Condition category
Infections and Infestations
Date applied
07/12/2006
Date assigned
16/01/2007
Last edited
08/02/2011
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

Prof Uwe Querfeld

ORCID ID

Contact details

Department of Pediatric Nephrology
Charité Universitätsmedizin Berlin
Berlin
13353
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EA2/084/06

Study information

Scientific title

Acronym

Taurolock study

Study hypothesis

Use of taurolidine-citrate for catheter locking leads to a significant reduction of bacterial growth and catheter-related infections in paediatric patients with implanted central venous catheters

Ethics approval

Approval received by local ethics committee (Ethikkommission 2 am Campus Virchow Klinikum) on 29 September 2006 (ref: EA2/084/06).

Study design

Randomized prospective study in pediatric hospital with stratification for patients treated in renal/oncology/hematology departments

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Catheter-related infections

Intervention

Taurolidine-citrate vs heparin as catheter lock solutions

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Bacterial growth/biofilm formation in removed catheters

Secondary outcome measures

Catheter-related infections, catheter occlusions

Overall trial start date

01/01/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Paediatric patients with newly implanted central venous catheters

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Bacteremia/sepsis ongoing; allergy against heparin or taurolidine

Recruitment start date

01/01/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Pediatric Nephrology
Berlin
13353
Germany

Sponsor information

Organisation

Tauropharm (Germany)

Sponsor details

Jägerstraße 5a
97297
Waldbüttelbrunn
97297
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Tauropharm GmbH (Germany)

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