Clinical trial NCT04779242: Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia
Official title: A Phase 3b Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community-acquired Pneumonia
Bacterial Pneumonia
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, age 18 or older who have signed the informed consent form
* Must have a qualifying community-acquired bacterial pneumonia
* Subjects must not be pregnant or nursing 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

Exclusion Criteria:

* Known or suspected hospital-acquired pneumonia
* Confirmed or suspected SARS-CoV-2 infection
* Evidence of significant immunological disease
* Has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment
* Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
* Has received an investigational drug within the past 30 days

Primary outcomes:
measure: Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit
timeFrame: 72 to 120 hours after the first dose of test article
Secondary outcomes:
measure: Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit
timeFrame: 5 to 10 days after the last dose of test article
measure: Percentage of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the PTE Visit
timeFrame: 5 to 10 days after the last dose of test article
Other outcomes:
Locations:
city: Gabrovo
country: Bulgaria
facility: Site 210
city: Lom
country: Bulgaria
facility: Site 213
city: Pernik
country: Bulgaria
facility: Site 208
city: Pleven
country: Bulgaria
facility: Site 201
city: Ruse
country: Bulgaria
facility: Site 206
city: Sliven
country: Bulgaria
facility: Site 207
city: Sofia
country: Bulgaria
facility: Site 202
city: Sofia
country: Bulgaria
facility: Site 204
city: Sofia
country: Bulgaria
facility: Site 205
city: Sofia
country: Bulgaria
facility: Site 209
city: Vidin
country: Bulgaria
facility: Site 212
city: Vratsa
country: Bulgaria
facility: Site 211
city: Split
country: Croatia
facility: Site 302
city: Zagreb
country: Croatia
facility: Site 301
city: Zagreb
country: Croatia
facility: Site 303
city: Zagreb
country: Croatia
facility: Site 304
city: Tbilisi
country: Georgia
facility: Site 401
city: Tbilisi
country: Georgia
facility: Site 402
city: Tbilisi
country: Georgia
facility: Site 403
city: Tbilisi
country: Georgia
facility: Site 404
city: Tbilisi
country: Georgia
facility: Site 405
city: Tbilisi
country: Georgia
facility: Site 406
city: Tbilisi
country: Georgia
facility: Site 407
city: Balassagyarmat
country: Hungary
facility: Site 802
city: Budapest
country: Hungary
facility: Site 801
city: Debrecen
country: Hungary
facility: Site 803
city: Kistarcsa
country: Hungary
facility: Site 804
city: Torokbalint
country: Hungary
facility: Site 805
city: Chrzanow
country: Poland
facility: Site 901
city: Krakow
country: Poland
facility: Site 904
city: Leczna
country: Poland
facility: Site 903
city: Oswiecim
country: Poland
facility: Site 902
city: Moscow
country: Russian Federation
facility: Site 506
city: Moscow
country: Russian Federation
facility: Site 510
city: Saint Petersburg
country: Russian Federation
facility: Site 507
city: Saint Petersburg
country: Russian Federation
facility: Site 508
city: Saint Petersburg
country: Russian Federation
facility: Site 509
city: Belgrade
country: Serbia
facility: Site 703
city: Belgrade
country: Serbia
facility: Site 704
city: Belgrade
country: Serbia
facility: Site 705
city: Belgrade
country: Serbia
facility: Site 707
city: Belgrade
country: Serbia
facility: Site708
city: Kragujevac
country: Serbia
facility: Site 701
city: Niš
country: Serbia
facility: Site 702
city: Sremska Kamenica
country: Serbia
facility: Site 706
city: Dnipro
country: Ukraine
facility: Site 606
city: Kharkiv
country: Ukraine
facility: Site 602
city: Kharkiv
country: Ukraine
facility: Site 604
city: Kharkiv
country: Ukraine
facility: Site 611
city: Kyiv
country: Ukraine
facility: Site 603
city: Kyiv
country: Ukraine
facility: Site 605
city: Kyiv
country: Ukraine
facility: Site 607
city: Kyiv
country: Ukraine
facility: Site 609
city: Zaporizhia
country: Ukraine
facility: Site 608
city: Zaporizhia
country: Ukraine
facility: Site 610
Study officials:
affiliation: Paratek Pharmaceuticals Inc
name: Amy Manley
role: STUDY_DIRECTOR
References: