Ceftriaxone in Non-neutropenic Fever
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|ClinicalTrials.gov Identifier: NCT01225718|
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : April 17, 2017
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 or disease|
|Histiocytosis Pediatric Patients With Cancer|
|Study Type :||Observational|
|Actual Enrollment :||463 participants|
|Official Title:||Ceftriaxone in Non-neutropenic Fever|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 25, 2016|
|Actual Study Completion Date :||June 25, 2016|
- 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 ]
- 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.
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
|United States, Tennessee|
|Monroe Carrell Jr. Children's Hospital at Vanderbilt|
|Nashville, Tennessee, United States, 37232|