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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00843804
Acronym
Oncoped2006
Enrollment
50
Registered
2009-02-13
Start date
2007-03-31
Completion date
2010-06-30
Last updated
2010-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodstream Infection, Invasive Aspergillosis, Nosocomial Infections

Keywords

nosocomial infection, bloodstream infection, central venous catheter, invasive Aspergillosis, Clostridium difficile associated disease

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)?

Interventions

None listed

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* no informed consent * no inpatient treatment

Countries

Switzerland

Contacts

Primary ContactArne Simon, MD
asimon@ukb.uni-bonn.de004922828733254
Backup ContactUdo Bode, MD
udo.bode@ukb.uni-bonn.de004922828733310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026