Condition category
Infections and Infestations
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
30/08/2016
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 Martin Wiselka

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109
martin.wiselka@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123138529

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Phase III randomised double blind multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infections and Infestations: Gram-positive bacterial pathogens

Intervention

Dalbavancin vs standard care

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

The clinical and microbiological responses to therapy.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/09/2003

Overall trial end date

05/08/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/09/2003

Recruitment end date

05/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals of Leicester NHS Trust

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

30/08/2016: No publications found in PubMed, verifying study status with principal investigator.