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CompletedNCT03968328Updated Jul 21, 2023

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

An observational study in Febrile Neutropenia and Fever, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
315
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Febrile Neutropenia
  • Fever
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In context

Febrile Neutropenia

155 studies on the registry are indexed under Febrile Neutropenia; 32 are open to participants now.

This study's enrollment of 315 is above the median of 132 across 57 observational studies indexed under Febrile Neutropenia.

Browse Febrile Neutropenia studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.

Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients at the University of Texas MD Anderson Cancer Center

Eligibility criteria

IInclusion criteria:

--> 18 years of age

  • Temperature above 38.0 documented
  • ANC\< 500/mm3

Exclusion Criteria:

--Age \<18

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
315 participants (actual)

Groups and cohorts

  • 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 · Other: Survey Administration

Interventions

  • OtherInterview

    Take part in interview

  • OtherSurvey Administration

    Respond to survey

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 14 days

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

    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.

    Time frame: Up to 5 years

  4. 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.

    Time frame: Up to 5 years

  5. Percentage of patients with positive blood cultures

    Time frame: Up to 5 years

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Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03968328
Responsible party
Sponsor
First posted
May 30, 2019
Start date
Jun 19, 2015
Primary completion
Jan 17, 2023
Completion
Jan 17, 2023
Last update
Jul 21, 2023

Study contacts

Sai-ching Yeung, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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