Surveillance for Nosocomial Infections in Pediatric Cancer Patients
NCT ID: NCT00843804
Last Updated: 2010-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2007-03-31
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Compliance With AntibIotic TherapY Guidelines in French PICUs
NCT04642560
Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital
NCT02948335
Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit
NCT04039152
Surveillance Study of Bacterial Contamination of the Parent's Cell Phone in the NICU
NCT01560936
Health Care Associated Infection Surveillance in NICU
NCT03254316
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* radiotherapy or stem cell transplantation
Exclusion Criteria
* no inpatient treatment
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Bonn
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Childrens Hospital medical Center, University of Bonn
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arne Simon, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, University of Bonn, Germany
Roland Ammann, MD
Role: STUDY_DIRECTOR
Children's Hosptial, Bern, Switzerland
Hans-Jürgen Lawas, MD
Role: STUDY_CHAIR
Children's Hospital Medical Center, Düsseldorf, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital, Pediatric Oncology UNit
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
03/07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.