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出境医 / 临床实验 / Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Febrile Neutropenia Fever | Other: Interview Other: Survey Administration |
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.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | The Prognostic Value of the Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients |
| Actual Study Start Date : | June 19, 2015 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
Take part in interview
Other: Survey Administration Respond to survey
|
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- 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 ]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.
- 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.
- Percentage of patients with positive blood cultures [ Time Frame: Up to 5 years ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients at the University of Texas MD Anderson Cancer Center
Criteria
Inclusion Criteria:
- Temperature above 38.0 documented.
- Absolute neutrophil count (ANC) < 500/mm^3.
Contacts and Locations
Locations
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Terry W. Rice 713-563-2098 | |
| Principal Investigator: Terry W. Rice | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Terry W Rice | M.D. Anderson Cancer Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 28, 2019 | ||||
| First Posted Date | May 30, 2019 | ||||
| Last Update Posted Date | May 30, 2019 | ||||
| Actual Study Start Date | June 19, 2015 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients | ||||
| Official Title | The Prognostic Value of the Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients | ||||
| 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. | ||||
| 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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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients at the University of Texas MD Anderson Cancer Center | ||||
| Condition |
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| Intervention |
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| Study Groups/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.
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03968328 | ||||
| Other Study ID Numbers | 2015-0272 NCI-2019-02655 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2015-0272 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor | M.D. Anderson Cancer Center | ||||
| Collaborators | National Cancer Institute (NCI) | ||||
| Investigators |
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| PRS Account | M.D. Anderson Cancer Center | ||||
| Verification Date | May 2019 | ||||
