Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
UMSP
Study hypothesis
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.
Ethics approval
No ethics information provided at time of registration.
Study design
Single-blind, randomized clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Malaria
Intervention
Chloroquine + sulfadoxine-pyrimethamine versus amodiaquine + sulfadoxine-pyrimethamine versuss amodiaquine + artesunate
Intervention type
Drug
Phase
Not Specified
Drug names
Alternative therapies to chloroquine/sulfadoxine-pyrimethamine (CQ/SP)
Primary outcome measures
1. 28-day risks for any recurrent infection
2. Recrudescence
3. New infections.
Secondary outcome measures
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
Overall trial start date
01/11/2002
Overall trial end date
31/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
2160
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2002
Recruitment end date
31/05/2004
Locations
Countries of recruitment
Uganda
Trial participating centre
University of California
Berkeley
94720-7360
United States of America
Sponsor information
Organisation
Uganda Malaria Surveillance Project (Uganda)
Sponsor details
P.O. Box 7475
Kampala
7475
Uganda
+256 41 530 692
mkamya@infocom.co.ug
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
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)
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 in http://www.ncbi.nlm.nih.gov/pubmed/16033307
Publication citations
-
Results
Yeka A, Banek K, Bakyaita N, Staedke SG, Kamya MR, Talisuna A, Kironde F, Nsobya SL, Kilian A, Slater M, Reingold A, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, Artemisinin versus nonartemisinin combination therapy for uncomplicated malaria: randomized clinical trials from four sites in Uganda., PLoS Med., 2005, 2, 7, e190, doi: 10.1371/journal.pmed.0020190.