Clinical trial NCT00843804: Surveillance for Nosocomial Infections in Pediatric Cancer Patients
Official title: Prospective Surveillance for Nosocomial Infections and Catheter-related Thrombotic Events in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nosocomial Infections
Bloodstream Infection
Invasive Aspergillosis
Keywords: nosocomial infection
bloodstream infection
central venous catheter
invasive Aspergillosis
Clostridium difficile associated disease
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 50
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with cancer during intensive induction / reinduction treatment (including conventional chemotherapy, radiotherapy and stem cell transplantation).

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)?

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* no informed consent
* no inpatient treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Children's Hospital, Pediatric Oncology UNit
Study officials:
affiliation: Children's Hospital Medical Center, University of Bonn, Germany
name: Arne Simon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hosptial, Bern, Switzerland
name: Roland Ammann, MD
role: STUDY_DIRECTOR
affiliation: Children's Hospital Medical Center, Düsseldorf, Germany
name: Hans-Jürgen Lawas, MD
role: STUDY_CHAIR
References:
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. doi: 10.1086/501809.
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. doi: 10.1016/j.ajic.2005.09.005. No abstract available.
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. doi: 10.1007/s15010-006-5646-y.
citation: Simon A, Groger 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. doi: 10.1016/j.ijantimicag.2006.08.007. Epub 2006 Oct 12.
citation: 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. doi: 10.1007/s00520-006-0125-7. Epub 2006 Aug 30.