Health TrialsbyHealthPanel

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

ConditionGram-negative Bacteremia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous Antibiotics

    Drug

    Participants will continue to receive intravenous antibiotics until the completion of the treatment course

  • Oral Antibiotics

    Drug

    Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course

Treatment groups

1,030 Participants
are divided into 2 treatment groups
Group A: Intravenous AntibioticsActive comparator 1 intervention
Group B: Oral AntibioticsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
Apply now