Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
UMSP
Study hypothesis
To compare the efficacy, safety, and tolerability of amodiaquine + artesunate and artemether + lumefantrine for the treatment of uncomplicated falciparum malaria in Uganda.
Ethics approval
Ugandan National Council of Science and Technology, University of California San Francisco Committee for Human Research, University of California Berkeley IRB
Study design
Randomised single-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Amodiaquine + artesunate and artemether + lumefantrine
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
14/12/2004
Overall trial end date
14/07/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
400
Participant 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
Recruitment start date
14/12/2004
Recruitment end date
14/07/2005
Locations
Countries of recruitment
Uganda
Trial participating centre
Institute Of Public Health
Kampala
-
Uganda
Funders
Funder type
Government
Funder name
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)
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