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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03968328
Enrollment
315
Registered
2019-05-30
Start date
2015-06-19
Completion date
2023-01-17
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Fever

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.

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.

Interventions

OTHERInterview

Take part in interview

OTHERSurvey Administration

Respond to survey

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

IInclusion criteria: --\> 18 years of age * Temperature above 38.0 documented * ANC\< 500/mm3

Exclusion criteria

--Age \<18

Design outcomes

Primary

MeasureTime frameDescription
14 day cause specific mortality rateAt 14 daysWill 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

MeasureTime frameDescription
Cause specific deathUp to 5 years
Intensive care unit (ICU) admission rateUp to 5 years
ICU length of stayUp to 5 yearsLinear 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.
Length of hospitalizationUp to 5 yearsLinear regression model will be used to assess the multivariate relationship between time to antibiotic administration, patient demographic and clinical characteristics with length of hospitalization.
Percentage of patients with positive blood culturesUp to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026