Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-27 @ 5:48 PM
Study NCT ID:
NCT00843804
Status:
UNKNOWN
Last Update Posted:
2010-06-28
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance for Nosocomial Infections in Pediatric Cancer Patients
Sponsor:
University Hospital, Bonn
Organization:
Study Overview
Official Title:
Prospective Surveillance for Nosocomial Infections and Catheter-related Thrombotic Events in Pediatric Patients
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Oncoped2006
Brief Summary:
The Oncoped 2006 study implements a multicenter prospective surveillance module for nosocomial infections in pediatric cancer patients.
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)?
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)?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: