Gram-negative BacteremiaGOATNCT06080698
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
A study testing Intravenous Antibiotics and Oral Antibiotics in people with Gram-negative Bacteremia, run by Johns Hopkins University at 11 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-negative Bacteremia
- What is being tested?
- Intravenous Antibiotics and Oral Antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Feb 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 maltophilia), (2) a single positive blood culture with a common commensal organism (grown in addition to an Enterobacterales species or Pseudomonas aeruginosa
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- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21202
Anthony Harris, aharris@som.umaryland.edu
Michelle Newan, mnewman@som.umaryland.edu
- Recruiting
Johns Hopkins University Hospital Systems
Baltimore, Maryland, 21287
Sara Cosgrove, 443-287-4570, scosgro1@jhmi.edu
Alyssa Cavezza, acavezz1@jh.edu
- Recruiting
Denver Health Hospital Authority
Denver, Colorado, 80204
Timothy Jerkins, MD, timothy.jenkins@dhha.org
Judy Oakes, judy.oakes@dhha.org
- Recruiting
Duke University
Durham, North Carolina, 27710
Joshua Thaden, MD, joshua.thaden@duke.edu
Laura Farrow, laura.farrow@duke.edu
- Recruiting
Houston Methodist
Houston, Texas, 77030
William L Musick, Pharm D, 281-222-9983, mwadelman@houstonmethodist.org
Jennifer Garrett, jmgarrett@houstonmethodist.org
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
George Nelson, MD, george.nelson@vumc.org
Marina Khalil, marina.khalil@vumc.org
- Recruiting
Rutgers-RWJ University Hospital
New Brunswick, New Jersey, 08901
Keith Kaye, MD, kk1116@rwjms.rutgers.edu
Swati Kumar, sk2280@rwjms.rutgers.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Lauren Dutcher, MD, dutcherl@pennmedicine.upenn.edu
Pam Tolomeo, tolomeop@pennmedicine.upenn.edu
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24011
Lana Wahid, 757-509-8162, lwahid@carilionclinic.org
Parisa Farahani, pfarahani@carlionclinic.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Gina Suh, MD, suh.gina@mayo.edu
Jacob Bjerke, bjerke.jacob@mayo.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Sarah Doernberg, MD, sarah.doernberg@ucsf.edu
Mahroo Safaei, mahroo.safaei@ucsf.edu
About this study
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.
Read the detailed description
This is an open-label, pragmatic, randomized trial of approximately 1,204 adult patients hospitalized across 9 United States hospitals with the overarching goal of determining whether the optimal approach for the management of GN-BSI is (1) IV antibiotics for the duration of treatment or (2) initial IV antibiotics followed by early transition to oral antibiotics for the duration of treatment. Patients will be randomized in a 1:1 ratio to remain on IV antibiotics or transition to oral antibiotics as soon as possible after blood culture collection, but no more than 5 days later. The primary objective is to compare the Desirability of Outcomes Ranking (DOOR) distributions between patients with GN-BSI receiving IV antibiotic treatment only versus patients transitioned early to oral antibiotic treatment. The study hypothesis is that oral treatment will result in a more favorable DOOR distribution than IV treatment, likely as a result of differential adverse events and changes in Quality of Life (QoL) profiles.
- Conditions
- Gram-negative Bacteremia
- Being tested
- Intravenous Antibiotics, Oral Antibiotics
- Keywords
- Gram-negative bacteremia, Antibiotic treatment, Antibiotic route, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Desirability of outcome ranking (DOOR)
- Medical subject headings
- Escherichia coli Infections, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous AntibioticsDrug
Participants will continue to receive intravenous antibiotics until the completion of the treatment course
Oral AntibioticsDrug
Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Antibiotics | Active comparator | IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem. Receives: Drug: Intravenous Antibiotics |
| Oral Antibiotics | Active comparator | Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole. Receives: Drug: Oral Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desirability of Outcome Ranking (DOOR)
Each participant will be placed in 1 of 5 DOOR levels based on overall clinical response and treatment-related adverse events (AE). The 5 DOOR levels are as follows: successful clinical response and no treatment-related AE (Level 1); mild suboptimal clinical response or mild treatment-related AE (Level 2); moderate suboptimal clinical response or moderate treatment-related AE (Level 3); significant suboptimal clinical response or significant treatment-related AE (Level 4); death (Level 5). The distribution of participants in the five DOOR levels will be used to ultimately determine which treatment approach is superior for the management of GN-BSI (i.e., IV antibiotic treatment or early transition to oral antibiotic treatment).
Measured: Day 30
Secondary outcomes (4)
Incidence of All Cause Mortality
30-day all cause mortality will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Measured: Day 30
Frequency of Recurrent infection
30-day recurrent infection with the same bacterial species will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Measured: Day 30
Length of stay (days)
Hospital length of stay will be compared between adults with GN-BSI alive at day 30 receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Measured: Day 30
Number of Participants with Treatment-related adverse events
Moderate to severe treatment-related AEs will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start22 Feb 2024
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-negative BacteremiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants with GN-BSI will be randomized to (arm 1) IV antibiotics or (arm 2) oral antibiotics for the treatment of GN-BSI.
- Masking
- None (open label)
- Enrolment
- 1,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Pranita D Tamma, MD, MHS, Principal investigator, Children's Hospital of PhiladelphiaSara E Cosgrove, MD, MS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080698
- Sponsor's protocol ID
- IRB00390397
- Other IDs
- CER-2022C1-26099
- Acronym
- GOAT
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
- ClinicalTrials.gov ID
- NCT06080698
- Acronym / sponsor ID
- GOAT / IRB00390397
- Conditions
- Gram-negative Bacteremia
- Keywords
- Gram-negative bacteremia, Antibiotic treatment, Antibiotic route, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Desirability of outcome ranking (DOOR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,030 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, pragmatic, randomized trial of approximately 1,204 adult patients hospitalized across 9 United States hospitals with the overarching goal of determining whether the optimal approach for the management of GN-BSI is (1) IV antibiotics for the duration of treatment or (2) initial IV antibiotics followed by early transition to oral antibiotics for the duration of treatment. Patients will be randomized in a 1:1 ratio to remain on IV antibiotics or transition to oral antibiotics as soon as possible after blood culture collection, but no more than 5 days later. The primary objective is to compare the Desirability of Outcomes Ranking (DOOR) distributions between patients with GN-BSI receiving IV antibiotic treatment only versus patients transitioned early to oral antibiotic treatment. The study hypothesis is that oral treatment will result in a more favorable DOOR distribution than IV treatment, likely as a result of differential adverse events and changes in Quality of Life (QoL) profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants with GN-BSI will be randomized to (arm 1) IV antibiotics or (arm 2) oral antibiotics for the treatment of GN-BSI.
| Arm | Type | Receives |
|---|---|---|
| Intravenous Antibiotics | Active comparator | Drug: Intravenous AntibioticsIV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem. |
| Oral Antibiotics | Active comparator | Drug: Oral AntibioticsOral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous AntibioticsParticipants will continue to receive intravenous antibiotics until the completion of the treatment course | Drug | Intravenous Antibiotics |
| Oral AntibioticsParticipants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course | Drug | Oral Antibiotics |
Primary outcome
Desirability of Outcome Ranking (DOOR)
Time frame: Day 30
Each participant will be placed in 1 of 5 DOOR levels based on overall clinical response and treatment-related adverse events (AE). The 5 DOOR levels are as follows: successful clinical response and no treatment-related AE (Level 1); mild suboptimal clinical response or mild treatment-related AE (Level 2); moderate suboptimal clinical response or moderate treatment-related AE (Level 3); significant suboptimal clinical response or significant treatment-related AE (Level 4); death (Level 5). The distribution of participants in the five DOOR levels will be used to ultimately determine which treatment approach is superior for the management of GN-BSI (i.e., IV antibiotic treatment or early transition to oral antibiotic treatment).
4 secondary outcomes
Incidence of All Cause Mortality
Time frame: Day 30
Frequency of Recurrent infection
Time frame: Day 30
Length of stay (days)
Time frame: Day 30
Number of Participants with Treatment-related adverse events
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pranita D Tamma, MD, MHS principal investigator
Children's Hospital of Philadelphia
Sara E Cosgrove, MD, MS principal investigator
Johns Hopkins University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Antibiotics and Oral Antibiotics in people with Gram-negative Bacteremia, run by Johns Hopkins University at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pranita D Tamma, MD, MHS (410-614-1492, tammap1@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desirability of Outcome Ranking (DOOR) (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.