Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children (Incat)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01249976
First received: November 27, 2010
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing diagnostic methods have been recently developed. The aim of the study is to evaluate three catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the differential time to positivity between a blood culture drawn from a peripherical vein and another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of the area around the insertion site of the CVC.


Condition Intervention
Catheter-related Bloodstream Infection
Other: blood culture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • the differential time to positivity [ Time Frame: maximum 24 hours ] [ Designated as safety issue: No ]
    To determine the sensibility, the specificity, the positive and negative predictible value of the measurement of the differential time to positivity between a blood culture drawn from a peripherical vein and another one drawn through the CVC, compared to the reference standard


Secondary Outcome Measures:
  • acridine orange leucocyte cytospin test. [ Time Frame: maximun 24 hours ] [ Designated as safety issue: No ]

    To determine the sensibility, the specificity, the positive and negative predictible value of two others catheter -spearing diagnostic methods, compared to the reference standard :

    - the exam of a blood sample drawn for the CVC and stained by acridine orange leucocyte cytospin test.


  • semi-quantitative skin culture [ Time Frame: maximum 24 hours ] [ Designated as safety issue: No ]

    To determine the sensibility, the specificity, the positive and negative predictible value of two others catheter -spearing diagnostic methods, compared to the reference standard :

    - the semi-quantitative skin culture of the area around the insertion site of the CVC.



Enrollment: 148
Study Start Date: February 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: catheter-spearing diagnostic methods
experimental
Other: blood culture
blood culture
Other Name: blood culture

Detailed Description:

Samples for the three techniques described above will be collected from the children admitted in Pediatric Intensive Care Unit with a CVC for more than 48 hours and with clinical or biological signs of systemic infection. Any investigation required to determine the origin of the infection will be performed, according to physician's judgement. If the CVC is removed or changed on a guide wire, a quantitative culture of the distal segment will be performed.

All the patients with a bloodstream infection and sampled according to the protocol will be included for statistical analysis. The physician and an independent medical expert will analyse if the bloodstream infection is CVC-related or not, according to the reference standard, by analysis of the clinical and bacteriological data, blinded towards the three studied techniques. The most optimal threshold will be determined and the sensibility, the specificity, the positive and negative predictable value of the three techniques will be calculated. Then sensibility of these three techniques will be compared.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 0 and 18 years.
  • Presence of a Central Venous Catheter for more than 48h (excepted umbilical catheter or peripherally inserted central catheters)
  • Presence of at least one clinical or biological sign of systemic infection
  • Parents are informed of the protocol and don't refuse the inclusion
  • Prior inclusion in this study for the same bloodstream infection

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249976

Locations
France
Hôpital Necker Enfants Malades
Paris, Ile de France, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Fabrice Lesage, Md Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01249976     History of Changes
Other Study ID Numbers: K060210, N° ID RCB :2006-A000515-46
Study First Received: November 27, 2010
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
blood culture
central venous catheter
acridine orange leucocyte cytospin test
semi-quantitative skin culture

ClinicalTrials.gov processed this record on July 23, 2014