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)

Completed · Phase 3

Conditions studied: Urinary Tract Infection, Acute Pyelonephritis

In brief

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 (greater than or equal to (≥)18 years of age) with cUTI or AP.

Key facts

Study ID

NCT06059846

Run by

Spero Therapeutics

People needed

1690

Starts

2023-12-21

Expected to finish

2025-02-06

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of cUTI or AP.
• 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:
• at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment
• at least 10 WBCs per millimeters cubed (mm\^3) in unspun urine
• 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.
• 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.

You may not qualify if…

• Presence of any known or suspected disease or condition that may confound the assessment of efficacy.
• Gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation.
• Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.
• Creatinine clearance (CrCl) of ≤30 milliliters per minute (mL/min), as estimated by the Cockcroft-Gault formula.
• Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI/AP.
• Receipt of a potentially effective antimicrobial within 72 hours prior to study randomization.
• 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).
• Pregnant or lactating women.
• History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
• History of proven or suspected Clostridioides difficile associated diarrhoea.
• History of human immunodeficiency virus (HIV) infection.
• QT interval corrected using Fridericia's formula (QTcF) >480 milliseconds (msec) based on screening ECG.
• History of known genetic metabolism anomaly associated with carnitine deficiency.
• Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.
• Note: Other inclusion and exclusion criteria as per protocol may apply.

Where it is running

• Medical Facility — Kohtla-Järve, Estonia
• Medical Facility — Pärnu, Estonia
• Medical Facility — Tallinn, Estonia
• Medical Facility — Tartu, Estonia
• Medical Facility — Võru, Estonia
• Medical facility — Tbilisi, Georgia
• Medical Facility — Alexandroupoli, Greece
• Medical Facility — Athens, Greece
• Medical Facility — Ioannina, Greece
• Medical Facility — Pátrai, Greece
• Medical Facility — Thessaloniki, Greece
• Medical Facility — Budapest, Hungary
• Medical Facility — Eger, Hungary
• Medical Facility — Kistarcsa, Hungary
• Medical Facility — Nyíregyháza, Hungary
• Medical Facility — Belagavi, Karnataka, India
• Medical Facility — Bangalore, India
• Medical Facility — Jaipur, India
• Medical Facility — Lucknow, India
• Medical Facility — Varanasi, India
• Medical Facility — Daugavpils, Latvia
• Medical Facility — Liepāja, Latvia
• Medical Facility — Riga, Latvia
• Medical Facility — Valmiera, Latvia
• Medical Facility — Zagreb, Croatia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.