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NCT Number: NCT03968328

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.

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Key information

Conditions

Febrile Neutropenia Agranulocytosis Body Temperature Changes Cytopenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

IInclusion criteria:

--> 18 years of age

  • Temperature above 38.0 documented
  • ANC< 500/mm3

Exclusion criteria

--Age <18

Treatment and study plan

interview

Other

Take part in interview

Survey Administration

Other

Respond to survey

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
May 30, 2019
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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