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
  Purpose

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


Condition
Nosocomial Infections
Bloodstream Infection
Invasive Aspergillosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Surveillance for Nosocomial Infections and Catheter-related Thrombotic Events in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Biospecimen Retention:   Samples With DNA

Blood culture isolates


Estimated Enrollment: 50
Study Start Date: March 2007
Estimated Study Completion Date: June 2010
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)?
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843804

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

Locations
Switzerland
Children's Hospital, Pediatric Oncology UNit Recruiting
Bern, Switzerland, CH 3010
Contact: Roland Ammann, MD    0041316329315    rolan.ammann@insel.ch   
Principal Investigator: Roland Ammann, MD         
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
  More Information

Additional Information:
Publications:
Responsible Party: Arne Simon (MD, PhD), Childrens Hospital medical Center, University of Bonn
ClinicalTrials.gov Identifier: NCT00843804     History of Changes
Other Study ID Numbers: 03/07
Study First Received: February 12, 2009
Last Updated: June 25, 2010
Health Authority: Germany: Ministry of Health

Keywords provided by University Hospital, Bonn:
nosocomial infection
bloodstream infection
central venous catheter
invasive Aspergillosis
Clostridium difficile associated disease

Additional relevant MeSH terms:
Aspergillosis
Communicable Diseases
Cross Infection
Infection
Dermatomycoses
Hyalohyphomycosis
Mycoses
Skin Diseases
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on October 23, 2014