A phase III, randomised, double blind, multicentre study to evaluate the safety and efficacy of dalbavancin versus linezolid in the treatment of complicated skin and soft tissue infections with suspected gram-positive bacterial pathogens
| ISRCTN | ISRCTN63718248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63718248 |
| Secondary identifying numbers | N0123138529 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 30/08/2016
- 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 Martin Wiselka
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| martin.wiselka@uhl-tr.nhs.uk |
Study information
| Study design | Phase III randomised double blind multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A phase III, randomised, double blind, multicentre study to evaluate the safety and efficacy of dalbavancin versus linezolid in the treatment of complicated skin and soft tissue infections with suspected gram-positive bacterial pathogens |
| Study objectives | To compare how safe the trial medication dalbavancin is when compared to a standard of care treatment in patients suffering from complicated skin infections |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Infections and Infestations: Gram-positive bacterial pathogens |
| Intervention | Dalbavancin vs standard care |
| Intervention type | Other |
| Primary outcome measure | The clinical and microbiological responses to therapy. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/09/2003 |
| Completion date | 05/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Patients having infection consistent with complicated skin and soft tissue infection either involving deeper soft tissue or requiring significant surgical intervention 2. Patients to require 24hrs of parental therapy for suspected gram-positive complicated skin |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/09/2003 |
| Date of final enrolment | 05/08/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospitals of Leicester NHS Trust
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 |
Editorial Notes
30/08/2016: No publications found in PubMed, verifying study status with principal investigator.
