A randomised study of Agent A with Agent B against Agent C in the treatment of non-severe Plasmodium falciparum malaria

ISRCTN ISRCTN13706172
DOI https://doi.org/10.1186/ISRCTN13706172
Protocol serial number N0263115165
Sponsor Department of Health (UK)
Funder University College London Hospitals NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
25/04/2014
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

Dr C Whitty
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesIs Agent A better treatment than Agent B for patients with mild moderate falciparum malaria?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInfections and Infestations: Malaria
InterventionRandomised controlled trial:
A. Quinine and Fabsidar
B. Malarone
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Quinine, Fabsidar, Malarone
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration400
Key inclusion criteria400 Patients from Infectious/Tropical Diseases.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/07/2002
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Hospital for Tropical Diseases
London
WC1E 6JD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan