ClinicalTrials.Veeva

Menu

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

Melinta Therapeutics logo

Melinta Therapeutics

Status and phase

Completed
Phase 2

Conditions

Community-Acquired Bacterial Pneumonia

Treatments

Drug: CEM-101
Drug: Levofloxacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01168713
CE01-200

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

132 participants in 2 patient groups

Levofloxacin
Active Comparator group
Treatment:
Drug: Levofloxacin
CEM-101
Experimental group
Treatment:
Drug: CEM-101

Trial contacts and locations

55

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems