Evaluating aminoglycosides in septic oncology patients with low blood pressure
Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients
This study is testing if combining aminoglycoside antibiotics with beta-lactam therapy can help adult cancer patients with low blood pressure caused by sepsis feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 319 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05045963 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the effects of aminoglycoside antibiotics combined with beta-lactam therapy in adult oncology patients experiencing hypotension due to sepsis. By reviewing electronic health records, the study aims to understand the clinical impact of this combination therapy on patient outcomes. The focus is on patients diagnosed with sepsis during their hospital stay, specifically those who received beta-lactam antibiotics within a critical time frame. The findings could provide insights into optimizing treatment strategies for this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are adult oncology patients aged 18 and older who develop sepsis and receive beta-lactam antibiotics during their hospital admission.
Not a fit: Patients under 18 years old, pregnant women, or those not receiving beta-lactam antibiotics will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment protocols for hypotensive septic oncology patients, potentially reducing mortality rates.
How similar studies have performed: While aminoglycosides have been used in sepsis treatment, the specific impact on hypotensive oncology patients is not well-established, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey J Bruno — M.D. Anderson Cancer Center
- Study coordinator: Jeffrey J Bruno
- Email: jjbruno@mdanderson.org
- Phone: 713-792-0251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.