Ceftriaxone in Non-neutropenic Fever
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2013 by Vanderbilt University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Vanderbilt University
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
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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 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 (Child, Adult) |
| 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
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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
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
| 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 |
Additional relevant MeSH terms:
|
Histiocytosis Lymphatic Diseases Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 30, 2016