Clinical trial NCT01168713: Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
Official title: A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired Bacterial Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Community-Acquired Bacterial Pneumonia
Keywords: Adults with Community-Acquired Bacterial Pneumonia
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit
timeFrame: 5 to 10 days after the last dose of study drug
measure: Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit
timeFrame: 5 to 10 days after the last dose of study drug
Secondary outcomes:
measure: By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT)
timeFrame: 5 days of study drug treatment
measure: By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit
timeFrame: 5 to 10 days after the last dose of study drug
measure: By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT)
timeFrame: 5 days of study drug treatment
measure: By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit
timeFrame: 5 to 10 days after the last dose of study drug
measure: Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT)
timeFrame: 5 days of study drug treatment
measure: Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT)
timeFrame: 5 days of study drug treatment
measure: Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT)
timeFrame: 5 days of study drug treatment
measure: Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT)
timeFrame: 5 days of study drug treatment
measure: Early Clinical Response in the intent to treat (ITT) population at Day 3
timeFrame: 3 days of study drug treatment
measure: Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population
timeFrame: Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit)
measure: Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production
timeFrame: 3 days of study drug treatment
measure: Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production
timeFrame: 5 days of study drug treatment
measure: Percentage of patients at Day 3 who are clinically stable
timeFrame: 3 days of study drug treatment
measure: Percentage of patients at the end of treatment (EOT) who are clinically stable
timeFrame: 5 days of study drug treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Flagstaff
country: United States
state: Arizona
city: Bell Gardens
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: LeMesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Montclaire
country: United States
state: California
city: Norwalk
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Torrence
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Debary
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Blue Ridge
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Morton
country: United States
state: Illinois
city: Dubuque
country: United States
state: Iowa
city: New Orleans
country: United States
state: Louisiana
city: Fall River
country: United States
state: Massachusetts
city: New Bedford
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Akron
country: United States
state: Ohio
city: Carlisle
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: West Reading
country: United States
state: Pennsylvania
city: Simpsonville
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Franklin
country: United States
state: Tennessee
city: Corsicana
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Draper
country: United States
state: Utah
city: Magna
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Calgary
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St. Jerome
country: Canada
state: Quebec
city: Trios-Rivieres
country: Canada
state: Quebec
Study officials:
References:
citation: 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.