Condition category
Infections and Infestations
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
25/04/2014
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 C Whitty

ORCID ID

Contact details

Hospital for Tropical Diseases
Mortimer Market
Capper Street
London
WC1E 6JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263115165

Study information

Scientific title

Acronym

Study hypothesis

Is Agent A better treatment than Agent B for patients with mild moderate falciparum malaria?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Infections and Infestations: Malaria

Intervention

Randomised controlled trial:
A. Quinine and Fabsidar
B. Malarone

Intervention type

Drug

Phase

Not Specified

Drug names

Quinine, Fabsidar, Malarone

Primary outcome measures

1. Time to full recovery
2. Side effects of treatment
3. Relapse of malaria.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

01/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

400 Patients from Infectious/Tropical Diseases.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2002

Recruitment end date

01/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hospital for Tropical Diseases
London
WC1E 6JD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University College London Hospitals NHS Trust (UK)

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