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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

Conditions
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Uncomplicated Malaria

Intervention / Treatment
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* Drug: artemether-lumefantrine
* Drug: Oral quinine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.Oral quinine<br>Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days | Drug: Oral quinine<br>* Quinine tablets given at 10mg/kg 8 hourly for 7 days<br>|
| Active Comparator: 2. Coartem<br>Tablets | Drug: artemether-lumefantrine<br>* Tablets taken twice daily for 3 days according to weight based guidelines.<br>* Other names: Coartem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Effectiveness, Oral quinine, Coartem, Uncomplicated malaria, Children