Clinical trial NCT01249976: Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children
Official title: Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-related Bloodstream Infection
Keywords: blood culture
central venous catheter
acridine orange leucocyte cytospin test
semi-quantitative skin culture
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 148
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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:

Primary outcomes:
measure: the differential time to positivity
timeFrame: maximum 24 hours
Secondary outcomes:
measure: acridine orange leucocyte cytospin test.
timeFrame: maximun 24 hours
measure: semi-quantitative skin culture
timeFrame: maximum 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Fabrice Lesage, Md
role: PRINCIPAL_INVESTIGATOR
References: