Trial Outcomes & Findings for Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia (NCT NCT04779242)

Last Updated: 2025-04-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

670 participants

Primary outcome timeframe

72 to 120 hours after the first dose of test article

Results posted on

2025-04-09

Participant Flow

This is a randomized, double-blind, active comparator-controlled study comparing Omadacycline and Moxifloxacin with participants with Community-Acquired Bacterial Pneumonia (CABP). The randomization was stratified by Pneumonia Outcomes Research Team (PORT) Risk Class (III or IV), and receipt of an allowed antibacterial therapy in the 72 hours prior to study treatment.

A total of 670 participants were enrolled in approximately 75 sites globally.

Participant milestones

Participant milestones
Measure	Omadacycline Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.
Overall Study STARTED	336	334
Overall Study COMPLETED	308	306
Overall Study NOT COMPLETED	28	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Omadacycline Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	7	9
Overall Study Death	6	6
Overall Study COVID-19 related reasons	2	1
Overall Study Unavailability for post therapy evaluation Visit	8	4
Overall Study Martial Law in Ukraine	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omadacycline n=336 Participants Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin n=334 Participants Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.	Total n=670 Participants Total of all reporting groups
Age, Continuous	63.3 Years STANDARD_DEVIATION 14.41 • n=5 Participants	62.2 Years STANDARD_DEVIATION 15.42 • n=7 Participants	62.8 Years STANDARD_DEVIATION 14.92 • n=5 Participants
Sex: Female, Male Female	158 Participants n=5 Participants	166 Participants n=7 Participants	324 Participants n=5 Participants
Sex: Female, Male Male	178 Participants n=5 Participants	168 Participants n=7 Participants	346 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	332 Participants n=5 Participants	330 Participants n=7 Participants	662 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	335 Participants n=5 Participants	333 Participants n=7 Participants	668 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 72 to 120 hours after the first dose of test article

Population: ITT population

Outcome measures

Outcome measures
Measure	Omadacycline n=336 Participants Participants received Omadacycline 200 mg intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin n=334 Participants Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit Clinical Success	89.6 Percentage of participants	87.7 Percentage of participants
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit Clinical Failure	8.6 Percentage of participants	9.3 Percentage of participants
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit Indeterminate	1.8 Percentage of participants	3.0 Percentage of participants

SECONDARY outcome

Timeframe: 5 to 10 days after the last dose of test article

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Omadacycline n=336 Participants Participants received Omadacycline 200 mg intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin n=334 Participants Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.
Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit Clinical Success	86 Percentage of participants	87.7 Percentage of participants
Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit Clinical Failure	8.0 Percentage of participants	6.6 Percentage of participants
Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit Indeterminate	6.0 Percentage of participants	5.7 Percentage of participants

SECONDARY outcome

Timeframe: 5 to 10 days after the last dose of test article

Population: CE-PTE Population consisted of all ITT participants who received test article, have a qualifying Community-Acquired Bacterial Pneumonia (CABP), an assessment of outcome, and meet all other evaluability criteria.

Outcome measures

Outcome measures
Measure	Omadacycline n=273 Participants Participants received Omadacycline 200 mg intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin n=271 Participants Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.
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 Clinical Success	94.1 Percentage of participants	95.9 Percentage of participants
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 Clinical Failure	5.9 Percentage of participants	4.1 Percentage of participants
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 Indeterminate	0 Percentage of participants	0 Percentage of participants

Adverse Events

Omadacycline

Serious events: 17 serious events

Other events: 32 other events

Deaths: 6 deaths

Moxifloxacin

Serious events: 15 serious events

Other events: 36 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Omadacycline n=336 participants at risk Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin n=332 participants at risk Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.
Infections and infestations COVID-19	3.3% 11/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	1.2% 4/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Investigations Aspartate aminotransferase increased	2.1% 7/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Nervous system disorders Headache	3.6% 12/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	4.5% 15/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Gastrointestinal disorders Diarrhoea	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	3.0% 10/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Psychiatric disorders Insomnia	0.60% 2/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	2.1% 7/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)

Additional Information

Paratek Medical Information

Paratek Pharmaceuticals Inc

Phone: 1-833-727-2835

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Omadacycline n=336 participants at risk Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10.	Moxifloxacin n=332 participants at risk Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10.
Cardiac disorders Atrial fibrillation	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Cardiac disorders Cardiac failure	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.60% 2/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Cardiac disorders Cardiogenic shock	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Cardiac disorders Pericardial effusion	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Cardiac disorders Cardiac arrest	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.60% 2/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Cardiac disorders Cardiopulmonary failure	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
General disorders Death	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
General disorders Multiple organ dysfunction syndrome	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations Pneumonia	0.60% 2/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.60% 2/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations COVID-19	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.60% 2/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations Infectious pleural effusion	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations Septic shock	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations Urinary tract infection	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations Empyema	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations Lung abscess	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Infections and infestations Pyoderma streptococcal	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Nervous system disorders Cerebral infarction	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Nervous system disorders Epilepsy	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Psychiatric disorders Psychotic disorder	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Renal and urinary disorders Ureterolithiasis	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.30% 1/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.00% 0/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.60% 2/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/336 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)	0.30% 1/332 • Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)