Trial · NCT02753946
Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections
NCT02753946, Phase 2, Phase 3, Completed, Nabriva Therapeutics AG; results first posted 2018-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections. Trials, record NCT02753946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02753946
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections
- NCT number
- NCT02753946
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 465 participants, actual
- Lead sponsor
- Nabriva Therapeutics AG
- Conditions
- Urinary Tract Infection Symptomatic, Acute Pyelonephritis, Urinary Tract Infection Complicated
- Interventions
- ZTI-01, Piperacillin-tazobactam
- First posted
- 2016-04-28
- Last updated
- 2019-03-07
- Other registries' IDs
- eudract:2015-003372-73
- Results first posted
- 2018-12-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With an Overall Success | TOC Visit (Day 19) | Clinical cure (resolution or significant improvement in signs and symptoms) and microbiologic eradication (baseline pathogen) in m-MITT population |
| Secondary | Number of Patients With a Response of Clinical Cure in Various Protocol Populations | TOC Visit (Day 19) | mMITT |
| Secondary | Number of Patients With a Response of Microbiologic Eradication | TOC Visit (Day 19) | mMITT |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With an Overall Success | TOC Visit (Day 19) | Microbiologic Modified Intent-to-Treat (m-MITT) population was used to assess overall success. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With a Response of Clinical Cure in Various Protocol Populations | TOC Visit (Day 19) | Microbiologic Modified Intent-to-Treat (m-MITT) population was used to assess clinical cure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With a Response of Microbiologic Eradication | TOC Visit (Day 19) | Microbiologic Modified Intent-to-Treat (m-MITT) population was used to assess microbiologic eradication. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With an Overall Success | ZTI-01 | 119 | Participants | ||
| Number of Patients With an Overall Success | Piperacillin Tazobactam | 97 | Participants | ||
| Number of Patients With a Response of Clinical Cure in Various Protocol Populations | ZTI-01 | 167 | Participants | ||
| Number of Patients With a Response of Clinical Cure in Various Protocol Populations | Piperacillin Tazobactam | 163 | Participants | ||
| Number of Patients With a Response of Microbiologic Eradication | ZTI-01 | 121 | Participants | ||
| Number of Patients With a Response of Microbiologic Eradication | Piperacillin Tazobactam | 100 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ZTI-01 | 233 | |
| Overall Study | STARTED | Piperacillin Tazobactam | 231 | |
| Overall Study | COMPLETED | ZTI-01 | 219 | |
| Overall Study | COMPLETED | Piperacillin Tazobactam | 222 | |
| Overall Study | NOT COMPLETED | ZTI-01 | 14 | |
| Overall Study | NOT COMPLETED | Piperacillin Tazobactam | 9 |
Source ClinicalTrials.gov
Adverse events36
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 | Nausea | Gastrointestinal disorders | ZTI-01 | 10 | 233 | |
| other | Nausea | Gastrointestinal disorders | Piperacillin Tazobactam | 3 | 231 | |
| other | Diarrhea | Gastrointestinal disorders | ZTI-01 | 9 | 233 | |
| other | Diarrhea | Gastrointestinal disorders | Piperacillin Tazobactam | 11 | 231 | |
| other | Vomiting | Gastrointestinal disorders | ZTI-01 | 9 | 233 | |
| other | Vomiting | Gastrointestinal disorders | Piperacillin Tazobactam | 1 | 231 | |
| other | Infusion site phlebitis | General disorders | ZTI-01 | 2 | 233 | |
| other | Infusion site phlebitis | General disorders | Piperacillin Tazobactam | 6 | 231 | |
| other | Alanine aminotransferase increased | Investigations | ZTI-01 | 20 | 233 | |
| other | Alanine aminotransferase increased | Investigations | Piperacillin Tazobactam | 6 | 231 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZTI-01 | 0 | 233 |
| Total, all-cause mortality | Piperacillin Tazobactam | 0 | 231 |
| Total, other adverse events | ZTI-01 | 55 | 233 |
| Total, other adverse events | Piperacillin Tazobactam | 31 | 231 |
| Total, serious adverse events | ZTI-01 | 5 | 233 |
| Total, serious adverse events | Piperacillin Tazobactam | 6 | 231 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30861061 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ZTI-01 vs Piperacillin Tazobactam: Number of Patients With an Overall Success | Trial comparisons |
| ZTI-01 vs Piperacillin Tazobactam: Number of Patients With a Response of Microbiologic Eradication | Trial comparisons |
| ZTI-01 vs Piperacillin Tazobactam: Number of Patients With a Response of Clinical Cure in Various Protocol Populations | Trial comparisons |
| ZTI-01 vs Piperacillin Tazobactam: deaths from any cause | Trial comparisons |
| ZTI-01 vs Piperacillin Tazobactam: 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/NCT02753946
GET https://conductscience.org/api/trials/v1/NCT02753946/events?page=2