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

Uncomplicated Malaria Clinical Trial

— QALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00540202
• Other study ID #: QALE07
• Status: Recruiting
• Phase: Phase 4
• First received: October 4, 2007
• Last updated: October 4, 2007
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: October 2007
• Source: Makerere University
• Contact: Jane Achan, MMed
• Phone: +256-772-410183
• Email: achanj[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Uncomplicated Malaria

Intervention

Drug:
• artemether-lumefantrine
Tablets taken twice daily for 3 days according to weight based guidelines.
• Oral quinine
Quinine tablets given at 10mg/kg 8 hourly for 7 days

Locations

Country	Name	City	State
Uganda	Mulago National Referral Hospital	Kampala	Central

Sponsors (3)

Lead Sponsor	Collaborator
Makerere University	Ministry of Health, Uganda, Uganda Malaria Surveillance Project

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

de Vries PJ, Bich NN, Van Thien H, Hung LN, Anh TK, Kager PA, Heisterkamp SH. Combinations of artemisinin and quinine for uncomplicated falciparum malaria: efficacy and pharmacodynamics. Antimicrob Agents Chemother. 2000 May;44(5):1302-8. — View Citation

Fogg C, Bajunirwe F, Piola P, Biraro S, Checchi F, Kiguli J, Namiiro P, Musabe J, Kyomugisha A, Guthmann JP. Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda. Am J Trop Med Hyg. 2004 Nov;71(5):525-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.		28 days
Secondary	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