- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01249976
Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Children (Incat)
Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ile de France
-
Paris, Ile de France, France, 75015
- Hôpital Necker Enfants Malades
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: catheter-spearing diagnostic methods
experimental
|
blood culture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
maximum 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
maximun 24 hours
|
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. |
maximum 24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fabrice Lesage, Md, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K060210
- N° ID RCB :2006-A000515-46 (Other Identifier: AFSSAPS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Catheter-related Bloodstream Infection
-
University Hospital, AngersNot yet recruitingCatheter Infection | Catheter-Related Infections | Catheter Complications | Catheter Related Complication | Catheter-related Bloodstream Infection
-
Mayo ClinicTerminatedCatheter-related Bloodstream Infection (CRBSI) Nos | Bloodstream Infection Due to Central Venous Catheter | Bloodstream Infection Due to Hickman CatheterUnited States
-
Istanbul Medeniyet UniversityRecruitingCatheter-Related Infections | Central Venous Catheter Related Bloodstream Infection | Bloodstream Infection Due to Central Venous CatheterTurkey
-
Fudan UniversityShanghai Zhongshan Hospital; Huashan Hospital; Children's Hospital of Fudan University and other collaboratorsRecruitingQuality Improvement | Central Venous Catheter Associated Bloodstream Infection | CLABSI - Central Line Associated Bloodstream Infection | Central Venous Catheter Related Bloodstream Infection | Central Line Infection | CRBSI - Catheter Related Bloodstream Infection | Evidence-based Nursing PracticeChina
-
William Osler Health SystemAngiodynamics, Inc.CompletedCentral Venous Catheter | Catheter-Related Bloodstream Infection (CRBSI) NosCanada
-
NorthShore University HealthSystemUnknownCatheter-related Bloodstream Infection Due to Central Venous CatheterUnited States
-
Fraser HealthSterileCare Inc.; Center for Health Evaluation & Outcome ServicesRecruitingCentral Venous Catheter Thrombosis | Catheter Infection | Catheter Complications | Catheter | Catheter Blockage | Catheter Dysfunction | Central Line-associated Bloodstream Infection (CLABSI) | Central Venous Catheter Related Bloodstream InfectionCanada
-
Instituto Materno Infantil Prof. Fernando FigueiraBellisa Caldas Lopes; Thuanne Beatriz Silva Tenório; Rodrigo Melo Gallindo; Paulo... and other collaboratorsCompletedPediatric | Central Line-associated Bloodstream Infection (CLABSI) | Infection, Catheter-RelatedBrazil
-
Hospital Universitario GetafeUnknownComplication of Catheter | Catheter-related Bloodstream InfectionSpain
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingCatheter Infection | Catheter Complications | Preterm | Catheter-related Bloodstream InfectionItaly
Clinical Trials on blood culture
-
Central Hospital, Nancy, FranceCompletedBacteremia | Infective EndocarditisFrance
-
Assiut UniversityUnknownBlood Stream InfectionEgypt
-
Centre Hospitalier Universitaire de NiceCompletedBacteremia | Catheter-Related InfectionsFrance
-
Assiut UniversityUnknownNeonatal SepsisEgypt
-
Southeast University, ChinaThe First Affiliated Hospital with Nanjing Medical University; Northern Jiangsu...Recruiting
-
Assiut UniversityNot yet recruitingVAP - Ventilator Associated Pneumonia
-
Stanford UniversityBoston Scientific CorporationUnknownCholedocholithiasis | Bile Duct StrictureUnited States
-
Amsterdam UMC, location VUmcNot yet recruitingArtificial Intelligence | Machine Learning | Randomized Controlled Trial | Emergency Service, Hospital | Microbiology
-
Institute of Tropical Medicine, BelgiumUniversity Ghent; European and Developing Countries Clinical Trials Partnership... and other collaboratorsRecruitingBacterial InfectionsBenin
-
Assiut UniversityNot yet recruiting