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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

February 12, 2009
June 25, 2010
March 2007
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Complete list of historical versions of study NCT00843804 on ClinicalTrials.gov Archive Site
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Surveillance for Nosocomial Infections in Pediatric Cancer Patients
Prospective Surveillance for Nosocomial Infections and Catheter-related Thrombotic Events in Pediatric Patients

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

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)?
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood culture isolates

Non-Probability Sample

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

  • Nosocomial Infections
  • Bloodstream Infection
  • Invasive Aspergillosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2010
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
  • no inpatient treatment
Both
up to 21 Years
No
Contact: Arne Simon, MD 004922828733254 asimon@ukb.uni-bonn.de
Contact: Udo Bode, MD 004922828733310 udo.bode@ukb.uni-bonn.de
Switzerland
 
NCT00843804
03/07
No
Arne Simon (MD, PhD), Childrens Hospital medical Center, University of Bonn
University Hospital, Bonn
Not Provided
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
University Hospital, Bonn
February 2009

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