Status:
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)
Lead Sponsor:
Spero Therapeutics
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Urinary Tract Infection
Acute Pyelonephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 diarrhea.
- 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.
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2025
Estimated Enrollment :
1690 Patients enrolled
Trial Details
Trial ID
NCT06059846
Start Date
December 21 2023
End Date
February 6 2025
Last Update
November 25 2025
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33176
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Buenos Aires, Argentina
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Córdoba, Argentina