Clinical trial NCT03757234: IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pyelonephritis
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
timeFrame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
measure: Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
timeFrame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
measure: Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
timeFrame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
measure: Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population)
timeFrame: Day 21 (A PTE occurred on Day 21 ± 2 days after the participant's first dose of study drug).
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
timeFrame: up to approximately 28 days
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Site 201
city: Tbilisi
country: Georgia
facility: Site 202
city: Tbilisi
country: Georgia
facility: Site 203
city: Tbilisi
country: Georgia
facility: Site 204
city: Daugavpils
country: Latvia
facility: Site 301
city: Liepāja
country: Latvia
facility: Site 304
city: Riga
country: Latvia
facility: Site 302
city: Rēzekne
country: Latvia
facility: Site 305
city: Valmiera
country: Latvia
facility: Site 303
city: Krasnoyarsk
country: Russian Federation
facility: Site 409
city: Moscow
country: Russian Federation
facility: Site 408
city: Moscow
country: Russian Federation
facility: Site 410
city: Penza
country: Russian Federation
facility: Site 415
city: Rostov-on-Don
country: Russian Federation
facility: Site 407
city: Rostov-on-Don
country: Russian Federation
facility: Site 405
city: Saint Petersburg
country: Russian Federation
facility: Site 411
city: Saint Petersburg
country: Russian Federation
facility: Site 406
city: Saint Petersburg
country: Russian Federation
facility: Site 402
city: Saint Petersburg
country: Russian Federation
facility: Site 412
city: Saint Petersburg
country: Russian Federation
facility: Site 403
city: Saint Petersburg
country: Russian Federation
facility: Site 414
city: Saint Petersburg
country: Russian Federation
facility: Site 401
city: Saint Petersburg
country: Russian Federation
facility: Site 404
city: Smolensk
country: Russian Federation
facility: Site 413
city: Chernivtsi
country: Ukraine
facility: Site 502
city: Dnipro
country: Ukraine
facility: Site 506
city: Kharkiv
country: Ukraine
facility: Site 505
city: Kyiv
country: Ukraine
facility: Site 504
city: Kyiv
country: Ukraine
facility: Site 503
city: Lviv
country: Ukraine
facility: Site 501
city: Zaporizhzhia
country: Ukraine
facility: Site 507
Study officials:
References: