Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Melinta Therapeutics, Inc.132 enrolled

Overview

Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.

Community-acquired bacterial pneumonia is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity again CABP pathogens. CEM-101 is the first fluoroketolide with excellent in vitro and in vivo activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Community-Acquired Bacterial Pneumonia

Interventions

LevofloxacinDRUG

Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5

CEM-101DRUG

CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of community acquired bacterial pneumonia (e.g. cough with purulent sputum or change in character of sputum consistent with bacterial infection, dyspnea or tachypnea, chest pain due to pneumonia, fever, presence of rales and/or signs of consolidation). 2. No prior systemic antibacterial therapy, unless failed other therapy. 3. Chest Xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia. 4. PORT Risk Class II, III, or IV \<=105 5. Ability to take oral medication. Exclusion Criteria: 1. Severe chronic obstructive pulmonary disease FEV1 \<30%. 2. Hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms 3. Chemotherapy or radiation therapy within the previous 3 months. 4. Significant hepatic, hematological, renal abnormalities. 5. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g. life expectancy \<30 days).

Locations (55)

Outcomes

Primary Outcomes

Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit

Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment

Time frame: 5 to 10 days after the last dose of study drug

Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit

Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment

Time frame: 5 to 10 days after the last dose of study drug

Secondary Outcomes

By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT)

Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen.

Time frame: 5 days of study drug treatment

By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit

Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

Time frame: 5 to 10 days after the last dose of study drug

By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT)

Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

Time frame: 5 days of study drug treatment

By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

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Flagstaff, Arizona, United States

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Bell Gardens, California, United States

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Chula Vista, California, United States

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LeMesa, California, United States

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Los Angeles, California, United States

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Montclaire, California, United States

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Norwalk, California, United States

Unnamed facility

Oceanside, California, United States

Unnamed facility

Oxnard, California, United States

...and 45 more locations

Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen

Time frame: 5 to 10 days after the last dose of study drug

Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT)

Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

Time frame: 5 days of study drug treatment

Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT)

Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

Time frame: 5 days of study drug treatment

Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT)

Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

Time frame: 5 days of study drug treatment

Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT)

Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP

Time frame: 5 days of study drug treatment

Early Clinical Response in the intent to treat (ITT) population at Day 3

Clinical success is defined as being both clinically stable and showing clinical improvement based on the symptoms of community acquired bacterial pneumonia (CABP)

Time frame: 3 days of study drug treatment

Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population

Resolution of all baseline signs and symptoms in the clinically evaluable (CE) population

Time frame: Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit)

Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

Resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

Time frame: 3 days of study drug treatment

Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

resolution of cough, dyspnea, chest pain due to pneumonia and sputum production

Time frame: 5 days of study drug treatment

Percentage of patients at Day 3 who are clinically stable

clinical stability defined as: * Temperature \<=37.8°C * Heart rate \<=100 beats/min * Systolic blood pressure ≥90 mm Hg * Ability to maintain oral intake * Normal mental status (oriented to person, place or time)

Time frame: 3 days of study drug treatment

Percentage of patients at the end of treatment (EOT) who are clinically stable

Clinically stable defined as: * Temperature ≤37.8°C * Heart rate ≤100 beats/min * Systolic blood pressure ≥90 mm Hg * Ability to maintain oral intake * Normal mental status (oriented to person, place or time)

Time frame: 5 days of study drug treatment