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Clinical trial

A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

NCT03788967 is registered in ClinicalTrials.gov with Spero Therapeutics as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Lead sponsor
Spero Therapeutics
Phase
Phase 3
Overall status
Completed
Start date
June 3, 2019
Completion date
May 27, 2020
Enrollment
1,372 (actual)
Sites
96

Conditions

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

acute pyelonephritis, complicated urinary tract infection