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Ceftriaxone in Non-neutropenic Fever

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225718
First Posted: October 21, 2010
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adam Esbenshade, Vanderbilt University Medical Center
  Purpose

This is a retrospective chart review of all patients cared for at Monroe Carell Jr. Children's Hospital at Vanderbilt including the following:

  • patients between 2007-2009 with malignancy, Langerhans cell histiocytosis (LCH) or hemophagocytic lymphohistiocytosis (HLH) and a central venous catheter who were under 23 years of age at time of diagnosis in order to ascertain the associated symptoms, management and outcome of all episodes of non-neutropenic fever.
  • to identify a subset of low-risk patients that can be safely managed without use of empiric antibiotics.

Condition
Histiocytosis Pediatric Patients With Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Ceftriaxone in Non-neutropenic Fever

Resource links provided by NLM:


Further study details as provided by Adam Esbenshade, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Incidence of catheter-associated blood stream infections from all episodes of non-neutropenic fever in pediatric oncology, Langerhans cell histiocytosis or Hemophagocytic lymphohistiocytosis patients diagnosed and treated at Vanderbilt [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Identify risk factors associated with increased risk for catheter-associated blood stream infections in non-neutropenic pediatric oncology and histiocytosis patients with unexplained fever by collecting data for all eligible medical records. [ Time Frame: 12 months ]
    Medical records will be reviewed to identify age of patient at diagnosis and at time of non-neutropenic fever episodes,diagnosis, type of central venous line and number of days in place,all blood cultures obtained during treatment, and dates when last chemotherapy was given, presence of symptoms, lab parameters, presentation to clinic versus emergency room and presence of hemodynamic instability.

  • Effectiveness of administering empiric cefepime or ceftriaxone in a non-neutropenic oncology or histiocytic patient is estimated, using available microbiologic and antimicrobial susceptibility data from blood cultures [ Time Frame: 12 months ]
    Medical chart is reviewed to collect data if patient received ceftriaxone or other antibiotics, assessment of patient's clinical condition and status of central line, and outcome of blood cultures.


Enrollment: 463
Study Start Date: August 2010
Study Completion Date: June 25, 2016
Primary Completion Date: June 25, 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients diagnosed with and treated for malignancy, Langerhans cell histiocytosis ,or Hemophagocytic lymphohistiocytosis between 2007 through 2010 at Monroe Carrell Jr. Children's Hospital at Vanderbilt under the age of 23 at diagnosis.
Criteria

Inclusion Criteria:

  • Diagnosed with malignancy, Langerhans cell histiocytosis,or hemophagocytic lymphohistiocytosis from 2007 through 2010
  • Under 23 years at time of diagnosis of malignancy, Langerhans cell histiocytosis,or hemophagocytic lymphohistiocytosis
  • Treated at Monroe Carell Jr. Children's Hospital at Vanderbilt for aforementioned diagnosis from 2007 through 2012
  • While on immunosuppressive therapy with a central venous line in place had at least one documented episode of fever (defined as ≥ 38.0°Celsius orally for over 30 minutes or ≥ 38.3°Celsius orally x1).

Exclusion Criteria:

  • Does not meet all inclusion criteria as stated above
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225718


Locations
United States, Tennessee
Monroe Carrell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
  More Information

Responsible Party: Adam Esbenshade, Assistant Professor of Pediatrics, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01225718     History of Changes
Other Study ID Numbers: VICC PED1061
IRB No. 101020
First Submitted: October 15, 2010
First Posted: October 21, 2010
Last Update Posted: April 17, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Histiocytosis
Lymphatic Diseases
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents