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ISRCTN
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ISRCTN67520427
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ClinicalTrials.gov identifier
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Public title
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Uganda Malaria Surveillance Project - Combination therapies for treatment of uncomplicated falciparum malaria in Uganda: evaluation of efficacy, safety, and tolerability
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Scientific title
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Acronym
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UMSP
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Serial number at source
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N/A
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Study hypothesis
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To assess the efficacy, safety and tolerability of alternative antimalarial therapies for treatment of uncomplicated falciparum malaria as they compare to Chloroquine/Sulfadoxine-Pyrimethamine (CQ/SP) treatment.
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Lay summary
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Ethics approval
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No ethics information provided at time of registration.
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Study design
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Single-blind, randomized clinical trial
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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
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Participants - inclusion criteria
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1. Aged over six months
2. Fever (more than 37.5 ºC axillary) or history of fever in the previous 24 hours
3. Absence of any history of serious side effects to study medications, including allergy to sulfa drugs
4. No evidence of severe malaria or danger signs
5. No evidence of a concomitant febrile illness
6. P. falciparum mono-infection
7. Parasite density more than 2000/ul and less than 200,000/ul
8. Agreement to return for all scheduled follow-up visits
9. Provision of informed consent
10. No history of anti-folate or amodiaquine use in past seven days
11. Absence of pregnancy
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/11/2002
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Anticipated end date
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31/05/2004
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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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2160
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Interventions
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Chloroquine + sulfadoxine-pyrimethamine versus amodiaquine + sulfadoxine-pyrimethamine versuss amodiaquine + artesunate
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Primary outcome measure(s)
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1. 28-day risks for any recurrent infection
2. Recrudescence
3. New infections.
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Secondary outcome measure(s)
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1. Risk of recurrent infection unadjusted by genotyping at day 14
2. Presence of fever on days one to three
3. Parasitemia on days two and three
4. Change in haemoglobin level between the day of enrolment and the last day of follow-up
5. Presence of gametocytes during any follow-up day
6. Incidence of adverse events
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Sources of funding
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Financial support was provided by the Centers for Disease Control/Association of Schools of Public Health cooperative agreement, Malaria Surveillance and Control in Uganda (SA3569 & S1932-21/21) and the Department for International Development (DFID)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/16033307
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Contact name
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Dr
Arthur
Reingold
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Address
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University of California
104 Haviland Hall
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City/town
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Berkeley
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Zip/Postcode
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94720-7360
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Country
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United States of America
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Sponsor
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Uganda Malaria Surveillance Project (Uganda)
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Address
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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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7475
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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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mkamya@infocom.co.ug
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Date applied
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26/04/2005
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Last edited
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22/04/2008
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Date ISRCTN assigned
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10/05/2005
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