Surveillance for Nosocomial Infections in Pediatric Cancer Patients

Invasive Aspergillosis Clinical Trial

— Oncoped2006  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00843804
• Other study ID #: 03/07
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2009
• Last updated: June 25, 2010
• Start date: March 2007
• Est. completion date: June 2010

Study information

• Verified date: February 2009
• Source: University Hospital, Bonn
• Contact: Arne Simon, MD
• Phone: 004922828733254
• Email: asimon[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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)?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• pediatric cancer patients receiving inpatient treatment with chemotherapy, -

• radiotherapy or stem cell transplantation

Exclusion Criteria:

• no informed consent

• no inpatient treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspergillosis
• Bloodstream Infection
• Communicable Diseases
• Cross Infection
• Infection
• Invasive Aspergillosis
• Nosocomial Infections

Locations

Country	Name	City	State
Switzerland	Children's Hospital, Pediatric Oncology UNit	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Simon A, Besuden M, Vezmar S, Hasan C, Lampe D, Kreutzberg S, Glasmacher A, Bode U, Fleischhack G. Itraconazole prophylaxis in pediatric cancer patients receiving conventional chemotherapy or autologous stem cell transplants. Support Care Cancer. 2007 Feb;15(2):213-20. Epub 2006 Aug 30. — View Citation

Simon A, Bode U, Fleischhack G, Kramer M. Surveillance of nosocomial infections in pediatric cancer patients. Am J Infect Control. 2005 Dec;33(10):611. — View Citation

Simon A, Fleischhack G, Hasan C, Bode U, Engelhart S, Kramer MH. Surveillance for nosocomial and central line-related infections among pediatric hematology-oncology patients. Infect Control Hosp Epidemiol. 2000 Sep;21(9):592-6. — View Citation

Simon A, Fleischhack G, Wiszniewsky G, Hasan C, Bode U, Kramer MH. Influence of prolonged use of intravenous administration sets in paediatric cancer patients on CVAD-related bloodstream infection rates and hospital resources. Infection. 2006 Oct;34(5):258-63. — View Citation

Simon A, Gröger N, Wilkesmann A, Hasan C, Wiszniewsky G, Engelhart S, Kramer MH, Bode U, Ammann RA, Fleischhack G. Restricted use of glycopeptides in paediatric cancer patients with fever and neutropenia. Int J Antimicrob Agents. 2006 Nov;28(5):417-22. Epub 2006 Oct 12. — View Citation

External Links

•   web site of the actual study