An interventional study of Intravenous Antibiotics and Oral Antibiotics in Gram-negative Bacteremia, sponsored by Johns Hopkins University. Recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Among 38 studies in Escherichia coli Infections with a site in United States — 7 open to participants now, 7 under way, none of them phase 3. Escherichia coli Infections · United States.
Among the 38 studies in Escherichia coli Infections with a site in United States, this one is the 2nd largest by planned enrollment of the 29 interventional ones that give a count, is one of 3 that started in 2024, is one of 6 with no phase, and was the 33rd registered.
99 studies on the registry are indexed under Escherichia coli Infections; 21 are open to participants now.
Browse Escherichia coli Infections studies →7 of the 38 studies in Escherichia coli Infections with a site in United States are open now. Recruiting first, the newest first:
Oregon Health and Science University · Sites in United States
Barbara Trautner · Sites in United States
SNIPR Biome Aps. · Sites in United States
GlaxoSmithKline · Sites in United States, South Africa
University of Calgary · Sites in United States, Canada
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Escherichia coli Infections studies recruiting now, 7 (54%) set no upper age limit and 5 (38%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 7 · Phase 3 2
First in 1997; this study’s year is marked. 3 started in 2024.
This study's planned enrollment of 1,030 is above the median of 72 across 63 interventional studies indexed under Escherichia coli Infections.
Median enrollment 65 across the 29 interventional studies, 200 across the 9 observational. Of the 30 that completed or were terminated, 10 (33%) have results posted.
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7 of 38 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 1 study filed under Escherichia coli Infections — fewer than ten, so there is no comparison to draw.
6 of the studies in Escherichia coli Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06702449GlaxoSmithKlineA Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age | 2027-05-31 |
| NCT06080698Johns Hopkins UniversityGram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial | 2027-05-31 |
| NCT05488340Locus BiosciencesA Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) | 2027-06 |
| NCT05219110University of CalgaryHyperhydration in Children With Shiga Toxin-Producing E. Coli Infection | 2027-08-31 |
| NCT06559618Barbara TrautnerBacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria | 2027-09 |
Among the 38 studies in Escherichia coli Infections with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Polymicrobial bloodstream infection
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.
Drug: Intravenous Antibiotics
Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.
Drug: Oral Antibiotics
Participants will continue to receive intravenous antibiotics until the completion of the treatment course
Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course
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).
Time frame: Day 30
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 30
Started Feb 2024 (actual). Primary completion is estimated for May 2027, 39 months after the start.
How these figures are worked out, and which studies are left out of them.
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