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Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

Primary Purpose

Community-acquired Pneumonia, Bacterial Pneumonia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Omadacycline
Moxifloxacin
Sponsored by
Paratek Pharmaceuticals Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 210Recruiting
  • Site 213Recruiting
  • Site 208Recruiting
  • Site 201Recruiting
  • Site 206
  • Site 207Recruiting
  • Site 202
  • Site 204Recruiting
  • Site 205
  • Site 209Recruiting
  • Site 212Recruiting
  • Site 211Recruiting
  • Site 302Recruiting
  • Site 301Recruiting
  • Site 303Recruiting
  • Site 304
  • Site 401
  • Site 402Recruiting
  • Site 403Recruiting
  • Site 404Recruiting
  • Site 405Recruiting
  • Site 406Recruiting
  • Site 407
  • Site 802
  • Site 801Recruiting
  • Site 803Recruiting
  • Site 804
  • Site 805Recruiting
  • Site 901Recruiting
  • Site 904Recruiting
  • Site 903Recruiting
  • Site 902Recruiting
  • Site 506
  • Site 510
  • Site 507
  • Site 508
  • Site 509
  • Site 703Recruiting
  • Site 704Recruiting
  • Site 705
  • Site 707Recruiting
  • Site708Recruiting
  • Site 701Recruiting
  • Site 702Recruiting
  • Site 706Recruiting
  • Site 606
  • Site 602
  • Site 604
  • Site 611
  • Site 603
  • Site 605
  • Site 607
  • Site 609
  • Site 608
  • Site 610

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Omadacycline

Moxifloxacin

Arm Description

Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.

Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration

Outcomes

Primary Outcome Measures

Number of participants with early clinical response in the Intent-to-Treat (ITT) Population at the Early Clinical Response (ECR) visit
Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response is determined programmatically using the investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in CABP symptoms, worsening of any CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event, or death.

Secondary Outcome Measures

Number of participants with the indicated investigator assessment of clinical response in the Intent-to-Treat (ITT) Population at the Post Therapy Evaluation (PTE) Visit
At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.
Number of participants with the indicated investigator assessment of clinical response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the Post-Therapy Evaluation (PTE) Visit
At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.

Full Information

First Posted
February 26, 2021
Last Updated
October 2, 2023
Sponsor
Paratek Pharmaceuticals Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04779242
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paratek Pharmaceuticals Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Bacterial Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
670 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omadacycline
Arm Type
Experimental
Arm Description
Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration
Intervention Type
Drug
Intervention Name(s)
Omadacycline
Other Intervention Name(s)
NUZYRA
Intervention Description
IV for injection, oral tablets
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Avelox
Intervention Description
IV solution, oral tablets
Primary Outcome Measure Information:
Title
Number of participants with early clinical response in the Intent-to-Treat (ITT) Population at the Early Clinical Response (ECR) visit
Description
Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response is determined programmatically using the investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in CABP symptoms, worsening of any CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event, or death.
Time Frame
72 to 120 hours after the first dose of test article
Secondary Outcome Measure Information:
Title
Number of participants with the indicated investigator assessment of clinical response in the Intent-to-Treat (ITT) Population at the Post Therapy Evaluation (PTE) Visit
Description
At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.
Time Frame
5 to 10 days after the last dose of test article
Title
Number of participants with the indicated investigator assessment of clinical response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the Post-Therapy Evaluation (PTE) Visit
Description
At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.
Time Frame
5 to 10 days after the last dose of test article

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Kirsch
Phone
484 751 4925
Email
courtney.kirsch@paratekpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Manley
Email
amy.manley@paratekpharma.com
Facility Information:
Facility Name
Site 210
City
Gabrovo
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donchev
Facility Name
Site 213
City
Lom
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivanov
Facility Name
Site 208
City
Pernik
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petrova
Facility Name
Site 201
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdanova
Facility Name
Site 206
City
Ruse
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Site 207
City
Sliven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petkov
Facility Name
Site 202
City
Sofia
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Site 204
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirkova
Facility Name
Site 205
City
Sofia
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Site 209
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Slaveva Mladenova
Facility Name
Site 212
City
Vidin
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naydenova
Facility Name
Site 211
City
Vratsa
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haytova
Facility Name
Site 302
City
Split
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lozo Vukovac
Facility Name
Site 301
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ljubicic
Facility Name
Site 303
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Puljiz
Facility Name
Site 304
City
Zagreb
Country
Croatia
Individual Site Status
Completed
Facility Name
Site 401
City
Tbilisi
Country
Georgia
Individual Site Status
Completed
Facility Name
Site 402
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsarava
Facility Name
Site 403
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiknadze
Facility Name
Site 404
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindiashvili
Facility Name
Site 405
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shonia
Facility Name
Site 406
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zubadalashvili
Facility Name
Site 407
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sulaqvelidze
Facility Name
Site 802
City
Balassagyarmat
Country
Hungary
Individual Site Status
Terminated
Facility Name
Site 801
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Csoma
Facility Name
Site 803
City
Debrecen
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kardos
Facility Name
Site 804
City
Kistarcsa
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirschner
Facility Name
Site 805
City
Torokbalint
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Putz
Facility Name
Site 901
City
Chrzanow
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harat
Facility Name
Site 904
City
Krakow
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Straszak
Facility Name
Site 903
City
Leczna
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Skorski
Facility Name
Site 902
City
Oswiecim
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kobielusz-Gembala
Facility Name
Site 506
City
Moscow
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Site 510
City
Moscow
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Site 507
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Site 508
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Site 509
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Site 703
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stjepanovic
Facility Name
Site 704
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stojanovic
Facility Name
Site 705
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stojsavljevic
Facility Name
Site 707
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djuric
Facility Name
Site708
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazovic Popovic
Facility Name
Site 701
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cupurdija
Facility Name
Site 702
City
Niš
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pejcic
Facility Name
Site 706
City
Sremska Kamenica
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djuric
Facility Name
Site 606
City
Dnipro
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 602
City
Kharkiv
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 604
City
Kharkiv
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Site 611
City
Kharkiv
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 603
City
Kyiv
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 605
City
Kyiv
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 607
City
Kyiv
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 609
City
Kyiv
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 608
City
Zaporizhia
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Site 610
City
Zaporizhia
Country
Ukraine
Individual Site Status
Suspended

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

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