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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cempra Inc; Melinta Therapeutics, Inc.
• Treatments: Levofloxacin; Ofloxacin; Solithromycin

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).