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Sponsors and Collaborators: |
Makerere University Ministry of Health, Uganda Uganda Malaria Surveillence project |
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Information provided by: | Makerere University |
ClinicalTrials.gov Identifier: | NCT00540202 |
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 |
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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 |
Estimated Enrollment: | 302 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | April 2008 |
Arms | Assigned Interventions |
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1.Oral quinine: Experimental
Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days
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Drug: Oral quinine
Quinine tablets given at 10mg/kg 8 hourly for 7 days
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2. Coartem: Active Comparator
Tablets
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Drug: artemether-lumefantrine
Tablets taken twice daily for 3 days according to weight based guidelines.
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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
Ages Eligible for Study: | 6 Months to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jane Achan, MMed | +256-772-410183 | achanj@yahoo.co.uk |
Contact: Daniel Kyabayinze, MSc | +256-772-744066 | d.kyabayinze@malariaconsortium.org |
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 |
Principal Investigator: | Ambrose O Talisuna, PhD | Ministry of Health, Uganda |
Study ID Numbers: | QALE07 |
Study First Received: | October 4, 2007 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00540202 |
Health Authority: | Uganda: National Council for Science and Technology |
Effectiveness Oral quinine Coartem Uncomplicated malaria Children |
Benflumetol Artemether-lumefantrine combination Protozoan Infections Clotrimazole Quinine |
Miconazole Tioconazole Parasitic Diseases Malaria Artemether |
Anti-Infective Agents Antiprotozoal Agents Antiplatyhelmintic Agents Coccidiosis Physiological Effects of Drugs Anthelmintics Neuromuscular Agents Schistosomicides Pharmacologic Actions Antimalarials |
Antiparasitic Agents Sensory System Agents Analgesics, Non-Narcotic Antifungal Agents Therapeutic Uses Muscle Relaxants, Central Analgesics Peripheral Nervous System Agents Coccidiostats Central Nervous System Agents |