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Clinical trial

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)

NCT06059846 is registered in ClinicalTrials.gov with Spero Therapeutics as lead sponsor.

NCT NCT06059846
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Registry record

As filed in ClinicalTrials.gov.

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)
Lead sponsor
Spero Therapeutics
Phase
Phase 3
Overall status
Completed
Start date
December 21, 2023
Completion date
February 6, 2025
Enrollment
1,690 (actual)
Sites
85

Conditions

As the registry lists them; a condition with its own page is linked.

acute pyelonephritis, urinary tract infection