Febrile NeutropeniaNCT03968328
Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
An observational study of Febrile Neutropenia and Fever, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia, Fever
- What is being tested?
- Interview and Survey Administration
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2015to 17 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at the University of Texas MD Anderson Cancer Center
Who may be able to join
None listed.
Who cannot join
- --Age <18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognostic Value of the 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Febrile Neutropenia, Fever
- Being tested
- Interview, Survey Administration
- Medical subject headings
- Febrile Neutropenia, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Take part in interview
Survey AdministrationOther
Respond to survey
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 14 days
Secondary outcomes (5)
Cause specific death
Measured: Up to 5 years
Intensive care unit (ICU) admission rate
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Percentage of patients with positive blood cultures
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start19 Jun 2015
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sai-ching Yeung, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968328
- Sponsor's protocol ID
- 2015-0272
- Other IDs
- NCI-2019-02655, 2015-0272
- Status last verified
- Jul 2023
- First submitted
- 28 May 2019
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of the Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
- ClinicalTrials.gov ID
- NCT03968328
- Acronym / sponsor ID
- 2015-0272
- Conditions
- Febrile Neutropenia, Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (interview, survey) | – | Other: Interview, Other: Survey AdministrationPatients respond to a survey and participate in an interview with study staff about their fever and when they started feeling unwell. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the University of Texas MD Anderson Cancer Center
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- --Age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewTake part in interview | Other | Observational (interview, survey) |
| Survey AdministrationRespond to survey | Other | Observational (interview, survey) |
Primary outcome
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.
5 secondary outcomes
Cause specific death
Time frame: Up to 5 years
Intensive care unit (ICU) admission rate
Time frame: Up to 5 years
ICU length of stay
Time frame: Up to 5 years
Length of hospitalization
Time frame: Up to 5 years
Percentage of patients with positive blood cultures
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sai-ching Yeung, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia and Fever, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14 day cause specific mortality rate (time frame: At 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.