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

Community-acquired Pneumonia Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04779242
• Other study ID #: PTK0796-CABP-19302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 25, 2021
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: Paratek Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 670
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Community-acquired Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Omadacycline
IV for injection, oral tablets
• Moxifloxacin
IV solution, oral tablets

Locations

Country	Name	City	State
Bulgaria	Site 210	Gabrovo
Bulgaria	Site 213	Lom
Bulgaria	Site 208	Pernik
Bulgaria	Site 201	Pleven
Bulgaria	Site 206	Ruse
Bulgaria	Site 207	Sliven
Bulgaria	Site 202	Sofia
Bulgaria	Site 204	Sofia
Bulgaria	Site 205	Sofia
Bulgaria	Site 209	Sofia
Bulgaria	Site 212	Vidin
Bulgaria	Site 211	Vratsa
Croatia	Site 302	Split
Croatia	Site 301	Zagreb
Croatia	Site 303	Zagreb
Croatia	Site 304	Zagreb
Georgia	Site 401	Tbilisi
Georgia	Site 402	Tbilisi
Georgia	Site 403	Tbilisi
Georgia	Site 404	Tbilisi
Georgia	Site 405	Tbilisi
Georgia	Site 406	Tbilisi
Georgia	Site 407	Tbilisi
Hungary	Site 802	Balassagyarmat
Hungary	Site 801	Budapest
Hungary	Site 803	Debrecen
Hungary	Site 804	Kistarcsa
Hungary	Site 805	Torokbalint
Poland	Site 901	Chrzanow
Poland	Site 904	Krakow
Poland	Site 903	Leczna
Poland	Site 902	Oswiecim
Russian Federation	Site 506	Moscow
Russian Federation	Site 510	Moscow
Russian Federation	Site 507	Saint Petersburg
Russian Federation	Site 508	Saint Petersburg
Russian Federation	Site 509	Saint Petersburg
Serbia	Site 703	Belgrade
Serbia	Site 704	Belgrade
Serbia	Site 705	Belgrade
Serbia	Site 707	Belgrade
Serbia	Site708	Belgrade
Serbia	Site 701	Kragujevac
Serbia	Site 702	Niš
Serbia	Site 706	Sremska Kamenica
Ukraine	Site 606	Dnipro
Ukraine	Site 602	Kharkiv
Ukraine	Site 604	Kharkiv
Ukraine	Site 611	Kharkiv
Ukraine	Site 603	Kyiv
Ukraine	Site 605	Kyiv
Ukraine	Site 607	Kyiv
Ukraine	Site 609	Kyiv
Ukraine	Site 608	Zaporizhia
Ukraine	Site 610	Zaporizhia

Sponsors (1)

Lead Sponsor	Collaborator
Paratek Pharmaceuticals Inc

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Georgia,  Hungary,  Poland,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	72 to 120 hours after the first dose of test article
Secondary	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.	5 to 10 days after the last dose of test article
Secondary	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.	5 to 10 days after the last dose of test article