markers of resistance

    70 days

  • recrudescence and re-infection rates

    70 days

  • Hospitalisation during follow-up

    70 days

  • Haemoglobin changes

    70 days

Study Arms (2)

1 Coartem

EXPERIMENTAL

Treatment of documented malaria in children following the dosages recommended by the manufacturer.

Drug: ChloroquineDrug: Artemether-lumefantrine (Coartem)

2 Chloroquine

ACTIVE COMPARATOR

The antimalarial actually used in Guinea-Bissau is the dosage of 50 mg/kg given twice a day for 3 days.

Drug: ChloroquineDrug: Artemether-lumefantrine (Coartem)

Interventions

ChloroquineDRUG

Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.

1 Coartem2 Chloroquine
Artemether-lumefantrine (Coartem)DRUG

Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, \< 34 kg: 4 tablets.

Also known as: Brand name: Coartem.
1 Coartem2 Chloroquine

Eligibility Criteria

Age6 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children presenting at one of the health centres in the study area
  • Symptoms suggestive of malaria
  • At least 20 P.falciparum parasites per 200 leucocytes
  • Living in the study area (to enable follow-up)

You may not qualify if:

  • Danger signs
  • By the responsible doctor evaluated to need to be transferred to the national hospital as an in-patient
  • Previous idiosyncratic reactions to any of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Apartado 861, Bissau Region, Guinea-Bissau

Location

Related Publications (2)

  • Jovel IT, Kofoed PE, Rombo L, Rodrigues A, Ursing J. Temporal and seasonal changes of genetic polymorphisms associated with altered drug susceptibility to chloroquine, lumefantrine, and quinine in Guinea-Bissau between 2003 and 2012. Antimicrob Agents Chemother. 2015 Feb;59(2):872-9. doi: 10.1128/AAC.03554-14. Epub 2014 Nov 24.

    PMID: 25421474DERIVED

  • Ursing J, Kofoed PE, Rodrigues A, Blessborn D, Thoft-Nielsen R, Bjorkman A, Rombo L. Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. J Infect Dis. 2011 Jan 1;203(1):109-16. doi: 10.1093/infdis/jiq001.

    PMID: 21148503DERIVED

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Interventions

ChloroquineArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Peter Aaby

    Bandim Health Project

    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

January 23, 2007

First Posted

January 24, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 4, 2011

Record last verified: 2011-01

Locations

GU(1)