NCT00843804

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 28, 2010

Status Verified

February 1, 2009

First QC Date

February 12, 2009

Last Update Submit

June 25, 2010

Conditions

Keywords

nosocomial infectionbloodstream infectioncentral venous catheterinvasive AspergillosisClostridium difficile associated disease

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients with cancer during intensive induction / reinduction treatment (including conventional chemotherapy, radiotherapy and stem cell transplantation).

You may qualify if:

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

You may not qualify if:

  • no informed consent
  • no inpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital, Pediatric Oncology UNit

Bern, CH 3010, Switzerland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 11001263BACKGROUND
  • 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.

    PMID: 16330311BACKGROUND
  • 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.

    PMID: 17033749BACKGROUND
  • 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.

    PMID: 17046210BACKGROUND
  • 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.

    PMID: 16944217BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood culture isolates

MeSH Terms

Conditions

Cross InfectionSepsis

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeInflammation

Study Officials

  • Arne Simon, MD

    Children's Hospital Medical Center, University of Bonn, Germany

    PRINCIPAL INVESTIGATOR
  • Roland Ammann, MD

    Children's Hosptial, Bern, Switzerland

    STUDY DIRECTOR
  • Hans-Jürgen Lawas, MD

    Children's Hospital Medical Center, Düsseldorf, Germany

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

March 1, 2007

Study Completion

June 1, 2010

Last Updated

June 28, 2010

Record last verified: 2009-02

Locations