Clincosm LogoSign in Get a demo

Epidemiology of Infections in Pediatric Cancer Patients

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00934115
Collaborator
(none)
200
Enrollment

Study Details

Study Description

Brief Summary

Infections are common causes of morbidity and mortality in pediatric cancer patients. Today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. Moreover, little data exist on the epidemiology of infections among pediatric patients with solid tumors.

The objectives of the present study are to define the incidence, categories of infections by organ systems, etiologic agents and risk factors for infections in different pediatric malignancies. The results of this study will help the investigators to better understand the epidemiology of infections in the different types of pediatric malignancies, enable the investigators to identify high risk patients, and design a better approach to empiric treatment of these patients.

A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center, Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly diagnosed with cancer and admitted to day care or inpatient departments with fever of >38.0 C will be included in the study. Demographic, clinical and microbiological figures will be collected in each center by a research assistant supervised by the infectious disease specialist. Data will be collected according to a pre-defined Patient Data Form and entered into an electronic data base that will be analyzed accordingly. In each event of febrile episode during chemotherapy, the following data will be collected by a research assistant using a patient data form and computerized software:

  • Demographic data: age, gender, ethnicity.

  • Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.

  • Imaging data

  • Microbiological data

  • Outcome

The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Official Title:
    Epidemiology of Infections in Pediatric Cancer Patients: A Prospective Multicenter Study in Israel
    Study Start Date :
    Jan 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 20 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Pediatric cancer patients admitted to hospital with fever

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Rabin Medical Center

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00934115
      Other Study ID Numbers:
      • 0061-07-RMC
      First Posted:
      Jul 8, 2009
      Last Update Posted:
      Jul 16, 2009
      Last Verified:
      Jul 1, 2009
      Keywords provided by , ,
      To define the incidence, categories of infections by organ systems, etiologic agents and risk
      Additional relevant MeSH terms:
      Infections
      Communicable Diseases

      Study Results

      No Results Posted as of Jul 16, 2009