Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

Phase 3

Completed

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

• Registration Number: NCT02531438
• 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 First Submitted: 2015-07-14
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-24
• Study Start: 2015-11
• Primary Completion: 2017-02-05
• Study Completion: 2017-03-10
• Disposition First Submitted: 2018-02-09
• Disposition First Submitted QC: 2018-02-09
• Disposition First Posted: 2018-02-14
• Results First Submitted: 2018-11-02
• Results First Submitted QC: 2018-11-02
• Results First Posted: 2018-11-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 774

Inclusion Criteria

• Patients, ages 18 years or older who have signed the informed consent
• Has qualifying bacterial pneumonia
• Female patients 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

Exclusion Criteria

• Known or suspected hospital-acquired pneumonia
• Evidence of significant immunological disease
• Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
• Has received an investigational drug within past 30 days
• Women who are pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxifloxacin	Moxifloxacin	Moxifloxacin IV; Moxifloxacin tablets
Omadacycline	Omadacycline	Omadacycline IV; Omadacycline tablets

Primary Outcome Measures

Name	Time	Method
Number of Participants With Early Clinical Response	Screening; 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 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response was 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

Name	Time	Method
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit	Screening; 5 to 10 days after the last day of therapy	At the PTE Visit the investigator indicated 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 (CT-PTE) Population	Screening; 5 to 10 days after the last day of therapy	At the PTE Visit the investigator indicated 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.

Trial Locations

Locations (140)

Site 514; 🇺🇸 Birmingham, Alabama, United States

Site 501; 🇺🇸 Mobile, Alabama, United States

Site 508; 🇺🇸 Laguna Hills, California, United States

Site 505; 🇺🇸 Ventura, California, United States

Site 513; 🇺🇸 Stamford, Connecticut, United States

Site 511; 🇺🇸 Zachary, Louisiana, United States

Site 503; 🇺🇸 Detroit, Michigan, United States

Site 520; 🇺🇸 Saint Paul, Minnesota, United States

Site 512; 🇺🇸 Saint Louis, Missouri, United States

Site 506; 🇺🇸 Buffalo, New York, United States

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