Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children (Incat)
Primary Purpose
Catheter-related Bloodstream Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood culture
Sponsored by
About this trial
This is an interventional diagnostic trial for Catheter-related Bloodstream Infection focused on measuring blood culture, central venous catheter, acridine orange leucocyte cytospin test, semi-quantitative skin culture
Eligibility 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:
Sites / Locations
- Hôpital Necker Enfants Malades
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
catheter-spearing diagnostic methods
Arm Description
experimental
Outcomes
Primary Outcome Measures
the differential time to positivity
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.
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
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.
Full Information
NCT ID
NCT01249976
First Posted
November 27, 2010
Last Updated
July 25, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01249976
Brief Title
Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children
Acronym
Incat
Official Title
Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-related Bloodstream Infection
Keywords
blood culture, central venous catheter, acridine orange leucocyte cytospin test, semi-quantitative skin culture
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
catheter-spearing diagnostic methods
Arm Type
Experimental
Arm Description
experimental
Intervention Type
Other
Intervention Name(s)
blood culture
Intervention Description
blood culture
Primary Outcome Measure Information:
Title
the differential time to positivity
Description
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
Time Frame
maximum 24 hours
Secondary Outcome Measure Information:
Title
acridine orange leucocyte cytospin test.
Description
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.
Time Frame
maximun 24 hours
Title
semi-quantitative skin culture
Description
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.
Time Frame
maximum 24 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Lesage, Md
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker Enfants Malades
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Learn more about this trial
Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children
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