Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Conditions

• Gram-negative Bacteremia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Feb 22, 2024

Status verified

Mar 2026

Primary completion

May 31, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

1,030 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Intravenous Antibiotics
  IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.
• Active Comparator: Oral Antibiotics
  Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.

Primary Outcome Measure

Desirability of Outcome Ranking (DOOR) [ Time Frame: Day 30 ]

Central Contacts

• Pranita D Tamma, MD, MHS
  410-614-1492
  [email protected]
• Sara E Cosgrove, MD, MS
  443-287-4570
  [email protected]

Locations (11)

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