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Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

NCT03788967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1372

Last updated 2022-07-25

Study results available
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Summary

The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).

Conditions

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis

Interventions

DRUG

TBPM-PI-HBr

TBPM-PI-HBr tablets administered orally.

DRUG

Ertapenem

Antibiotic Therapy for cUTI.

DRUG

Dummy Infusion

Dummy intravenous infusion.

DRUG

Dummy tablets

Dummy tablets orally.

Sponsors & Collaborators

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • David Melnick, MD · Spero Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2020-05-20
Completion
2020-05-27
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Moldova
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

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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 NCT03788967 on ClinicalTrials.gov