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

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ClinicalTrials.gov Identifier: NCT00540202
Recruitment Status : Unknown
Verified October 2007 by Makerere University.
Recruitment status was:  Recruiting
First Posted : October 5, 2007
Last Update Posted : October 5, 2007
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Uncomplicated Malaria Drug: artemether-lumefantrine Drug: Oral quinine Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Study Start Date : September 2007
Estimated Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1.Oral quinine
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
Active Comparator: 2. Coartem
Drug: artemether-lumefantrine
Tablets taken twice daily for 3 days according to weight based guidelines.
Other Name: Coartem

Outcome Measures

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

Secondary Outcome Measures :
  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. [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540202

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

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
Principal Investigator: Ambrose O Talisuna, PhD Ministry of Health, Uganda
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00540202     History of Changes
Other Study ID Numbers: QALE07
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: October 5, 2007
Last Verified: October 2007

Keywords provided by Makerere University:
Oral quinine
Uncomplicated malaria

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Sensory System Agents