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

NCT ID: NCT03757234

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2019-07-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Omadacycline 200 iv/200 iv

On Day 1, participants received omadacycline 200 milligrams intravenously (iv). On Days 2 through 7, participants continued to receive omadacycline 200 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.

Group Type: EXPERIMENTAL

Omadacycline

Intervention Type: DRUG

iv solution

Omadacycline 200 iv/100 iv

On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes.

Group Type: EXPERIMENTAL

Omadacycline

Intervention Type: DRUG

iv solution

Omadacycline 200 iv/300 po or 100 iv

On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 300 milligrams per oral (po). All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.

Group Type: EXPERIMENTAL

Omadacycline

Intervention Type: DRUG

po tablets

Omadacycline

Intervention Type: DRUG

iv solution

Omadacycline 200 iv/450 po or 100 iv

On Day 1, participants received omadacycline 200 milligrams iv. On Days 2 through 7, participants received omadacycline 100 milligrams iv or omadacycline 450 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.

Group Type: EXPERIMENTAL

Omadacycline

Intervention Type: DRUG

po tablets

Omadacycline

Intervention Type: DRUG

iv solution

Levofloxacin 750 iv/750 po or iv

On Day 1, participants received levofloxacin 750 milligrams iv. On Days 2 through 7, participants received levofloxacin 750 milligrams iv or levofloxacin 750 milligrams po. All doses were administered once-per-day and iv doses were administered in 150 milliliters of normal saline as continuous infusions over 90 minutes. All oral doses were taken in a fasted state.

Group Type: ACTIVE_COMPARATOR

Levofloxacin

Intervention Type: DRUG

iv solution/po tablets

Interventions

Omadacycline

po tablets

Intervention Type: DRUG

Levofloxacin

iv solution/po tablets

Intervention Type: DRUG

Omadacycline

iv solution

Intervention Type: DRUG

Other Intervention Names

Nuzyra; Levaquin; Nuzyra

Eligibility Criteria

Inclusion Criteria

• Female participants, age 18-65 years who have signed the informed consent form
• Must have a qualifying acute pyelonephritis
• Participants must not be pregnant at the time of enrollment
• Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
• Must be able to comply with all of the requirements of the study

Exclusion Criteria

• Males
• Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
• Infections that require antibacterial treatment for greater than 14 days
• Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
• Evidence of significant immunological disease
• Evidence of liver impairment or disease
• Evidence of unstable cardiac disease
• Severe renal disease or requirement for dialysis
• Evidence of septic shock
• Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
• Has received an investigational drug within the past 30 days
• Participants who are pregnant or nursing
• Unable or unwilling to comply with the protocol requirements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Paratek Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 201

Tbilisi, , Georgia

Site 202

Tbilisi, , Georgia

Site 203

Tbilisi, , Georgia

Site 204

Tbilisi, , Georgia

Site 301

Daugavpils, , Latvia

Site 304

Liepāja, , Latvia

Site 305

Rēzekne, , Latvia

Site 302

Riga, , Latvia

Site 303

Valmiera, , Latvia

Site 409

Krasnoyarsk, , Russia

Site 408

Moscow, , Russia

Site 410

Moscow, , Russia

Site 415

Penza, , Russia

Site 407

Rostov-on-Don, , Russia

Site 405

Rostov-on-Don, , Russia

Site 411

Saint Petersburg, , Russia

Site 406

Saint Petersburg, , Russia

Site 402

Saint Petersburg, , Russia

Site 412

Saint Petersburg, , Russia

Site 403

Saint Petersburg, , Russia

Site 414

Saint Petersburg, , Russia

Site 401

Saint Petersburg, , Russia

Site 404

Saint Petersburg, , Russia

Site 413

Smolensk, , Russia

Site 502

Chernivtsi, , Ukraine

Site 506

Dnipro, , Ukraine

Site 505

Kharkiv, , Ukraine

Site 504

Kyiv, , Ukraine

Site 503

Kyiv, , Ukraine

Site 501

Lviv, , Ukraine

Site 507

Zaporizhzhia, , Ukraine

Countries

Georgia; Latvia; Russia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PTK0796-AP-17202

Identifier Type: -

Identifier Source: org_study_id