Ceftriaxone in Non-neutropenic Fever
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Adam Esbenshade, Vanderbilt University
First received: October 15, 2010
Last updated: June 11, 2013
Last verified: June 2013
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.
Pediatric Patients With Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Ceftriaxone in Non-neutropenic Fever|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Hand-Schuller-Christian Disease Langerhans Cell HistiocytosisU.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.
|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)|
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