Trial · NCT03788967
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, Phase 3, Completed, Spero Therapeutics; results first posted 2022-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT03788967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03788967
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT03788967
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,372 participants, actual
- Lead sponsor
- Spero Therapeutics
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis
- Interventions
- TBPM-PI-HBr, Ertapenem, Dummy Infusion, Dummy tablets
- First posted
- 2018-12-28
- Last updated
- 2022-07-25
- Other registries' IDs
- eudract:2018-003671-35
- Results first posted
- 2022-07-25
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | Day 19 (TOC) | Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days) | An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product. |
| Secondary | Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | Day 19 (TOC) | Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or acute pyelonephritis (AP) that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Secondary | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | Days 15 (EOT), Day 19 (TOC) and Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
| Secondary | Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations | Day 15 (EOT) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Clinical Cure at TOC in the CE-TOC Populations | Day 19 (TOC) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Sustained Clinical Cure at LFU in the CE-LFU Populations | Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as number of participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
| Secondary | Clinical Cure at EOT in the ME-EOT Populations | Day 15 (EOT) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Clinical Cure at TOC Days in the ME-TOC Populations | Day 19 (TOC) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Sustained Clinical Cure at LFU in the ME-LFU Population | Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | Day 19 (TOC) | Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days) | Safety analysis population included all randomized participants who received any amount of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | Day 19 (TOC) | Microbiologically evaluable (ME) - TOC is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the evaluability review plan (ERP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | Days 15 (EOT), Day 19 (TOC) and Day 25 (LFU) | Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations | Day 15 (EOT) | CE-EOT population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at EOT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure at TOC in the CE-TOC Populations | Day 19 (TOC) | CE-TOC population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at TOC. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sustained Clinical Cure at LFU in the CE-LFU Populations | Day 25 (LFU) | CE-LFU population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at LFU. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure at EOT in the ME-EOT Populations | Day 15 (EOT) | ME-EOT population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Cure at TOC Days in the ME-TOC Populations | Day 19 (TOC) | ME-TOC population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sustained Clinical Cure at LFU in the ME-LFU Population | Day 25 (LFU) | ME-LFU population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group351
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | TBPM-PI-HBr 600 mg | 264 | Participants | ||
| Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | Ertapenem 1 g | 258 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | TBPM-PI-HBr 600 mg | 176 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | Ertapenem 1 g | 176 | Participants | ||
| Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | TBPM-PI-HBr 600 mg | 254 | Participants | ||
| Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | Ertapenem 1 g | 247 | Participants | ||
| Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | TBPM-PI-HBr 600 mg | EOT | 446 | Participants | |
| Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | Ertapenem 1 g | EOT | 410 | Participants | |
| Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | TBPM-PI-HBr 600 mg | TOC | 418 | Participants | |
| Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | Ertapenem 1 g | TOC | 392 | Participants |
1 to 10 of 351Source ClinicalTrials.gov
See all 351 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TBPM-PI-HBr 600 mg | 685 | |
| Overall Study | STARTED | Ertapenem 1 g | 687 | |
| Overall Study | Micro-Intent-to-Treat (ITT) Population | TBPM-PI-HBr 600 mg | 449 | |
| Overall Study | Micro-Intent-to-Treat (ITT) Population | Ertapenem 1 g | 419 | |
| Overall Study | COMPLETED | TBPM-PI-HBr 600 mg | 653 | |
| Overall Study | COMPLETED | Ertapenem 1 g | 663 | |
| Overall Study | NOT COMPLETED | TBPM-PI-HBr 600 mg | 32 | |
| Overall Study | NOT COMPLETED | Ertapenem 1 g | 24 |
Source ClinicalTrials.gov
Adverse events48
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 | TBPM-PI-HBr 600 mg | 39 | 685 | |
| other | Diarrhoea | Gastrointestinal disorders | Ertapenem 1 g | 30 | 687 | |
| serious | Myocardial ischaemia | Cardiac disorders | TBPM-PI-HBr 600 mg | 1 | 685 | |
| serious | Myocardial ischaemia | Cardiac disorders | Ertapenem 1 g | 0 | 687 | |
| serious | Duodenal ulcer hemorrhage | Gastrointestinal disorders | TBPM-PI-HBr 600 mg | 0 | 685 | |
| serious | Duodenal ulcer hemorrhage | Gastrointestinal disorders | Ertapenem 1 g | 1 | 687 | |
| serious | Pyrexia | General disorders | TBPM-PI-HBr 600 mg | 1 | 685 | |
| serious | Pyrexia | General disorders | Ertapenem 1 g | 1 | 687 | |
| serious | Cyst | General disorders | TBPM-PI-HBr 600 mg | 0 | 685 | |
| serious | Cyst | General disorders | Ertapenem 1 g | 1 | 687 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TBPM-PI-HBr 600 mg | 0 | 685 |
| Total, all-cause mortality | Ertapenem 1 g | 0 | 687 |
| Total, other adverse events | TBPM-PI-HBr 600 mg | 39 | 685 |
| Total, other adverse events | Ertapenem 1 g | 30 | 687 |
| Total, serious adverse events | TBPM-PI-HBr 600 mg | 14 | 685 |
| Total, serious adverse events | Ertapenem 1 g | 12 | 687 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35388666 | DERIVED |
Source PubMed
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 comparisons14
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: Clinical Cure at TOC Days in the ME-TOC Populations | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: Clinical Cure at EOT in the ME-EOT Populations | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: By-Patient Microbiological Eradication at EOT in the ME-EOT Populations | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: Clinical Cure at TOC in the CE-TOC Populations | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: By-Patient Microbiological Eradication at TOC in the ME-TOC Population | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: Sustained Clinical Cure at LFU in the CE-LFU Populations | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations | Trial comparisons |
| TBPM-PI-HBr 600 mg vs Ertapenem 1 g: Sustained Clinical Cure at LFU in the ME-LFU Population | Trial comparisons |
1 to 10 of 14
See all 14 trial comparisonsTests0
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/NCT03788967
GET https://conductscience.org/api/trials/v1/NCT03788967/registered?page=2