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

• Status: Completed
• Trial end date: 2019-07-24
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paratek Pharmaceuticals Inc
• Treatments: Levofloxacin; Ofloxacin

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