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

Paratek

Status and phase: Completed; Phase 2

Conditions: Acute Pyelonephritis

Treatments: Drug: Levofloxacin; Drug: Omadacycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03757234

PTK0796-AP-17202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 5 patient groups

Omadacycline 200 iv/200 iv

Experimental group

Description:

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.

Treatment:

Drug: Omadacycline

Drug: Omadacycline

Omadacycline 200 iv/100 iv

Experimental group

Description:

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.

Treatment:

Drug: Omadacycline

Drug: Omadacycline

Omadacycline 200 iv/300 po or 100 iv

Experimental group

Description:

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.

Treatment:

Drug: Omadacycline

Drug: Omadacycline

Omadacycline 200 iv/450 po or 100 iv

Experimental group

Description:

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.

Treatment:

Drug: Omadacycline

Drug: Omadacycline

Levofloxacin 750 iv/750 po or iv

Active Comparator group

Description:

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.

Treatment:

Drug: Levofloxacin