NCT06059846Phase 3Completed

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)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-01-27Actual

Enrollment · participants1690Actual

Source updated2026-03-10Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-03-10 · 1 field changed

Actual enrollment decreased by 958 participants

− Before

~~2648 participants (actual)~~

+ After

1690 participants (actual)

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Posted 2026-02-12 · 2 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit

+ After

Measure: Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population

Actual enrollment increased by 958 participants

− Before

~~1690 participants (actual)~~

+ After

2648 participants (actual)

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Posted 2025-11-25 · 1 field changed

Primary completion date changed

− Before

~~18 Jan 2025~~

+ After

27 Jan 2025

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Study details

Conditions studied

Urinary Tract Infection; Acute Pyelonephritis

Treatments or interventions studied

TBP-PI-HBrDrugAlso known as SPR994
Imipenem-cilastatinDrug
Dummy InfusionDrug
Dummy TabletsDrug

Primary outcomes · main study measures

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measure: Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population; description: Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.; timeFrame: At Day 17 (TOC)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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