HistiocytosisNCT01225718
Ceftriaxone in Non-neutropenic Fever
An observational study of Histiocytosis and Pediatric Patients With Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Histiocytosis, Pediatric Patients With Cancer
- How many people
- 463 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 25 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- Does not meet all inclusion criteria as stated above
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carrell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
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.
- Conditions
- Histiocytosis, Pediatric Patients With Cancer
- Medical subject headings
- Histiocytosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startAug 2010
- Primary completion25 Jun 2016
- Study completion25 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistiocytosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Esbenshade, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225718
- Sponsor's protocol ID
- VICC PED1061
- Other IDs
- IRB No. 101020
- Status last verified
- Apr 2017
- First submitted
- 15 Oct 2010
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceftriaxone in Non-neutropenic Fever
- ClinicalTrials.gov ID
- NCT01225718
- Acronym / sponsor ID
- VICC PED1061
- Conditions
- Histiocytosis, Pediatric Patients With Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 25 Jun 2016 (actual)
- Study completion
- 25 Jun 2016 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Does not meet all inclusion criteria as stated above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Histiocytosis and Pediatric Patients With Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.