NCT00540202

Brief Summary

We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
302

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 5, 2007

Status Verified

October 1, 2007

First QC Date

October 4, 2007

Last Update Submit

October 4, 2007

Conditions

Uncomplicated Malaria

Keywords

EffectivenessOral quinineCoartemUncomplicated malariaChildren

Outcome Measures

Primary Outcomes (1)

  • 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.

    28 days

Secondary Outcomes (1)

  • 1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group.

    28 days

Study Arms (2)

1.Oral quinine

EXPERIMENTAL

Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days

Drug: Oral quinine

2. Coartem

ACTIVE COMPARATOR

Tablets

Drug: artemether-lumefantrine

Interventions

artemether-lumefantrineDRUG

Tablets taken twice daily for 3 days according to weight based guidelines.

Also known as: Coartem
2. Coartem
Oral quinineDRUG

Quinine tablets given at 10mg/kg 8 hourly for 7 days

1.Oral quinine

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 6 and 59 months of age seen at the assessment centre during the study period
  • With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
  • With a microscopically confirmed monoinfection of Plasmodium falciparum
  • Able to tolerate oral therapy,
  • Whose parents/guardians have provided written informed consent.

You may not qualify if:

  • Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
  • Evidence of severe malaria.
  • Residence at more than 20km from the health clinic.
  • Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago National Referral Hospital

Kampala, Central Region, 256, Uganda

RECRUITING

Related Publications (3)

  • Fogg C, Bajunirwe F, Piola P, Biraro S, Checchi F, Kiguli J, Namiiro P, Musabe J, Kyomugisha A, Guthmann JP. Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda. Am J Trop Med Hyg. 2004 Nov;71(5):525-30.

    PMID: 15569777BACKGROUND

  • de Vries PJ, Bich NN, Van Thien H, Hung LN, Anh TK, Kager PA, Heisterkamp SH. Combinations of artemisinin and quinine for uncomplicated falciparum malaria: efficacy and pharmacodynamics. Antimicrob Agents Chemother. 2000 May;44(5):1302-8. doi: 10.1128/AAC.44.5.1302-1308.2000.

    PMID: 10770766BACKGROUND

  • Achan J, Tibenderana JK, Kyabayinze D, Wabwire Mangen F, Kamya MR, Dorsey G, D'Alessandro U, Rosenthal PJ, Talisuna AO. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial. BMJ. 2009 Jul 21;339:b2763. doi: 10.1136/bmj.b2763.

    PMID: 19622553DERIVED

MeSH Terms

Interventions

Artemether, Lumefantrine Drug CombinationQuinine

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsCinchona AlkaloidsAlkaloidsHeterocyclic CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ambrose O Talisuna, PhD

    Ministry of Health, Uganda

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Achan, MMed

CONTACT

+256-772-410183achanj@yahoo.co.uk

Daniel Kyabayinze, MSc

CONTACT

+256-772-744066d.kyabayinze@malariaconsortium.org

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

October 4, 2007

First Posted

October 5, 2007

Study Start

September 1, 2007

Study Completion

April 1, 2008

Last Updated

October 5, 2007

Record last verified: 2007-10

Locations

UG(1)