Omadacycline vs Moxifloxacin for the Treatment of CABP (E... | NCT02531438

NCT02531438

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omadacycline	Experimental	Omadacycline IV; Omadacycline tablets	Drug: Omadacycline
Moxifloxacin	Active Comparator	Moxifloxacin IV; Moxifloxacin tablets	Drug: Moxifloxacin

Name	Type	Description	Arm Group Labels	Other Names
Omadacycline	Drug	Injection for IV; Oral tablets	Omadacycline
Moxifloxacin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Early Clinical Response	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.	Screening; 72 to 120 hours after the first dose of test article

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit	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.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Site 514		Birmingham	Alabama	35215	United States
Site 501

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37575994	Derived	Rodriguez GD, Warren N, Yashayev R, Chitra S, Amodio-Groton M, Wright K. Omadacycline in the treatment of community-acquired bacterial pneumonia in patients with comorbidities: a post-hoc analysis of the phase 3 OPTIC trial. Front Med (Lausanne). 2023 Jul 28;10:1225710. doi: 10.3389/fmed.2023.1225710. eCollection 2023.
35776862

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Omadacycline	Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 17, 2017

Arm/Group Information

ID	Title	Description
BG000	Omadacycline	Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
BG001	Moxifloxacin	Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

18 to 45 years old

Title	Measurements
	BG00062 BG00161 BG002123

>45 to 65 years old

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000178 BG001169 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0012 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Early Clinical Response

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.

Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not the participant received the test article

Posted

Count of Participants

Participants

Screening; 72 to 120 hours after the first dose of test article

ID	Title	Description
OG000	Omadacycline	Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
OG001	Moxifloxacin	Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.

Units	Counts
Participants	OG000386 OG001388

Title

Denominators

Categories

Clinical success

Title	Measurements
	OG000313 OG001321

Clinical failure

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						treatment difference	-1.6			2-Sided	95	-7.1	3.8			The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.		Non-Inferiority	A non-inferiority margin of 10% was used for the analysis.

Secondary

Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit

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.

ITT Population

Posted

Count of Participants

Participants

Screening; 5 to 10 days after the last day of therapy

ID	Title	Description
OG000	Omadacycline	Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.

Secondary

Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population

CE-PTE Population: all participants in the ITT Population meeting additional pre-defined criteria

Posted

Count of Participants

Participants

Screening; 5 to 10 days after the last day of therapy

ID	Title	Description
OG000	Omadacycline	Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Omadacycline	Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.	8	382	23	382	63	382
EG001	Moxifloxacin	Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.	4	388	26	388	94	388

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Myocardial Infarction	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected382 at risk EG0010 affected388 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected382 at risk EG0011 affected388 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Cardiac Failure	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0011 affected388 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Tachycardia	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Pericardial Effusion	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Multi-Organ Failure	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Hepatic Congestion	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Influenza	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0003 affected382 at risk EG0010 affected388 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 affected382 at risk EG0016 affected388 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Infectious Pleural Effusion	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0011 affected388 at risk
Septic Shock	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0012 affected388 at risk
Atypical Mycobacterial Pneumonia	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0012 affected388 at risk
human Immunodeficiency Virus (HIV) Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Infective Exacerbation Of Bronchiectasis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Lung Abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Pneumonia Viral	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Bladder Injury	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0002 affected382 at risk EG0012 affected388 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Chronic Lymphocytic Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected382 at risk EG0010 affected388 at risk
Anxiety	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0012 affected388 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 affected382 at risk EG0010 affected388 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected382 at risk EG0010 affected388 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 affected382 at risk EG0013 affected388 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Aortic Aneurysm Rupture	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected382 at risk EG0010 affected388 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected382 at risk EG0011 affected388 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00010 affected382 at risk EG0016 affected388 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0009 affected382 at risk EG0016 affected388 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0009 affected382 at risk EG00121 affected388 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 affected382 at risk EG00131 affected388 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG00014 affected382 at risk EG00118 affected388 at risk
Gamma-glutamyl transferase increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG00010 affected382 at risk EG0018 affected388 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0008 affected382 at risk EG00114 affected388 at risk
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0008 affected382 at risk EG0015 affected388 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG00010 affected382 at risk EG0018 affected388 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG00013 affected382 at risk EG00111 affected388 at risk

ID	Term
D018410	Pneumonia, Bacterial
D017714	Community-Acquired Infections

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds