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NCT05045963 Clinical Trial

Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

Malignant Solid Neoplasm Clinical Trial

Official title:
Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05045963
Other study ID # 2020-0999
Secondary ID NCI-2021-0110520
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date July 2, 2025

Study information
Verified date November 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 319
Est. completion date July 2, 2025
Est. primary completion date July 2, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electronic Health Record Review
Medical record reviewed

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to resolution of hypotension Defined as a mean arterial pressure > 65 mmHg not requiring vasopressors and sustained for >= 24 hours. Within 7 days from hypotension onset
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