Surveillance for Nosocomial Infections in Pediatric Cancer Patients (Oncoped2006)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by University Hospital, Bonn.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University Hospital, Bonn

ClinicalTrials.gov Identifier:

NCT00843804

First received: February 12, 2009

Last updated: June 25, 2010

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 12, 2009

Last Updated Date

June 25, 2010

Start Date ^ICMJE

March 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00843804 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Surveillance for Nosocomial Infections in Pediatric Cancer Patients

Official Title ^ICMJE

Prospective Surveillance for Nosocomial Infections and Catheter-related Thrombotic Events in Pediatric Patients

Brief Summary

The Oncoped 2006 study implements a multicenter prospective surveillance module for nosocomial infections in pediatric cancer patients.

Detailed Description

Type of study:

Prospective multicenter surveillance study referring to file data collected routinely during the management of infectious and thrombotic complications in high risk pediatric cancer patients.

Primary aims of the Oncoped 2006 Study

To describe the epidemiology of selected nosocomial infections in pediatric cancer patients as well on the unit level as in a reference database of cumulative data from a prospective multicenter surveillance perspective.
To allow the participating institution
- to compare its own results with other centers and with the reference database (median and 75. percentile).
- to reduce the incidence density of nosocomial infections and the incidence rate of catheter-associated infections in pediatric cancer patients.
To promote patient's safety by means of quality assurance and a reduction of nosocomial infections.
To describe objective outcome variables related to the documented NI events (mortality, duration of hospitalization, need for intensive care, need for surgical interventions)
To intensify the practical collaboration of the health care team with infection control personnel and infectious disease specialists in this clinical context.
To describe the distribution of bacterial pathogens of blood stream infections and to determine the sensitivity (minimal inhibitory concentration) of bacterial pathogens detected in blood cultures to first and second line antimicrobial agents in this high risk population with a standardized method (central reference laboratory).
To detect bacterial isolates with emerging types of antimicrobial resistance.
To describe the therapeutic use of antibacterial and antifungal agents in pediatric cancer patients related to nosocomial infections.
To describe the incidence and incidence density of invasive Aspergillosis in pediatric cancer patients.
To describe the clinical impact of common and emerging viral respiratory pathogens (RSV, Influenza, hMPV, hCoV, hBoV) in pediatric cancer patients with nosocomial lower respiratory tract infection (central reference laboratory for emerging viral pathogens).
What is the incidence and incidence rate (per 1000 catheter utilization days) of thrombotic events in pediatric cancer patients and in patients with hemophilia, who have a CVAD in use?
How many of the children with an event do have congenital risk factors (thrombophilia)?
What are the objective outcome parameters in this population considering antithrombotic treatment (at the discretion of the attending physicians)?

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Blood culture isolates

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with cancer during intensive induction / reinduction treatment (including conventional chemotherapy, radiotherapy and stem cell transplantation).

Condition ^ICMJE

Nosocomial Infections
Bloodstream Infection
Invasive Aspergillosis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

pediatric cancer patients receiving inpatient treatment with chemotherapy, -
radiotherapy or stem cell transplantation

Exclusion Criteria:

no informed consent
no inpatient treatment

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Arne Simon, MD	004922828733254	asimon@ukb.uni-bonn.de
Contact: Udo Bode, MD	004922828733310	udo.bode@ukb.uni-bonn.de

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00843804

Other Study ID Numbers ^ICMJE

03/07

Has Data Monitoring Committee

Responsible Party

Arne Simon (MD, PhD), Childrens Hospital medical Center, University of Bonn

Study Sponsor ^ICMJE

University Hospital, Bonn

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Arne Simon, MD	Children's Hospital Medical Center, University of Bonn, Germany
Study Director:	Roland Ammann, MD	Children's Hosptial, Bern, Switzerland
Study Chair:	Hans-Jürgen Lawas, MD	Children's Hospital Medical Center, Düsseldorf, Germany

Information Provided By

University Hospital, Bonn

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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