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Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients

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ClinicalTrials.gov Identifier: NCT03968328
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial uses an interview and a survey to gather information from cancer patients about the onset of their fever and the administration of antibiotics. Collecting information from patients may help doctors to assess the relationship between time to antibiotic administration and inhospital cause specific death, intensive care unit admission, hospital length of stay, and positive blood cultures.

Condition or disease Intervention/treatment
Febrile Neutropenia Fever Other: Interview Other: Survey Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the prognostic value of the length of time between the time onset of fever and first antibiotic administration on cause specific 14 day mortality rate.

SECONDARY OBJECTIVES:

I. To assess the associations of the length of time between the time onset of fever and first antibiotic administration with intensive care unit (ICU) admission, ICU length of stay, length of hospitalization and percentage of patients with positive blood cultures.

OUTLINE:

Patients respond to a survey and participate in an interview with study staff about their fever and when they started feeling unwell.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Prognostic Value of the Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
Actual Study Start Date : June 19, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Group/Cohort Intervention/treatment
Observational (interview, survey)
Patients respond to a survey and participate in an interview with study staff about their fever and when they started feeling unwell.
Other: Interview
Take part in interview

Other: Survey Administration
Respond to survey




Primary Outcome Measures :
  1. 14 day cause specific mortality rate [ Time Frame: At 14 days ]
    Will perform univariate logistic regression analysis to assess the effect of time to antibiotic administration on death 14 days post fever onset. Will build multivariate logistic regression model(s) to further assess the effect of time to antibiotic administration on death 14 days post fever onset adjusting for other potential confounders.


Secondary Outcome Measures :
  1. Cause specific death [ Time Frame: Up to 5 years ]
  2. Intensive care unit (ICU) admission rate [ Time Frame: Up to 5 years ]
  3. ICU length of stay [ Time Frame: Up to 5 years ]
    Linear regression model will be used to assess the multivariate relationship between time to antibiotic administration, patient demographic and clinical characteristics with ICU length of stay.

  4. Length of hospitalization [ Time Frame: Up to 5 years ]
    Linear regression model will be used to assess the multivariate relationship between time to antibiotic administration, patient demographic and clinical characteristics with length of hospitalization.

  5. Percentage of patients with positive blood cultures [ Time Frame: Up to 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the University of Texas MD Anderson Cancer Center
Criteria

Inclusion Criteria:

  • Temperature above 38.0 documented.
  • Absolute neutrophil count (ANC) < 500/mm^3.

Information from the National Library of Medicine

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): NCT03968328


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Terry W. Rice    713-563-2098      
Principal Investigator: Terry W. Rice         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Terry W Rice M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03968328     History of Changes
Other Study ID Numbers: 2015-0272
NCI-2019-02655 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0272 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Fever
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents