Uncomplicated Malaria
Conditions
Keywords
Effectiveness, Oral quinine, Coartem, Uncomplicated malaria, Children
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.
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
Interventions
DRUGartemether-lumefantrine
Tablets taken twice daily for 3 days according to weight based guidelines.
DRUGOral quinine
Quinine tablets given at 10mg/kg 8 hourly for 7 days
Sponsors
Ministry of Health, Uganda
Uganda Malaria Surveillance Project
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. | 28 days |
Secondary
| Measure | 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 |
Countries
Uganda
Contacts
Primary ContactJane Achan, MMed
Backup ContactDaniel Kyabayinze, MSc
Outcome results
None listed