Condition category
Infections and Infestations
Date applied
06/07/2006
Date assigned
17/08/2006
Last edited
16/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.muucsf.org/

Contact information

Type

Scientific

Primary contact

Dr Grant Dorsey

ORCID ID

Contact details

University of California
San Francisco (UCSF)
Box 0811
San Francisco
CA 94143
United States of America
+1 415 206 8687
gdorsey@medsfgh.ucsf.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.1

Study information

Scientific title

Acronym

AL vs DP efficacy and safety trial

Study hypothesis

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

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).

Study design

Randomised, single-blinded trial of two leading new antimalarial regimens at three sites with varying transmission intensity.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Artemether-lumefantrine and dihydroartemisinin-piperaquine

Primary outcome measures

Risk of treatment failure unadjusted and adjusted by genotyping at day 42

Secondary outcome measures

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

Overall trial start date

20/03/2006

Overall trial end date

20/07/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

400

Participant 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

Recruitment start date

20/03/2006

Recruitment end date

20/07/2006

Locations

Countries of recruitment

Uganda

Trial participating centre

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

Sponsor information

Organisation

Uganda Malaria Surveillance Project (Uganda)

Sponsor details

Mulago Hospital Complex
P.O.Box 7475
Kampala
-
Uganda
+256 41 530 692
info@muucsf.org

Sponsor type

Government

Website

http://www.muucsf.org

Funders

Funder type

Government

Funder name

Centers for Disease Control and Prevention/Global Malaria Prevention and Control Cooperative agreement number U50/CCU925112-01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department for International Development (DFID) through Malaria Consortium (SUBK0001)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/17525792
2. http://www.ncbi.nlm.nih.gov/pubmed/18545692

Publication citations

  1. Kamya MR, Yeka A, Bukirwa H, Lugemwa M, Rwakimari JB, Staedke SG, Talisuna AO, Greenhouse B, Nosten F, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial., PLoS Clin Trials, 2007, 2, 5, e20, doi: 10.1371/journal.pctr.0020020.

  2. Yeka A, Dorsey G, Kamya MR, Talisuna A, Lugemwa M, Rwakimari JB, Staedke SG, Rosenthal PJ, Wabwire-Mangen F, Bukirwa H, Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treating uncomplicated malaria: a randomized trial to guide policy in Uganda., PLoS ONE, 2008, 3, 6, e2390, doi: 10.1371/journal.pone.0002390.

Additional files

Editorial Notes