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

Phase 3

Completed

• Conditions: Community-acquired Pneumonia; Bacterial Pneumonia
• Interventions: Drug: Moxifloxacin; Drug: Omadacycline

• Registration Number: NCT04779242
• Lead Sponsor: Paratek Pharmaceuticals Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-25
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-03
• Primary Completion: 2024-03-27
• Study Completion: 2024-03-27
• Status Verified: 2025-03
• Results First Submitted: 2025-03-20
• Results First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Results First Posted: 2025-04-09
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin	Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration
Omadacycline	Omadacycline	Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit	72 to 120 hours after the first dose of test article	Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in CABP symptoms. Response is determined programmatically using 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, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in 2CABP symptoms, worsening of CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event requiring alternative antibacterial treatment, or death

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit	5 to 10 days after the last dose of test article	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.
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	5 to 10 days after the last dose of test article	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.

Trial Locations

Locations (55)

Site 803; 🇭🇺 Debrecen, Hungary

Site 212; 🇧🇬 Vidin, Bulgaria

Site 206; 🇧🇬 Ruse, Bulgaria

Site 407; 🇬🇪 Tbilisi, Georgia

Site 901; 🇵🇱 Chrzanow, Poland

Site 210; 🇧🇬 Gabrovo, Bulgaria

Site 211; 🇧🇬 Vratsa, Bulgaria

Site 302; 🇭🇷 Split, Croatia

Site 304; 🇭🇷 Zagreb, Croatia

Site 303; 🇭🇷 Zagreb, Croatia

Site 401; 🇬🇪 Tbilisi, Georgia

Site 406; 🇬🇪 Tbilisi, Georgia

Site 608; 🇺🇦 Zaporizhia, Ukraine

Site 201; 🇧🇬 Pleven, Bulgaria

Site 402; 🇬🇪 Tbilisi, Georgia

Site 403; 🇬🇪 Tbilisi, Georgia

Site 405; 🇬🇪 Tbilisi, Georgia

Site 804; 🇭🇺 Kistarcsa, Hungary

Site 509; 🇷🇺 Saint Petersburg, Russian Federation

Site 703; 🇷🇸 Belgrade, Serbia

Site 705; 🇷🇸 Belgrade, Serbia

Site 707; 🇷🇸 Belgrade, Serbia

Site 701; 🇷🇸 Kragujevac, Serbia

Site 706; 🇷🇸 Sremska Kamenica, Serbia

Site 606; 🇺🇦 Dnipro, Ukraine

Site 604; 🇺🇦 Kharkiv, Ukraine

Site 506; 🇷🇺 Moscow, Russian Federation

Site 204; 🇧🇬 Sofia, Bulgaria

Site 404; 🇬🇪 Tbilisi, Georgia

Site 805; 🇭🇺 Torokbalint, Hungary

Site 602; 🇺🇦 Kharkiv, Ukraine

Site 607; 🇺🇦 Kyiv, Ukraine

Site 801; 🇭🇺 Budapest, Hungary

Site 208; 🇧🇬 Pernik, Bulgaria

Site 202; 🇧🇬 Sofia, Bulgaria

Site 205; 🇧🇬 Sofia, Bulgaria

Site 209; 🇧🇬 Sofia, Bulgaria

Site 904; 🇵🇱 Krakow, Poland

Site 902; 🇵🇱 Oswiecim, Poland

Site 507; 🇷🇺 Saint Petersburg, Russian Federation

Site 508; 🇷🇺 Saint Petersburg, Russian Federation

Site 704; 🇷🇸 Belgrade, Serbia

Site708; 🇷🇸 Belgrade, Serbia

Site 702; 🇷🇸 Niš, Serbia

Site 611; 🇺🇦 Kharkiv, Ukraine

Site 603; 🇺🇦 Kyiv, Ukraine

Site 605; 🇺🇦 Kyiv, Ukraine

Site 610; 🇺🇦 Zaporizhia, Ukraine

Site 510; 🇷🇺 Moscow, Russian Federation

Site 903; 🇵🇱 Leczna, Poland

Site 609; 🇺🇦 Kyiv, Ukraine

Site 213; 🇧🇬 Lom, Bulgaria

Site 207; 🇧🇬 Sliven, Bulgaria

Site 301; 🇭🇷 Zagreb, Croatia

Site 802; 🇭🇺 Balassagyarmat, Hungary