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

Sponsor

Makerere University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00540202

Collaborator

Ministry of Health, Uganda (Other), Uganda Malaria Surveillance Project (Other)

302

Enrollment

Location

Arms

Duration (Months)

43.2

Patients Per Site Per Month

Study Details

Study Description

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

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2007

Anticipated Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Coartem

Arm

Intervention/Treatment

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 Names:

Coartem

Outcome Measures

Primary Outcome Measures

1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. [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. [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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