Trial Information

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