COMPLETED

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)

Conditions

Urinary Tract Infection Acute Pyelonephritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (≥18 years of age) with cUTI or AP.

Official Title

A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Quick Facts

Study Start:2023-12-21

Study Completion:2025-02-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06059846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Have a diagnosis of cUTI or AP. 2. Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following: 1. at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment 2. at least 10 WBCs per millimeters cubed (mm\^3) in unspun urine 3. positive leukocyte esterase (LE) on urinalysis Note: Participants may be randomized and administered study drug prior to knowledge of urine culture results, but pyuria must be documented. 3. Expectation, in the judgment of the Investigator, that the participant will survive with effective antimicrobial therapy and appropriate supportive care for the anticipated duration of the study.	1. Presence of any known or suspected disease or condition that may confound the assessment of efficacy. 2. Gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation. 3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period. 4. Creatinine clearance (CrCl) of ≤30 milliliters per minute (mL/min), as estimated by the Cockcroft-Gault formula. 5. Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI/AP. 6. Receipt of a potentially effective antimicrobial within 72 hours prior to study randomization. 7. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5×upper limit of normal (ULN) or total bilirubin \>3×ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy). 8. Pregnant or lactating women. 9. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures). 10. History of proven or suspected Clostridioides difficile associated diarrhea. 11. History of human immunodeficiency virus (HIV) infection. 12. QT interval corrected using Fridericia's formula (QTcF) \>480 milliseconds (msec) based on screening ECG. 13. History of known genetic metabolism anomaly associated with carnitine deficiency. 14. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.

Inclusion Criteria

Exclusion Criteria

1. Have a diagnosis of cUTI or AP.
2. Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following:
1. at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment
2. at least 10 WBCs per millimeters cubed (mm\^3) in unspun urine
3. positive leukocyte esterase (LE) on urinalysis Note: Participants may be randomized and administered study drug prior to knowledge of urine culture results, but pyuria must be documented.
3. Expectation, in the judgment of the Investigator, that the participant will survive with effective antimicrobial therapy and appropriate supportive care for the anticipated duration of the study.

1. Presence of any known or suspected disease or condition that may confound the assessment of efficacy.
2. Gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation.
3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.
4. Creatinine clearance (CrCl) of ≤30 milliliters per minute (mL/min), as estimated by the Cockcroft-Gault formula.
5. Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI/AP.
6. Receipt of a potentially effective antimicrobial within 72 hours prior to study randomization.
7. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5×upper limit of normal (ULN) or total bilirubin \>3×ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).
8. Pregnant or lactating women.
9. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
10. History of proven or suspected Clostridioides difficile associated diarrhea.
11. History of human immunodeficiency virus (HIV) infection.
12. QT interval corrected using Fridericia's formula (QTcF) \>480 milliseconds (msec) based on screening ECG.
13. History of known genetic metabolism anomaly associated with carnitine deficiency.
14. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.

Contacts and Locations

Principal Investigator

David Hong, MD

STUDY_DIRECTOR

Spero Therapeutics

Study Locations (Sites)

Medical facility

Miami, Florida, 33144

United States

Medical Facility

Miami, Florida, 33176

United States

Collaborators and Investigators

Sponsor: Spero Therapeutics

David Hong, MD, STUDY_DIRECTOR, Spero Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21

Study Completion Date2025-02-06

Study Record Updates

Study Start Date2023-12-21

Study Completion Date2025-02-06

Terms related to this study

Additional Relevant MeSH Terms

Urinary Tract Infection
Acute Pyelonephritis