Ceftriaxone in Non-neutropenic Fever

NCT ID: NCT01225718

Last Updated: 2017-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

463 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Histiocytosis Pediatric Patients With Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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).
Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adam Esbenshade

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Monroe Carrell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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IRB No. 101020

Identifier Type: -

Identifier Source: secondary_id

VICC PED1061

Identifier Type: -

Identifier Source: org_study_id

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