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

NCT ID: NCT01168713

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-07-31

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.

Conditions

Community-Acquired Bacterial Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Levofloxacin

Group Type: ACTIVE_COMPARATOR

Levofloxacin

Intervention Type: DRUG

Levofloxacin once daily for 5 days:

Levofloxacin 750 mg PO Days 1-5

CEM-101

Group Type: EXPERIMENTAL

CEM-101

Intervention Type: DRUG

CEM-101 once daily for 5 days:

CEM-101 800 mg PO Day 1

CEM-101 400 mg PO Days 2-5

Interventions

Levofloxacin

Levofloxacin once daily for 5 days:

Levofloxacin 750 mg PO Days 1-5

Intervention Type: DRUG

CEM-101

CEM-101 once daily for 5 days:

CEM-101 800 mg PO Day 1

CEM-101 400 mg PO Days 2-5

Intervention Type: DRUG

Other Intervention Names

Levaquin; Solithromycin

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Flagstaff, Arizona, United States

Bell Gardens, California, United States

Chula Vista, California, United States

LeMesa, California, United States

Los Angeles, California, United States

Montclaire, California, United States

Norwalk, California, United States

Oceanside, California, United States

Oxnard, California, United States

Pasadena, California, United States

Torrence, California, United States

Waterbury, Connecticut, United States

DeBary, Florida, United States

Gainesville, Florida, United States

Hialeah, Florida, United States

Kissimmee, Florida, United States

Orlando, Florida, United States

Blue Ridge, Georgia, United States

Columbus, Georgia, United States

Savannah, Georgia, United States

Idaho Falls, Idaho, United States

Morton, Illinois, United States

Dubuque, Iowa, United States

New Orleans, Louisiana, United States

Fall River, Massachusetts, United States

New Bedford, Massachusetts, United States

Detroit, Michigan, United States

Traverse City, Michigan, United States

Butte, Montana, United States

Las Vegas, Nevada, United States

Akron, Ohio, United States

Carlisle, Ohio, United States

Eugene, Oregon, United States

West Reading, Pennsylvania, United States

Simpsonville, South Carolina, United States

Rapid City, South Dakota, United States

Franklin, Tennessee, United States

Corsicana, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Draper, Utah, United States

Magna, Utah, United States

Salt Lake City, Utah, United States

Calgary, Alberta, Canada

Hamilton, Ontario, Canada

Hamilton, Ontario, Canada

Hamilton, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Chicoutimi, Quebec, Canada

Saint-Jérôme, Quebec, Canada

Sherbrooke, Quebec, Canada

Trios-Rivieres, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 23507282 (View on PubMed)

Other Identifiers

CE01-200

Identifier Type: -

Identifier Source: org_study_id