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

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968328
• Other study ID #: 2015-0272
• Secondary ID: NCI-2019-0265520
• Status: Completed
• Start date: June 19, 2015
• Est. completion date: January 17, 2023

Study information

• Verified date: July 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

IInclusion criteria:

--> 18 years of age

• Temperature above 38.0 documented
• ANC< 500/mm3 Exclusion Criteria: --Age <18

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia

Intervention

Other:
• Interview
Take part in interview
• Survey Administration
Respond to survey

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cause specific death		Up to 5 years
Secondary	Intensive care unit (ICU) admission rate		Up to 5 years
Secondary	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
Secondary	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
Secondary	Percentage of patients with positive blood cultures		Up to 5 years

External Links

•   MD Anderson Cancer Center