Uganda Malaria Surveillance Project - Combination therapies for treatment of uncomplicated falciparum malaria in Uganda: evaluation of efficacy, safety, and tolerability

ISRCTN	ISRCTN67520427
DOI	https://doi.org/10.1186/ISRCTN67520427
Protocol serial number	N/A
Sponsor	Uganda Malaria Surveillance Project (Uganda)
Funder	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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Arthur Reingold
Scientific

University of California
104 Haviland Hall
Berkeley
94720-7360
United States of America

Primary study design	Interventional
Study design	Single-blind, randomized clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	UMSP
Study objectives	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(s)	No ethics information provided at time of registration.
Health condition(s) or problem(s) studied	Malaria
Intervention	Chloroquine + sulfadoxine-pyrimethamine versus amodiaquine + sulfadoxine-pyrimethamine versuss amodiaquine + artesunate
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Alternative therapies to chloroquine/sulfadoxine-pyrimethamine (CQ/SP)
Primary outcome measure(s)	1. 28-day risks for any recurrent infection 2. Recrudescence 3. New infections.
Key secondary outcome measure(s)	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
Completion date	31/05/2004

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Sex	Not Specified
Target sample size at registration	2160
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2002
Date of final enrolment	31/05/2004

University of California

Berkeley
94720-7360
United States of America

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/07/2005		Yes	No