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

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

This study is currently recruiting participants.

Verified by Makerere University, October 2007

First Received: October 4, 2007 No Changes Posted

Sponsor:	Makerere University
Collaborators:	Ministry of Health, Uganda Uganda Malaria Surveillance Project
Information provided by:	Makerere University
ClinicalTrials.gov Identifier:	NCT00540202

Purpose

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.

Condition	Intervention	Phase
Uncomplicated Malaria	Drug: artemether-lumefantrine Drug: Oral quinine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Artemether Benflumetol Co-artemether Quinine hydrochloride Quinine Quinine bisulfate Quinine Sulfate

U.S. FDA Resources

Further study details as provided by Makerere University:

Primary Outcome Measures:

1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. [ Time Frame: 28 days ]

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. [ Time Frame: 28 days ]

Estimated Enrollment:	302
Study Start Date:	September 2007
Estimated Study Completion Date:	April 2008

Arms	Assigned Interventions
1.Oral quinine: Experimental Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days	Drug: Oral quinine Quinine tablets given at 10mg/kg 8 hourly for 7 days
2. Coartem: Active Comparator Tablets	Drug: artemether-lumefantrine Tablets taken twice daily for 3 days according to weight based guidelines.

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

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540202

Contacts

Contact: Jane Achan, MMed	+256-772-410183	achanj@yahoo.co.uk
Contact: Daniel Kyabayinze, MSc	+256-772-744066	d.kyabayinze@malariaconsortium.org

Locations

Uganda, Central
Mulago National Referral Hospital	Recruiting
Kampala, Central, Uganda, 256
Contact: Jane Achan, MMed +256-772-410183 achanj@yahoo.co.uk
Contact: Catherine Maiteki, MD +256-712-840449 cmaiteki@yahoo.com
Sub-Investigator: Moses Kamya, MMed

Sponsors and Collaborators

Makerere University

Ministry of Health, Uganda

Uganda Malaria Surveillance Project

Investigators

Principal Investigator:

Ambrose O Talisuna, PhD

Ministry of Health, Uganda

More Information

Publications:

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.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	QALE07
Study First Received:	October 4, 2007
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00540202 History of Changes
Health Authority:	Uganda: National Council for Science and Technology

Keywords provided by Makerere University:

Effectiveness
Oral quinine
Coartem
Uncomplicated malaria
Children

Additional relevant MeSH terms:

Benflumetol
Anti-Infective Agents
Antiprotozoal Agents
Quinine
Physiological Effects of Drugs
Malaria
Neuromuscular Agents
Artemether
Antimalarials
Antiparasitic Agents
Sensory System Agents
Antifungal Agents
Therapeutic Uses

Muscle Relaxants, Central
Parasitic Diseases
Analgesics
Coccidiostats
Protozoan Infections
Coccidiosis
Antiplatyhelmintic Agents
Anthelmintics
Schistosomicides
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009