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 |
| Secondary identifying numbers | N0263115165 |
- 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
Scientific
Hospital for Tropical Diseases
Mortimer Market
Capper Street
London
WC1E 6JD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is 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) studied | Infections and Infestations: Malaria |
| Intervention | Randomised controlled trial: A. Quinine and Fabsidar B. Malarone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Quinine, Fabsidar, Malarone |
| Primary outcome measure | 1. Time to full recovery 2. Side effects of treatment 3. Relapse of malaria. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2002 |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 400 |
| Key inclusion criteria | 400 Patients from Infectious/Tropical Diseases. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hospital for Tropical Diseases
London
WC1E 6JD
United Kingdom
WC1E 6JD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
