NCT03757234

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of iv or iv/po Omadacycline and iv/po Levofloxacin in the Treatment of Adults With Acute Pyelonephritis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Paratek Pharmaceuticals Inc · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis.

Detailed description

This was a randomized (1:1:1:1:1), double-blind, double-dummy, adaptive designed, Phase 2 study. Based on review of the efficacy and microbiology data, the DMC modified the randomization algorithm, and no further participants were enrolled in the following treatment arms after May 2019: the omadacycline 200 iv/100 iv, omadacycline 200 iv/300 po or 100 iv, and omadacycline 200 iv/450 po or 100 iv arms. After this change, participants were randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.

Conditions

• Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	Omadacycline	po tablets
DRUG	Levofloxacin	iv solution/po tablets
DRUG	Omadacycline	iv solution

Timeline

• Start date: 2018-11-19
• Primary completion: 2019-06-26
• Completion: 2019-07-24
• First posted: 2018-11-28
• Last updated: 2020-07-07
• Results posted: 2020-07-07

Locations

31 sites across 4 countries: Georgia, Latvia, Russia, Ukraine

Regulatory

• FDA-regulated drug study