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

Paratek Pharma, LLC, a wholly-owned subsidiary of Paratek Pharmaceuticals, Inc.0 sites200 target enrollmentJune 12, 2018

ConditionsAcute Pyelonephritis MedDRA version: 20.1Level: LLTClassification code 10001032Term: Acute pyelonephritisSystem Organ Class: 100000004862 Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

DrugsLevofloxacin Kabi Levoxa Levofloxacin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Pyelonephritis
Sponsor: Paratek Pharma, LLC, a wholly-owned subsidiary of Paratek Pharmaceuticals, Inc.
Enrollment: 200
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 12, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Paratek Pharma, LLC, a wholly-owned subsidiary of Paratek Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•1\.Written and signed informed consent must be obtained before any assessment is performed.
•2\.a. Females age 18\-65 years.
•b. Females age 18 years or older.
•Inclusion 2a will be followed for first 100 subjects enrolled. Following an interim analysis, see adaptive design section for additional information, inclusion 2b may be allowed. An administrative memo will be issued to sites to formally notify them if/when Inclusion 2b will be followed. No subjects \>65 years may be enrolled until an administrative memo is received and acknowledged by the investigator.
•3\. Clinical signs and symptoms of acute uncomplicated pyelonephritis with onset or worsening within 96 hours prior to randomization. Clinical signs and symptoms are defined as:
•Flank pain or costovertebral angle tenderness on physical examination plus at least one of the following:
•\- Chills or rigors or warmth associated with fever (oral, tympanic, rectal or core temperature \> 38°C \[\> 100\.4°F], which must be observed and documented by a health care provider), or
•\- Nausea or Vomiting
•4\. A clean\-catch midstream urine sample with dipstick analysis positive (at least \+\+) for leukocyte esterase or pyuria (white blood cell \[WBC] count \> 10/µL in unspun urine or \= 10 per high power field in spun urine sediment).
•5\. Female subjects must have a negative pregnancy test at Screening, and agree to comply with using an acceptable form of birth control (eg, abstinence, oral contraceptive, intrauterine device \[IUD], barrier contraception \[condom], tubal ligation, hysterectomy, bilateral oophorectomy, postmenopausal or vasectomized partner) from Screening through PTE.

Exclusion Criteria

•1\. Pregnant or nursing (breastfeeding) women.
•2\. Receipt of any dose of a potentially therapeutic antibacterial agent from 72 hours prior to randomization until the first dose of test article.
•3\. Anticipated need for systemic antibacterial therapy other than test article during the study period.
•4\. Infection at baseline that in the Investigator’s judgment would require more than 10 days of antibacterial therapy.
•5\. Symptoms of AP present longer than 7 days prior to randomization.
•6\. Confirmed or suspected AP caused by a pathogen that is resistant to tetracyclines or fluoroquinolones, including infection caused by fungi or mycobacteria.
•7\. Known or suspected rapidly\-progressing or life\-threatening illness including septic shock. Septic shock can be identified using the clinical criteria of hypotension requiring vasopressor therapy to maintain mean arterial blood pressure of 65mmHg or greater and having a serum lactate level greater than 2 mmol/L after adequate fluid resuscitation.
•8\. Use of an indwelling urinary catheter, nephrostomy tubes or other indwelling urinary tract device within the 30 days prior to randomization.
•9\. Confirmed or suspected urinary retention from any cause, including neurogenic bladder or obstruction.
•10\. History of surgically modified or abnormal urinary tract anatomy (eg, bladder diverticula or redundant urine collection system).