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

The Prognostic Value of the Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients

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.

Study Overview

• Status: Completed
• Conditions: Fever; Febrile Neutropenia
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at the University of Texas MD Anderson Cancer Center

Description

IInclusion criteria:

--> 18 years of age

• Temperature above 38.0 documented
• ANC< 500/mm3

Exclusion Criteria:

--Age <18

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
14 day cause specific mortality rate	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.	At 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cause specific death		Up to 5 years
Intensive care unit (ICU) admission rate		Up to 5 years
ICU length of stay	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.	Up to 5 years
Length of hospitalization	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.	Up to 5 years
Percentage of patients with positive blood cultures		Up to 5 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sai-ching Yeung, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2015
• Primary Completion (Actual): January 17, 2023
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Neutropenia; Fever; Febrile Neutropenia
• Other Study ID Numbers: 2015-0272 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02655 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No