Trial · NCT05204368
Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)
NCT05204368, Phase 3, Unknown, Evopoint Biosciences Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40). Trials, record NCT05204368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05204368
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)
- NCT number
- NCT05204368
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 780 participants, estimated
- Lead sponsor
- Evopoint Biosciences Inc.
- Conditions
- Complicated Urinary Tract Infection Including Acute Pyelonephritis
- Interventions
- Combination of Imipenem/Cilastatin and XNW4107, Meropenem
- First posted
- 2022-01-24
- Last updated
- 2023-02-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | overall success | Day 21[±2 days] | The proportion of patients who achieve overall success at the Test of cure(TOC) visit in the micro-modified-intent-to-treat(micro-MITT) population. Overall success requires symptomatic clinical success and microbiologic success at the TOC visit. |
| Secondary | overall success | EOT: from treatment day 7 up to day 15 | The proportion of patients who achieve overall success at the End of treatment (EOT) visit in the micro-MITT population. |
| Secondary | overall success | Day 28[±3 days] | The proportion of patients who achieve overall success at the Late follow-up(LFU) visit in the micro-MITT, extended micro-MITT, Clinically evaluable(CE), Microbiologically evaluable(ME) populations. |
| Secondary | symptomatic clinical success | Day 4; EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days] | The proportion of patients with symptomatic clinical success at Day 4, EOT, TOC, and LFU visit in the micro-MITT, extended micro-MITT, CE, and ME populations |
| Secondary | microbiological success | EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days] | The proportion of patients with microbiological success at EOT, TOC, and LFU visit in the micro-MITT, extended micro-MITT, and ME populations |
| Secondary | By-pathogen microbiological success | EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days] | The proportion of patients with by-pathogen microbiological success at EOT, TOC, and LFU visit in the micro-MITT, extended micro-MITT, and ME populations |
| Secondary | The proportion of overall success; symptomatic clinical, and microbiologic success | EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days] | The proportion of overall success; symptomatic clinical, and microbiologic success at EOT, TOC, and LFU visit in the Carbapenem-resistant-MITT(CR-MITT) population |
| Secondary | clinical success | Day 21[±2 days] | The proportion of patients with clinical success based on the investigator's assessment of clinical response at TOC visit in the micro-MITT population |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05204368
GET https://conductscience.org/api/trials/v1/NCT05204368/registered