Condition category
Infections and Infestations
Date applied
26/04/2005
Date assigned
10/05/2005
Last edited
22/04/2008
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

Dr Arthur Reingold

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

UMSP

Study hypothesis

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

No ethics information provided at time of registration.

Study design

Single-blind, randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Malaria

Intervention

Chloroquine + sulfadoxine-pyrimethamine versus amodiaquine + sulfadoxine-pyrimethamine versuss amodiaquine + artesunate

Intervention type

Drug

Phase

Not Specified

Drug names

Alternative therapies to chloroquine/sulfadoxine-pyrimethamine (CQ/SP)

Primary outcome measures

1. 28-day risks for any recurrent infection
2. Recrudescence
3. New infections.

Secondary outcome measures

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

Overall trial start date

01/11/2002

Overall trial end date

31/05/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

2160

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2002

Recruitment end date

31/05/2004

Locations

Countries of recruitment

Uganda

Trial participating centre

University of California
Berkeley
94720-7360
United States of America

Sponsor information

Organisation

Uganda Malaria Surveillance Project (Uganda)

Sponsor details

P.O. Box 7475
Kampala
7475
Uganda
+256 41 530 692
mkamya@infocom.co.ug

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16033307

Publication citations

  1. Results

    Yeka A, Banek K, Bakyaita N, Staedke SG, Kamya MR, Talisuna A, Kironde F, Nsobya SL, Kilian A, Slater M, Reingold A, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, Artemisinin versus nonartemisinin combination therapy for uncomplicated malaria: randomized clinical trials from four sites in Uganda., PLoS Med., 2005, 2, 7, e190, doi: 10.1371/journal.pmed.0020190.

Additional files

Editorial Notes