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Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children (QALE)

Primary Purpose

Uncomplicated Malaria

Status

Unknown status

Phase

Phase 4

Locations

Uganda

Study Type

Interventional

Intervention

artemether-lumefantrine

Oral quinine

About this trial

This is an interventional treatment trial for Uncomplicated Malaria focused on measuring Effectiveness, Oral quinine, Coartem, Uncomplicated malaria, Children

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Mulago National Referral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1.Oral quinine

2. Coartem

Arm Description

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

Tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00540202

First Posted

October 4, 2007

Last Updated

October 4, 2007

Sponsor

Makerere University

Collaborators

Ministry of Health, Uganda, Uganda Malaria Surveillance Project

1. Study Identification

Unique Protocol Identification Number

NCT00540202

Brief Title

Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

Acronym

QALE

Official Title

Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Makerere University

Collaborators

Ministry of Health, Uganda, Uganda Malaria Surveillance Project

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uncomplicated Malaria

Keywords

Effectiveness, Oral quinine, Coartem, Uncomplicated malaria, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1.Oral quinine

Arm Type

Experimental

Arm Description

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

Arm Title

2. Coartem

Arm Type

Active Comparator

Arm Description

Tablets

Intervention Type

Drug

Intervention Name(s)

artemether-lumefantrine

Other Intervention Name(s)

Coartem

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oral quinine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jane Achan, MMed

Phone

+256-772-410183

achanj@yahoo.co.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Kyabayinze, MSc

Phone

+256-772-744066

d.kyabayinze@malariaconsortium.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ambrose O Talisuna, PhD

Organizational Affiliation

Ministry of Health, Uganda

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mulago National Referral Hospital

City

Kampala

State/Province

Central

ZIP/Postal Code

256

Country

Uganda

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jane Achan, MMed

Phone

+256-772-410183

achanj@yahoo.co.uk

First Name & Middle Initial & Last Name & Degree

Catherine Maiteki, MD

Phone

+256-712-840449

cmaiteki@yahoo.com

First Name & Middle Initial & Last Name & Degree

Moses Kamya, MMed

12. IPD Sharing Statement

Citations:

PubMed Identifier

15569777

Citation

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.

Results Reference

background

PubMed Identifier

10770766

Citation

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.

Results Reference

background

PubMed Identifier

19622553

Citation

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.

Results Reference

derived

Learn more about this trial

Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

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