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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03968328
Other study ID # 2015-0272
Secondary ID NCI-2019-0265520
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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