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

Makerere University

Status and phase: Unknown; Phase 4

Conditions: Uncomplicated Malaria

Treatments: Drug: artemether-lumefantrine; Drug: Oral quinine

Study type: Interventional

Funder types: Other

Identifiers

NCT00540202

QALE07

Details and patient eligibility

About

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.

Full 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

Enrollment: 302 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

1.Oral quinine

Experimental group

Description:

Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days

Treatment:

Drug: Oral quinine

2. Coartem

Active Comparator group

Description:

Tablets

Treatment:

Drug: artemether-lumefantrine