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New treatment option for Gram-negative Bacteremia
Official title Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
ClinicalTrials.gov ID: NCT06080698
What this study is testing
What is Intravenous Antibiotics?
Intravenous Antibiotics is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gram-negative bacteremia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomized clinical trial that hypothesizes that early transition to oral antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is as effective but safer than remaining on intravenous (IV) antibiotic therapy for the duration of treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult (≥ 18 years) at the time of screening
- Hospitalized
- Identification of at least one Gram-negative organism in a blood culture
- Capable of providing written informed consent (includes through a legally authorized representative)
- Willingness to adhere to assigned study arm
You likely can't join if
- Unable to tolerate or absorb a course of oral antibiotics
- Actively receiving vasopressors
- Gram-negative organism not susceptible to any oral antibiotics
- Gram-negative organism not susceptible to any IV antibiotics
- Polymicrobial bloodstream infection
- The following patients with polymicrobial infections remain eligible for enrollment: (1) more than one morphology or species of a gram-negative...
See the full eligibility criteria
- Adult (≥ 18 years) at the time of screening
- Hospitalized
- Identification of at least one Gram-negative organism in a blood culture
- Capable of providing written informed consent (includes through a legally authorized representative)
- Willingness to adhere to assigned study arm
- Capable and willing to complete a follow-up QoL interview (including through a legally authorized representative)
- Unable to tolerate or absorb a course of oral antibiotics
- Actively receiving vasopressors
- Gram-negative organism not susceptible to any oral antibiotics
- Gram-negative organism not susceptible to any IV antibiotics
- Polymicrobial bloodstream infection
- The following patients with polymicrobial infections remain eligible for enrollment: (1) more than one morphology or species of a gram-negative organism (except for Acinetobacter baumannii or Stenotrophomonas...
- Allergy or contraindication rendering no oral option or no IV option for therapy with the listed antibiotic agents.
- Anticipated duration of therapy greater than 14 days
- Central nervous system infection
- Absolute neutrophil count of \<500 cells/mL or anticipated to reduce to \<500 cells/mL during the antibiotic treatment course.
- Receiving hospice care
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Denver, Colorado, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- New Brunswick, New Jersey, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Roanoke, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Denver, Colorado, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; New Brunswick, New Jersey, United States; Durham, North Carolina, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.