Oncoped2006: Surveillance for Nosocomial Infections in Pediatric Cancer Patients

Sponsor

University Hospital, Bonn (Other)

Overall Status

Unknown status

CT.gov ID

NCT00843804

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nosocomial Infections Bloodstream Infection Invasive Aspergillosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2007

Anticipated Study Completion Date :

Jun 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

no informed consent
no inpatient treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital, Pediatric Oncology UNit	Bern		Switzerland	CH 3010

Sponsors and Collaborators

University Hospital, Bonn

Investigators

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