Condition category
Infections and Infestations
Date applied
04/11/2005
Date assigned
28/11/2005
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fred Wabwire-Mangen

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Uganda Malaria Surveillance Project

Sponsor details

P.O. Box 7475
Kampala
7475
Uganda

Sponsor type

Other

Website

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

Publication citations

Additional files

Editorial Notes