Ceftriaxone in Non-neutropenic Fever

Histiocytosis Clinical Trial

Official title:

Ceftriaxone in Non-neutropenic Fever

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225718
• Other study ID #: VICC PED1061
• Secondary ID: IRB No. 101020
• Status: Completed
• Phase: N/A
• First received: October 15, 2010
• Last updated: April 13, 2017
• Start date: August 2010
• Est. completion date: June 25, 2016

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: June 25, 2016
• Est. primary completion date: June 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Histiocytosis
• Pediatric Patients With Cancer

Locations

Country	Name	City	State
United States	Monroe Carrell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months
Secondary	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.	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.	12 months
Secondary	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	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.	12 months