Trial · NCT06059846
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)
NCT06059846, Phase 3, Completed, Spero Therapeutics; results first posted 2026-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT06059846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06059846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT06059846
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,690 participants, actual
- Lead sponsor
- Spero Therapeutics
- Conditions
- Urinary Tract Infection, Acute Pyelonephritis
- Interventions
- TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion, Dummy Tablets
- First posted
- 2023-09-29
- Last updated
- 2026-03-10
- Results first posted
- 2026-03-10
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | At Day 17 (TOC) | 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. |
| Secondary | Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population | At Day 17 (TOC) | 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. |
| Secondary | Number of Participants With Overall Response at the End-of-Treatment (EOT) and Late Follow-Up (LFU) Visits in the Micro-ITT Population | At Day 10 (EOT) and Day 28 (LFU) | 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. |
| Secondary | Number of Participants With Overall Response at EOT and LFU Visits in the ME Population | At Day 10 (EOT) and Day 28 (LFU) | 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. |
| Secondary | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the Micro-ITT Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse. |
| Secondary | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the CE Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse. |
| Secondary | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the ME Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse. |
| Secondary | Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the Micro-ITT Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, defined as reduction of Baseline uropathogens to \<10\^3 CFU/mL on urine culture and negative repeated blood culture (if blood culture was positive at Baseline) ;Persistence, defined as Isolation from urine culture of ≥10\^3 CFU/mL or from blood of any of the Baseline uropathogen(s) identified at study entry; Indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. |
| Secondary | Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the ME Population | At Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU) | Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, defined as reduction of baseline uropathogens to \<10\^3 CFU/mL on urine culture and negative repeated blood culture (if blood culture was positive at Baseline); Persistence, defined as Isolation from urine culture of ≥10\^3 CFU/mL or from blood of any of the Baseline uropathogen(s) identified at study entry; Indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. |
| Secondary | Number of Participants With Overall Response at EOT, TOC, and LFU Visits in Participants With Drug-Resistant Enterobacterales in Micro-ITT Population | Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU) | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | At Day 17 (TOC) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data reported is at the TOC timepoint only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population | At Day 17 (TOC) | The ME population includes participants who meet the definition for both the micro-ITT and clinically evaluable (CE) populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). In this outcome measure, data is reported for categories at the TOC timepoint only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response at the End-of-Treatment (EOT) and Late Follow-Up (LFU) Visits in the Micro-ITT Population | At Day 10 (EOT) and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data is reported for categories at EOT and LFU timepoints only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response at EOT and LFU Visits in the ME Population | At Day 10 (EOT) and Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and clinically evaluable (CE) populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. In this outcome measure, data is reported for categories at EOT and LFU timepoints only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the Micro-ITT Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the CE Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The CE population includes participants in the ITT Population or all randomized participants, with no major protocol deviations who received ≥8 doses of study drug (or \<8 if discontinued due to AE or death), had ≥80% treatment compliance, achieved clinical cure or failure at EOT, TOC, or LFU, had a cUTI/AP diagnosis, and did not violate prior antibiotic use criteria. Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the ME Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the Micro-ITT Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the ME Population | At Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response at EOT, TOC, and LFU Visits in Participants With Drug-Resistant Enterobacterales in Micro-ITT Population | Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group378
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | TBP-PI-HBr | Responder | 261 | Participants | |
| Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | Imipenem-cilastatin | Responder | 291 | Participants | |
| Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | TBP-PI-HBr | Non-responder | 171 | Participants | |
| Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | Imipenem-cilastatin | Non-responder | 179 | Participants | |
| Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | TBP-PI-HBr | Indeterminate | 14 | Participants | |
| Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | Imipenem-cilastatin | Indeterminate | 13 | Participants | |
| Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population | TBP-PI-HBr | Responder | 250 | Participants | |
| Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population | Imipenem-cilastatin | Responder | 282 | Participants | |
| Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population | TBP-PI-HBr | Non-responder | 160 | Participants | |
| Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population | Imipenem-cilastatin | Non-responder | 170 | Participants |
1 to 10 of 378Source ClinicalTrials.gov
See all 378 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TBP-PI-HBr | 844 | |
| Overall Study | STARTED | Imipenem-cilastatin | 846 | |
| Overall Study | ITT Population | TBP-PI-HBr | 844 | |
| Overall Study | ITT Population | Imipenem-cilastatin | 846 | |
| Overall Study | Micro-ITT Population | TBP-PI-HBr | 446 | |
| Overall Study | Micro-ITT Population | Imipenem-cilastatin | 483 | |
| Overall Study | COMPLETED | TBP-PI-HBr | 810 | |
| Overall Study | COMPLETED | Imipenem-cilastatin | 818 | |
| Overall Study | NOT COMPLETED | TBP-PI-HBr | 34 | |
| Overall Study | NOT COMPLETED | Imipenem-cilastatin | 28 |
Source ClinicalTrials.gov
Adverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | TBP-PI-HBr | 68 | 843 | |
| other | Diarrhoea | Gastrointestinal disorders | Imipenem-cilastatin | 23 | 844 | |
| serious | Cardiac failure | Cardiac disorders | TBP-PI-HBr | 0 | 843 | |
| serious | Cardiac failure | Cardiac disorders | Imipenem-cilastatin | 2 | 844 | |
| serious | Urinary tract infection | Infections and infestations | TBP-PI-HBr | 6 | 843 | |
| serious | Urinary tract infection | Infections and infestations | Imipenem-cilastatin | 3 | 844 | |
| serious | Pneumonia | Infections and infestations | TBP-PI-HBr | 0 | 843 | |
| serious | Pneumonia | Infections and infestations | Imipenem-cilastatin | 3 | 844 | |
| serious | Clostridium difficile colitis | Infections and infestations | TBP-PI-HBr | 0 | 843 | |
| serious | Clostridium difficile colitis | Infections and infestations | Imipenem-cilastatin | 2 | 844 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TBP-PI-HBr | 2 | 843 |
| Total, all-cause mortality | Imipenem-cilastatin | 2 | 844 |
| Total, other adverse events | TBP-PI-HBr | 68 | 843 |
| Total, other adverse events | Imipenem-cilastatin | 23 | 844 |
| Total, serious adverse events | TBP-PI-HBr | 29 | 843 |
| Total, serious adverse events | Imipenem-cilastatin | 22 | 844 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TBP-PI-HBr vs Imipenem-cilastatin: deaths from any cause | Trial comparisons |
| TBP-PI-HBr vs Imipenem-cilastatin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06059846
GET https://conductscience.org/api/trials/v1/NCT06059846/results?page=2