Comparison of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability

ISRCTN	ISRCTN75606663
DOI	https://doi.org/10.1186/ISRCTN75606663
Protocol serial number	Version 1.1
Sponsor	Uganda Malaria Surveillance Project (Uganda)
Funders	Centers for Disease Control and Prevention/Global Malaria Prevention and Control Cooperative agreement number U50/CCU925112-01, Department for International Development (DFID) through Malaria Consortium (SUBK0001)

Submission date: 06/07/2006
Registration date: 17/08/2006
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Grant Dorsey
Scientific

University of California, San Francisco (UCSF)
Box 0811
San Francisco
CA 94143
United States of America

Phone	+1 415 206 8687
Email	gdorsey@medsfgh.ucsf.edu

Study information

Primary study design	Interventional
Study design	Randomised, single-blinded trial of two leading new antimalarial regimens at three sites with varying transmission intensity.
Secondary study design	Randomised controlled trial
Scientific title	Comparison of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability
Study acronym	AL vs DP efficacy and safety trial
Study objectives	To compare the efficacy, safety, and tolerability of Artemether-Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DP) for the treatment of uncomplicated falciparum malaria in Uganda.
Ethics approval(s)	1. Ugandan National Council of Science and Technology (HS 112; February 14 2006) 2. University of California San Francisco Committee for Human Research (H9926-28076-01; January 11 2006) 3. Makerere University Faculty of Medicine Research and Ethics Committee (January 31 2006).
Health condition(s) or problem(s) studied	Malaria (P.falciparum)
Intervention	Subjects will be randomised to treatment with AL or DP. Subjects in the DP arm will also receive placebo tablets to ensure that the number of doses received is identical in the two treatment groups. Subjects who fail initial therapy will receive quinine, the standard treatment for recurrent malaria in Uganda.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artemether-lumefantrine and dihydroartemisinin-piperaquine
Primary outcome measure(s)	Risk of treatment failure unadjusted and adjusted by genotyping at day 42
Key secondary outcome measure(s)	1. Prevalence of fever on days one to three 2. Prevalence of parasitemia on days two and three 3. Change in mean hemoglobin level between days zero and 42 (or day of treatment failure) 4. Prevalence of gametocytes during follow-up 5. Risk of serious adverse events during follow-up 6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding patients requiring quinine therapy 7. Selection of molecular markers associated with drug resistance
Completion date	20/07/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	10 Years
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. Aged six months to ten years 2. Weight more than 5 kg 3. Fever (more than 37.5°C axillary) or history of fever in the previous 24 hours 4. Provision of informed consent and agreement to follow-up for 42 days 5. Plasmodium falciparum mono-infection 6. Parasite density more than 2000/µl and less than 200,000/µl
Key exclusion criteria	1. Previously enrolled in this study 2. History of serious side effects to study medications 3. Evidence of a concomitant febrile illness 4. Evidence of severe malaria or danger signs 5. Repeated vomiting of study medications on day zero
Date of first enrolment	20/03/2006
Date of final enrolment	20/07/2006

Locations

Countries of recruitment

Uganda
United States of America

Study participating centre

University of California, San Francisco (UCSF)

San Francisco
CA 94143
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/06/2008		Yes	No
Other publications		18/05/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/10/2022: Internal review.