Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

NCT ID: NCT05045963

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

319 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-04

Study Completion Date

2025-09-21

Brief Summary

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This study evaluates the impact of aminoglycosides in hypotensive septic oncologic patients. In the oncologic patient population, sepsis is a major health concern due to high mortality rates and healthcare costs. Prior research shows aminoglycosides antibiotics are frequently used to treat sepsis, but their clinical impact in hypotensive oncology patients upon the progression of sepsis is not known.

Detailed Description

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PRIMARY OBJECTIVE:

I. To assess the impact of beta-lactam (BL) + aminoglycoside (AG) combination therapy in hypotensive septic oncology patients.

OUTLINE:

Patients' medical charts are reviewed retrospectively.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Septicemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational (medical record review)

Patients' medical charts are reviewed retrospectively.

Electronic Health Record Review

Intervention Type OTHER

Medical record reviewed

Interventions

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Electronic Health Record Review

Medical record reviewed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age \>= 18 years) with a diagnosis of sepsis during the index hospital admission identified by International classification of diseases (ICD)-10 codes (as specified below) receiving BL antibiotics within 6 hours prior to or following the onset of hypotension
* To be included in the AG group, patients must have received at least 1 dose of intravenous (IV) tobramycin or amikacin in addition to the BL therapy within the above time period

Exclusion Criteria

* Age \< 18 years
* Receipt of IV AG outside of the above time frame in the AG group or receipt of IV AG within 48 hours prior to or following the onset of hypotension in the BL backbone group
* Pregnancy
* Patients not receiving therapy with BL antibiotics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey J Bruno

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeffrey J Bruno

Role: CONTACT

713-792-0251

Facility Contacts

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Jeffrey J. Bruno

Role: primary

713-792-0251

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center

Other Identifiers

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NCI-2021-01105

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0999

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0999

Identifier Type: -

Identifier Source: org_study_id

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