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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Makerere University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ministry of Health, Uganda
Uganda Malaria Surveillance Project
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00540202
First received: October 4, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

Resource links provided by NLM:


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
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
Tablets
Drug: artemether-lumefantrine
Tablets taken twice daily for 3 days according to weight based guidelines.
Other Name: Coartem

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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00540202     History of Changes
Other Study ID Numbers: QALE07
Study First Received: October 4, 2007
Last Updated: October 4, 2007
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:
Protozoan Infections
Malaria
Parasitic Diseases
Artemether
Artemether-lumefantrine combination
Artemisinins
Lumefantrine
Quinine
Analgesics
Analgesics, Non-Narcotic
Anthelmintics
Anti-Infective Agents
Antifungal Agents
Antimalarials
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Central Nervous System Agents
Coccidiostats
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Schistosomicides
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014