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 |
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Recruitment Status : Unknown
Verified October 2007 by Makerere University.
Recruitment status was: Recruiting
First Posted : October 5, 2007
Last Update Posted : October 5, 2007
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Sponsor:
Makerere University
Collaborators:
Ministry of Health, Uganda
Uganda Malaria Surveillance Project
Information provided by:
Makerere University
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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 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1.Oral quinine
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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Active Comparator: 2. Coartem
Tablets
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Drug: artemether-lumefantrine
Tablets taken twice daily for 3 days according to weight based guidelines.
Other Name: Coartem |
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 ]
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| Ages Eligible for Study: | 6 Months to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
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
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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00540202 |
| 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:
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Effectiveness Oral quinine Coartem Uncomplicated malaria Children |
Additional relevant MeSH terms:
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Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Lumefantrine Artemether Artemether, Lumefantrine Drug Combination Quinine Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Muscle Relaxants, Central Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents |