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

NCT03968328 | Completed

• 2 other identifiers: 2015-0272NCI-2019-02655
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Neutropenia; Fever

Outcome Measures

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.

  At 14 days

Secondary Outcomes (5)

• Cause specific death

  Up to 5 years

• Intensive care unit (ICU) admission rate

  Up to 5 years

• ICU length of stay

  Up to 5 years

• Length of hospitalization

  Up to 5 years

• Percentage of patients with positive blood cultures

  Up to 5 years

Study Arms (1)

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

Interview OTHER

Take part in interview

Observational (interview, survey)

Survey Administration OTHER

Respond to survey

Observational (interview, survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the University of Texas MD Anderson Cancer Center

You may qualify if:

• \> 18 years of age
• Temperature above 38.0 documented
• ANC\< 500/mm3

You may not qualify if:

• Age \<18

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Febrile Neutropenia; Fever

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sai-ching Yeung, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: June 19, 2015
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (1)