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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01168713
• Date of registration: 22/07/2010
• Prospective Registration: Yes
• Primary sponsor: Cempra Inc
• Public title: Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
• Scientific 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
• Date of first enrolment: August 2010
• Target sample size: 132
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01168713
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Community-Acquired Bacterial Pneumonia

Intervention(s)

Drug: CEM-101

Drug: Levofloxacin

Primary Outcome(s)

Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit [Time Frame: 5 to 10 days after the last dose of study drug]

Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit [Time Frame: 5 to 10 days after the last dose of study drug]

Secondary Outcome(s)

By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit [Time Frame: 5 to 10 days after the last dose of study drug]

By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit [Time Frame: 5 to 10 days after the last dose of study drug]

Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT) [Time Frame: 5 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 [Time Frame: 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 the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [Time Frame: 5 days of study drug treatment]

Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT) [Time Frame: 5 days of study drug treatment]

Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT) [Time Frame: 5 days of study drug treatment]

Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT) [Time Frame: 5 days of study drug treatment]

By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT) [Time Frame: 5 days of study drug treatment]

Percentage of patients at the end of treatment (EOT) who are clinically stable [Time Frame: 5 days of study drug treatment]

By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT) [Time Frame: 5 days of study drug treatment]

Early Clinical Response in the intent to treat (ITT) population at Day 3 [Time Frame: 3 days of study drug treatment]

Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [Time Frame: 3 days of study drug treatment]

Percentage of patients at Day 3 who are clinically stable [Time Frame: 3 days of study drug treatment]

Secondary ID(s)

CE01-200

Source(s) of Monetary Support

Please refer to primary and secondary sponsors