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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00540202
• Date of registration: 04/10/2007
• Prospective Registration: No
• Primary sponsor: Makerere University
• Public title: Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children QALE
• Scientific title: Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
• Date of first enrolment: September 2007
• Target sample size: 302
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00540202
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Uganda

Contacts

• Name: Jane Achan, MMed

• Name: Jane Achan, MMed

• Name: Ambrose O Talisuna, PhD
• Affiliation: Ministry of Health, Uganda

Key inclusion & exclusion criteria

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



Age minimum: 6 Months
Age maximum: 5 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Uncomplicated Malaria

Intervention(s)

Drug: Oral quinine

Drug: artemether-lumefantrine

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

QALE07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Uganda Malaria Surveillance Project

Ministry of Health, Uganda