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ISRCTN
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ISRCTN75606663
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ClinicalTrials.gov identifier
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Public title
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Comparison of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability
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Scientific title
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Acronym
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AL vs DP efficacy and safety trial
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Serial number at source
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Version 1.1
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Study hypothesis
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To compare the efficacy, safety, and tolerability of Artemether-Lumefantrine (AL) and Dihydroartemisinin-Piperaquine (DP) for the treatment of uncomplicated falciparum malaria in Uganda.
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Ethics approval
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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).
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Study design
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Randomised, single-blinded trial of two leading new antimalarial regimens at three sites with varying transmission intensity.
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Countries of recruitment
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Uganda
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Disease/condition/study domain
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Malaria (P.falciparum)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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20/03/2006
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Anticipated end date
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20/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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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.
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Primary outcome measure(s)
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Risk of treatment failure unadjusted and adjusted by genotyping at day 42
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Centers for Disease Control and Prevention/Global Malaria Prevention and Control Cooperative agreement number U50/CCU925112-01
2. Department for International Development (DFID) through Malaria Consortium (SUBK0001)
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Trial website
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http://www.muucsf.org/
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Publications
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Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/17525792
2. http://www.ncbi.nlm.nih.gov/pubmed/18545692
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Contact name
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Dr
Grant
Dorsey
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Address
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University of California, San Francisco (UCSF)
Box 0811
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City/town
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San Francisco
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Zip/Postcode
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CA 94143
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Country
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United States of America
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Tel
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+1 415 206 8687
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Fax
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+1 415 648 8425
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Email
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gdorsey@medsfgh.ucsf.edu
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Sponsor
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Uganda Malaria Surveillance Project (Uganda)
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Address
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Mulago Hospital Complex
P.O.Box 7475
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City/town
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Kampala
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Zip/Postcode
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-
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Country
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Uganda
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Tel
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+256 41 530 692
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Fax
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+256 41 540 524
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Email
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info@muucsf.org
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Sponsor website:
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http://www.muucsf.org
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Date applied
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06/07/2006
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Last edited
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16/06/2008
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Date ISRCTN assigned
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17/08/2006
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