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Ceftriaxone in Non-neutropenic Fever

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Adam Esbenshade, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01225718
First received: October 15, 2010
Last updated: June 11, 2013
Last verified: June 2013
History of Changes
  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:

MedlinePlus related topics: Fever
Drug Information available for: Ceftriaxone
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
Estimated Enrollment: 360
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   up to 22 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225718

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

No publications provided

Responsible Party: Adam Esbenshade, Assistant Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01225718     History of Changes
Other Study ID Numbers: VICC PED1061, IRB No. 101020
Study First Received: October 15, 2010
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015