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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
History of Changes

November 27, 2010
July 25, 2012
February 2009
February 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01249976 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children
Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children

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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Catheter-related Bloodstream Infection
Other: blood culture
blood culture
Other Name: blood culture
Experimental: catheter-spearing diagnostic methods
experimental
Intervention: Other: blood culture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
February 2012
February 2012   (final data collection date for primary outcome measure)

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:
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01249976
K060210, N° ID RCB :2006-A000515-46
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Fabrice Lesage, Md Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP