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Completed

NCT Number: NCT01249976

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

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Key information

Conditions

Catheter-related Bloodstream Infection

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker Enfants Malades

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood culture

Other

blood culture

Primary outcomes

  1. the differential time to positivity

    Time frame: maximum 24 hours

    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 outcomes

  1. acridine orange leucocyte cytospin test.

    Time frame: maximun 24 hours

    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.

  2. semi-quantitative skin culture

    Time frame: maximum 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children

Acronym: Incat

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2010
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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