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Surveillance for Nosocomial Infections in Pediatric Cancer Patients (Oncoped2006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843804
Recruitment Status : Unknown
Verified February 2009 by University Hospital, Bonn.
Recruitment status was:  Recruiting
First Posted : February 13, 2009
Last Update Posted : June 28, 2010
Information provided by:
University Hospital, Bonn

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

Condition or disease
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

  1. 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.
  2. 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.
  3. To promote patient's safety by means of quality assurance and a reduction of nosocomial infections.
  4. To describe objective outcome variables related to the documented NI events (mortality, duration of hospitalization, need for intensive care, need for surgical interventions)
  5. To intensify the practical collaboration of the health care team with infection control personnel and infectious disease specialists in this clinical context.
  6. 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).
  7. To detect bacterial isolates with emerging types of antimicrobial resistance.
  8. To describe the therapeutic use of antibacterial and antifungal agents in pediatric cancer patients related to nosocomial infections.
  9. To describe the incidence and incidence density of invasive Aspergillosis in pediatric cancer patients.
  10. 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).
  11. 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?
  12. How many of the children with an event do have congenital risk factors (thrombophilia)?
  13. What are the objective outcome parameters in this population considering antithrombotic treatment (at the discretion of the attending physicians)?

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Study Type : Observational
Estimated 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 : March 2007
Estimated Study Completion Date : June 2010

Biospecimen Retention:   Samples With DNA
Blood culture isolates

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with cancer during intensive induction / reinduction treatment (including conventional chemotherapy, radiotherapy and stem cell transplantation).

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
  • no inpatient treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843804

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Contact: Arne Simon, MD 004922828733254
Contact: Udo Bode, MD 004922828733310

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Children's Hospital, Pediatric Oncology UNit Recruiting
Bern, Switzerland, CH 3010
Contact: Roland Ammann, MD    0041316329315   
Principal Investigator: Roland Ammann, MD         
Sponsors and Collaborators
University Hospital, Bonn
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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
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Responsible Party: Arne Simon (MD, PhD), Childrens Hospital medical Center, University of Bonn Identifier: NCT00843804    
Other Study ID Numbers: 03/07
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: February 2009
Keywords provided by University Hospital, Bonn:
nosocomial infection
bloodstream infection
central venous catheter
invasive Aspergillosis
Clostridium difficile associated disease
Additional relevant MeSH terms:
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Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes