Antibiotic Concentrations After Massive Transfusion Study

This study, called the Antibiotic Concentrations After MassivE Transfusion Study, is looking at how blood transfusions might change the levels of antibiotics in your body if you've experienced a trauma. Researchers want to understand if receiving a lot of blood (a "massive transfusion") affects how well antibiotics like ampicillin/sulbactam, cefazolin, or others work. They will measure the amount of these antibiotics in your blood over the first 18 hours after you receive them. This study is for trauma patients aged 18 and older who are receiving one of the listed antibiotics and are either hospitalized or expected to be. The goal is to see how much of the drug is present in your blood. The current recruitment status is unclear, but the study plans to enroll 417 participants.

Study design
This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. It will compare trauma patients who receive a lot of blood transfusions to those who receive minimal or no transfusions.
What's involved
If you participate, blood samples (about 1mL each) will be collected at six specific times after you receive antibiotics. These collections will often happen at the same time as other blood draws to minimize extra needle sticks.
Compensation
Not stated in the trial record.
Follow-up
Your drug concentrations will be measured within the first 18 hours, and data will be collected until 30 days after your initial enrollment.

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NCT06699901

Antibiotic Concentrations After MassivE Transfusion Study

Recruiting
Not specifiedAges 18+Observational
Brooke Army Medical Center
~417 participants
Updated 2025-02-11 on ClinicalTrials.gov
What's tested:Massive Transfusion GroupControl Group

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amount of drug concentrations within first 18 hours.
Measured over From initial enrollment until 30 days after.
Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents
2 sites across 2 states
Colorado1
Texas1
  • Julie A Rizzo, MD · PRINCIPAL_INVESTIGATOR · Brooke Army Medical Center

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Eligibility criteria

Inclusion

Receives ampicillin/sulbactam, cefazolin, cefepime, ceftriaxone, clindamycin, ertapenem, levofloxacin, metronidazole or pipercillin/tazobactam at any dose
Hospitalized or anticipated hospital admission

Exclusion

Received the same antibiotic within the past 5 half-lives of the drug (e.g. received the same antibiotic during a recent interval)
\<18 years of age
Known pregnancy
Known Prisoner
  • Amount of drug concentrations within first 18 hours.From initial enrollment until 30 days after.

    Obtain drug concentrations at regular intervals during the first 18 hours after antibiotic administration.