Clinical Trials Logo
  1. Home
  2. Malignant Solid Neoplasm
  3. NCT05045963
  4. Details
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 May 2024
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
See also
  Status Clinical Trial Phase
Recruiting NCT06030427 - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT05660421 - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors Phase 2
Suspended NCT04060849 - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY Phase 1
Recruiting NCT06192875 - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed NCT04122118 - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor N/A
Active, not recruiting NCT04940299 - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma Phase 2
Active, not recruiting NCT03168737 - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients Phase 1
Active, not recruiting NCT06062901 - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors N/A
Active, not recruiting NCT02444741 - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT04081298 - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors N/A
Active, not recruiting NCT04555837 - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer Phase 1/Phase 2
Completed NCT04983901 - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN Phase 2
Active, not recruiting NCT04602026 - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer N/A
Recruiting NCT04871542 - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting NCT04592250 - Financial Toxicity in Cancer Patients
Recruiting NCT05112614 - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting NCT04296305 - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain Phase 4
Recruiting NCT05873608 - Communication Issues in Patient and Provider Discussions of Immunotherapy N/A
Recruiting NCT02464696 - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure N/A

External Links