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

Tracking Information

First Received Date ^ICMJE

October 4, 2007

Last Updated Date

October 4, 2007

Start Date ^ICMJE

September 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Uncomplicated Malaria

Intervention ^ICMJE

Drug: artemether-lumefantrine
Drug: Oral quinine

Study Arms / Comparison Groups

Experimental: Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days
Active Comparator: Tablets

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

302

Estimated Completion Date

April 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jane Achan, MMed	+256-772-410183	achanj@yahoo.co.uk
Contact: Daniel Kyabayinze, MSc	+256-772-744066	d.kyabayinze@malariaconsortium.org

Location Countries ^ICMJE

Uganda

Administrative Information

NCT ID ^ICMJE

NCT00540202

Responsible Party

Study ID Numbers ^ICMJE

QALE07

Study Sponsor ^ICMJE

Makerere University

Collaborators ^ICMJE

Ministry of Health, Uganda
Uganda Malaria Surveillence project

Investigators ^ICMJE

Principal Investigator:

Ambrose O Talisuna, PhD

Ministry of Health, Uganda

Information Provided By

Makerere University

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP