Uganda Malaria Surveillance Project - Comparison of amodiaquine plus artesunate and artemether-lumefantrine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability

ISRCTN	ISRCTN44534980
DOI	https://doi.org/10.1186/ISRCTN44534980
Protocol serial number	N/A
Sponsor	Uganda Malaria Surveillance Project
Funder	Centers for Disease Control and Prevention/Association of Schools of Public Health cooperative agreement, 'Malaria Surveillance and Control in Uganda' (SA3569 and S1932-21/21), and the Department for International Development (DFID)

Submission date: 04/11/2005
Registration date: 28/11/2005
Last edited: 14/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Fred Wabwire-Mangen
Scientific

Institute Of Public Health
Makerere University
P.O. Box 7072
Kampala
-
Uganda

Study information

Primary study design	Interventional
Study design	Randomised single-blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	UMSP
Study objectives	To compare the efficacy, safety, and tolerability of amodiaquine + artesunate and artemether + lumefantrine for the treatment of uncomplicated falciparum malaria in Uganda.
Ethics approval(s)	Ugandan National Council of Science and Technology, University of California San Francisco Committee for Human Research, University of California Berkeley IRB
Health condition(s) or problem(s) studied	Malaria
Intervention	Subjects will be randomized to treatment with amodiaquine + artesunate (AQ + AS) or artemether + lumefantrine (AL). Subjects in the AQ + AS arm will also receive placebo tablets to ensure that the number of doses received is identical in the two treatment groups. Subjects requiring repeat therapy (second-line therapy given for symptomatic malaria) will receive quinine.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amodiaquine + artesunate and artemether + lumefantrine
Primary outcome measure(s)	Primary outcome will be based on the risk of clinical rescue therapy. Pairwise comparisons between regimens will be made based on a per-protocol analysis.
Key secondary outcome measure(s)	1. Risk of clinical treatment failure 2. Risk of parasitological rescue therapy 3. Risk of parasitological treatment failure 4. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature >37.5 °C) or patient report of fever on days 1, 2, 3 5. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on day 2 and day 3 6. Change in mean haemoglobin from day 0 to 28 or day of repeat therapy 7. Proportion of subjects lacking gametocytes on day 0 with gametocytaemia on any follow-up day 8. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period, excluding treatment failures 9. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures
Completion date	14/07/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	10 Years
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. Age 1-10 years 2. Weight >10 kg 3. Fever (>37.5 °C axillary) or history of fever in the previous 24 hours 4. Provision of informed consent and agreement to follow-up for 28 days 5. P. falciparum mono-infection 6. Parasite density >2000/µl and <200,000/µl
Key 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 0
Date of first enrolment	14/12/2004
Date of final enrolment	14/07/2005

Locations

Countries of recruitment

Uganda

Study participating centre

Institute Of Public Health

Kampala
-
Uganda

Results and Publications

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