Community-Acquired Bacterial Pneumonia
Conditions
Keywords
Adults with Community-Acquired Bacterial Pneumonia
Brief summary
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.
Detailed description
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.
Interventions
DRUGLevofloxacin
Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5
DRUGCEM-101
CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5
Sponsors
Melinta Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | 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 |
| Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit | 5 to 10 days after the last dose of study drug | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT) | 5 days of study drug treatment | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT) | 5 days of study drug treatment | 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 |
| Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT) | 5 days of study drug treatment | 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 |
| Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT) | 5 days of study drug treatment | 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 |
| Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT) | 5 days of study drug treatment | 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 |
| By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT) | 5 days of study drug treatment | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen. |
| Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population | Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit) | Resolution of all baseline signs and symptoms in the clinically evaluable (CE) population |
| Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production | 3 days of study drug treatment | Resolution of cough, dyspnea, chest pain due to pneumonia and sputum production |
| Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production | 5 days of study drug treatment | resolution of cough, dyspnea, chest pain due to pneumonia and sputum production |
| Percentage of patients at Day 3 who are clinically stable | 3 days of study drug treatment | 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) |
| Percentage of patients at the end of treatment (EOT) who are clinically stable | 5 days of study drug treatment | 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) |
| Early Clinical Response in the intent to treat (ITT) population at Day 3 | 3 days of study drug treatment | Clinical success is defined as being both clinically stable and showing clinical improvement based on the symptoms of community acquired bacterial pneumonia (CABP) |
| By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
Countries
Canada, United States
Outcome results
None listed