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

NCT01249976 | Completed

• 2 other identifiers: K060210N° ID RCB :2006-A000515-46
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-related Bloodstream Infection

Keywords

blood culture; central venous catheter; acridine orange leucocyte cytospin test; semi-quantitative skin culture

Outcome Measures

Primary Outcomes (1)

• 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

  maximum 24 hours

Secondary Outcomes (2)

• acridine orange leucocyte cytospin test.

  maximun 24 hours

• semi-quantitative skin culture

  maximum 24 hours

Study Arms (1)

catheter-spearing diagnostic methods

EXPERIMENTAL

experimental

Other: blood culture

Interventions

blood culture OTHER

blood culture

catheter-spearing diagnostic methods

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, Île-de-France Region, 75015, France

Location

MeSH Terms

Interventions

Blood Culture

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Fabrice Lesage, Md

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2010
• First Posted: November 30, 2010
• Study Start: February 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)