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
Secondary identifying numbers N/A
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

Study designRandomised single-blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymUMSP
Study objectivesTo 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) studiedMalaria
InterventionSubjects 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Amodiaquine + artesunate and artemether + lumefantrine
Primary outcome measurePrimary 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 measures1. 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 study start date14/12/2004
Completion date14/07/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit10 Years
SexBoth
Target number of participants400
Key inclusion criteria1. 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 criteria1. 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 enrolment14/12/2004
Date of final enrolment14/07/2005

Locations

Countries of recruitment

  • Uganda

Study participating centre

Institute Of Public Health
Kampala
-
Uganda

Sponsor information

Uganda Malaria Surveillance Project
Other

P.O. Box 7475
Kampala
7475
Uganda

Funders

Funder type

Government

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan