Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Information source: Makerere University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uncomplicated Malaria
Intervention: artemether-lumefantrine (Drug); Oral quinine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Makerere University Official(s) and/or principal investigator(s):
Ambrose O Talisuna, PhD, Principal Investigator, Affiliation: Ministry of Health, Uganda
Overall contact:
Jane Achan, MMed, Phone: +256-772-410183, Email: achanj@yahoo.co.uk
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.
Clinical Details
Official title: Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.
Secondary outcome: 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.
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
Minimum age: 6 Months.
Maximum age: 5 Years.
Gender(s): Both.
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
Locations and Contacts
Jane Achan, MMed, Phone: +256-772-410183, Email: achanj@yahoo.co.uk
Mulago National Referral Hospital, Kampala, Central 256, Uganda; Recruiting
Jane Achan, MMed, Phone: +256-772-410183, Email: achanj@yahoo.co.uk
Catherine Maiteki, MD, Phone: +256-712-840449, Email: cmaiteki@yahoo.com
Moses Kamya, MMed, Sub-Investigator
Additional Information
Related 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.
Starting date: September 2007
Last updated: October 4, 2007
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