NCT00555282

Brief Summary

The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 5, 2010

Status Verified

February 1, 2010

Enrollment Period

3.7 years

First QC Date

November 7, 2007

Last Update Submit

February 4, 2010

Conditions

BacteriaemiaCatheter Related Bloodstream Infection

Keywords

central venous cathetercvccoated catheterbacteriaemiabloodstream infection

Outcome Measures

Primary Outcomes (2)

  • Incidence of catheter colonization

    after catheter removal

  • Incidence of bloodstream infection

    during treatment

Secondary Outcomes (2)

  • Safety of catheter: complications related to the catheter and adverse events in general, clinical therapy, TISS-Score, ICU stay, infection markers

    until discharge from ICU

  • Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization

    catheter removal

Study Arms (2)

1

EXPERIMENTAL

coated central venous catheter

Device: central venous catheter

2

ACTIVE COMPARATOR

standard central venous catheter

Device: central venous catheter

Interventions

central venous catheterDEVICE

coated central venous catheter

Also known as: Certofix Protect
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with probable ICU stay
  • Patient's first or second catheter placement during actual hospital stay
  • Anticipated indwelling central venous catheter period \>= 3 days (jugular vein, subclavian vein)
  • \>= 18 years of age
  • Written informed consent of patient or independent physician prior to the participation; in this case: written informed consent after recovery if possible

You may not qualify if:

  • The catheter will not be placed in the femoral vein
  • Inflammation of the skin at the site of puncture prior to puncture
  • Known hypersensitivity to any of the components (i.e. polyhexanide or related substances such as chlorhexidine)
  • Participation in another clinical trial
  • Emergency insertion of catheter in the field

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty Hospital Brno

Brno, 662 43, Czechia

Location

Faculty Hospital Charles University

Prague, 100 00, Czechia

Location

Related Publications (1)

  • Krikava I, Kolar M, Garajova B, Balik T, Sevcikova A, Roschke I, Sevcik P. The efficacy of a non-leaching antibacterial central venous catheter - a prospective, randomized, double-blind study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Jun;164(2):154-160. doi: 10.5507/bp.2019.022. Epub 2019 May 28.

    PMID: 31142873DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Central Venous Catheters

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vascular Access DevicesCathetersEquipment and Supplies

Study Officials

  • Jan Pachl, Prof. Dr.

    Faculty Hospital Charles University Prague

    PRINCIPAL INVESTIGATOR

  • Pavel Sevcik, Prof. Dr.

    Brno University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 8, 2007

Study Start

November 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 5, 2010

Record last verified: 2010-02

Locations

CZ(2)