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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin | Active Comparator |
| |
| CEM-101 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 5 to 10 days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35242 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23507282 | Derived | Oldach D, Clark K, Schranz J, Das A, Craft JC, Scott D, Jamieson BD, Fernandes P. Randomized, double-blind, multicenter phase 2 study comparing the efficacy and safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the treatment of patients with community-acquired bacterial pneumonia. Antimicrob Agents Chemother. 2013 Jun;57(6):2526-34. doi: 10.1128/AAC.00197-13. Epub 2013 Mar 18. |
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| CEM-101 | Drug | CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5 |
|
|
Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| 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 | 5 days of study drug treatment |
| By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 5 days of study drug treatment |
| Percentage of patients at Day 3 who are clinically stable | clinical stability defined as:
| 3 days of study drug treatment |
| Percentage of patients at the end of treatment (EOT) who are clinically stable | Clinically stable defined as:
| 5 days of study drug treatment |
| Flagstaff |
| Arizona |
| 86001 |
| United States |
| Bell Gardens | California | 90201 | United States |
| Chula Vista | California | 91911 | United States |
| LeMesa | California | 91942 | United States |
| Los Angeles | California | 90015 | United States |
| Montclaire | California | 91763 | United States |
| Norwalk | California | 90650 | United States |
| Oceanside | California | 92056 | United States |
| Oxnard | California | 93030 | United States |
| Pasadena | California | 91105 | United States |
| Torrence | California | 90501 | United States |
| Waterbury | Connecticut | 06708 | United States |
| DeBary | Florida | 32713 | United States |
| Gainesville | Florida | 32605 | United States |
| Hialeah | Florida | 33012 | United States |
| Kissimmee | Florida | 34741 | United States |
| Orlando | Florida | 32837 | United States |
| Blue Ridge | Georgia | 30513 | United States |
| Columbus | Georgia | 31904 | United States |
| Savannah | Georgia | 31406 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Morton | Illinois | 61550 | United States |
| Dubuque | Iowa | 52001 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Fall River | Massachusetts | 02720 | United States |
| New Bedford | Massachusetts | 02740 | United States |
| Detroit | Michigan | 48202 | United States |
| Traverse City | Michigan | 49684 | United States |
| Butte | Montana | 59701 | United States |
| Las Vegas | Nevada | 89109 | United States |
| Akron | Ohio | 44304 | United States |
| Carlisle | Ohio | 45005 | United States |
| Eugene | Oregon | 97404 | United States |
| West Reading | Pennsylvania | 19611 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Rapid City | South Dakota | 57702 | United States |
| Franklin | Tennessee | 37067 | United States |
| Corsicana | Texas | 75110 | United States |
| Houston | Texas | 77002 | United States |
| Houston | Texas | 77093 | United States |
| San Antonio | Texas | 78238 | United States |
| Draper | Utah | 84020 | United States |
| Magna | Utah | 84044 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Calgary | Alberta | T2N2T9 | Canada |
| Hamilton | Ontario | L8N3Z5 | Canada |
| Hamilton | Ontario | L8N4A6 | Canada |
| Hamilton | Ontario | L8V1C3 | Canada |
| Ottawa | Ontario | K1Y 4E9 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Chicoutimi | Quebec | G7H-5H6 | Canada |
| Saint-Jérôme | Quebec | J7Z5T3 | Canada |
| Sherbrooke | Quebec | J1H5N4 | Canada |
| Trios-Rivieres | Quebec | G8Z3R9 | Canada |
| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| C547755 | solithromycin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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