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Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

NCT03358576 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 674

Last updated 2020-12-01

Study results available
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Summary

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.

Conditions

  • Intra Abdominal Infections

Interventions

DRUG

Ertapenem

Antibiotic for complicated intra-abdominal infection

DRUG

Sulopenem-Etzadroxil/Probenecid

Antibiotic for complicated intra-abdominal infection

DRUG

Ciprofloxacin

Antibiotic for complicated intra-abdominal infection

DRUG

Metronidazole

Antibiotic for complicated intra-abdominal infection

DRUG

Amoxicillin-Clavulanate

Antibiotic for complicated intra-abdominal infection

DRUG

Sulopenem

Antibiotic for complicated intra-abdominal infection

Sponsors & Collaborators

  • Iterum Therapeutics, International Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-10-02
Completion
2019-10-02
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03358576 on ClinicalTrials.gov