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NCT06059846 · ClinicalTrials.gov registry record · Phase 3

A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

A Phase 3 study of Urinary Tract Infection and Acute Pyelonephritis, sponsored by Spero Therapeutics.

Completed
Registry status
Phase 3
Development phase
1,690
Enrollment target
20
Study locations

NCT06059846 is a Phase 3 study of Urinary Tract Infection and Acute Pyelonephritis that has completed, run by Spero Therapeutics. The registered enrollment target is 1,690 participants, above the 520-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (225% higher). The trial reports 20 study locations across 2 states.

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The verdict

NCT06059846, a Phase 3 study of Urinary Tract Infection and Acute Pyelonephritis, has completed, sponsored by Spero Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
1,690 participants
Enrollment target
20
Study locations

Study Summary

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (greater than or equal to (≥)18 years of age) with cUTI or AP.

Conditions Studied

Urinary Tract Infection Acute Pyelonephritis

Interventions

  • DRUG TBP-PI-HBr
  • DRUG Imipenem-cilastatin
  • DRUG Dummy Infusion
  • DRUG Dummy Tablets

Study Locations (20)

Other

  • Medical Facility - Buenos Aires
  • Medical Facility - Córdoba
  • Medical Facility - La Plata
  • Medical Facility - Mendoza
  • Medical Facility - San Miguel de Tucumán
  • Medical Facility - Villa Regina
  • Medical Facility - Banja Luka
  • Medical Facility - Sarajevo
  • Medical Facility - Tuzla
  • Medical Facility - Barueri
  • Medical Facility - Campinas
  • Medical Facility - Curitiba
  • Medical Facility - Porto Alegre
  • Medical Facility - São José do Rio Preto
  • Medical Facility - Blagoevgrad
  • Medical Facility - Dobrich
  • Medical Facility - Gabrovo
  • Medical facility - Lom

Florida

  • Medical facility - Miami
  • Medical Facility - Miami

Trial Details

FieldValue
Enrollment Target 1,690 participants
Start Date 2023-12-21
Est. Completion 2025-02-06
Phase Phase 3

Sponsor

Spero Therapeutics

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06059846

The ClinicalTrials.gov registry entry for NCT06059846 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,690 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 520-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (225% higher). The listed sponsor is Spero Therapeutics, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Urinary Tract Infection appearing as the primary indexed condition, and to 4 interventions - of which TBP-PI-HBr is the first listed.

NCT06059846 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, Florida.

Frequently Asked Questions

What is clinical trial NCT06059846 about?

NCT06059846 is a clinical study titled "A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)". The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (grea...

What is the current status of trial NCT06059846?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,690 participants. The study started on 2023-12-21. Estimated completion is 2025-02-06.

What conditions does trial NCT06059846 study?

This clinical trial studies the following conditions: Urinary Tract Infection, Acute Pyelonephritis.

What interventions are being tested in trial NCT06059846?

The interventions under investigation include: TBP-PI-HBr (DRUG), Imipenem-cilastatin (DRUG), Dummy Infusion (DRUG), Dummy Tablets (DRUG).

Who is sponsoring clinical trial NCT06059846?

This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06059846 being conducted?

This trial has 20 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.