Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia (CAP)

This study has been completed.
Sponsor:
Information provided by:
Advanced Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT00336505
First received: June 9, 2006
Last updated: January 29, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).


Condition Intervention Phase
Pneumonia
Drug: Cethromycin
Drug: Clarithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blinded, Randomized, Parallel Group, Multi-Center, Multi-National Comparative Study of the Safety and Efficacy of Cethromycin 300 mg QD to Clarithromycin (BIAXIN® Filmtab®) 250 mg BID for the Treatment of Community-Acquired Pneumonia in Adults

Resource links provided by NLM:


Further study details as provided by Advanced Life Sciences, Inc.:

Primary Outcome Measures:
  • Clinical Cures in the Intent to Treat Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study drug. ] [ Designated as safety issue: No ]
  • Clinical Cures in the Per Protocol Clinically Evaluable Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bacteriologic Cures in the Intent to Treat Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study drug. ] [ Designated as safety issue: No ]
  • Bacteriologic Cures in the Per Protocol Clinically Evaluable Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study drug. ] [ Designated as safety issue: No ]

Enrollment: 584
Study Start Date: December 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clarithromycin Drug: Clarithromycin
Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
Other Names:
  • clarithromycin
  • Biaxin
  • Klacid
  • Klaracid
Experimental: Cethromycin Drug: Cethromycin
Cethromycin 300 mg once per day (QD) for 7 days, administered orally
Other Names:
  • cethromycin
  • Restanza
  • ABT-773

Detailed Description:

Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. In this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory male or female, 18 years of age or older
  • If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
  • Positive Chest X-ray consistent with diagnosis of bacterial pneumonia
  • Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact
  • Recent history of respiratory illness consistent with the clinical signs and symptoms of bacterial CAP
  • Must be able to produce sputum

Exclusion Criteria:

  • Prior hospitalization within previous 4 weeks
  • Residence at a chronic care facility
  • Active tuberculosis (or other mycobacterial infection, empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or metastatic) involving the lung, bronchial obstruction, a history of post-obstructive pneumonia (chronic obstructive pulmonary disease [COPD] is not exclusionary), known or suspected Pneumocystis carinii pneumonia
  • Treatment with long-acting antimicrobial agents within the last 4 weeks, treatment with ceftriaxone, azithromycin or dirithromycin antibiotic within the last 7 days, or subjects who have received more than 24 hours of treatment with other antibiotics within 7 days prior to study drug administration
  • Any infection which requires the use of a concomitant antimicrobial agent
  • History of hypersensitivity or allergic reactions to macrolide, ketolide, quinolone, azalide or streptogramin antimicrobials
  • Treatment with another investigational drug within the last 4 weeks
  • Females who are pregnant or lactating
  • Subjects with known significant renal or hepatic impairment or disease
  • Subjects with a history of impaired renal function
  • Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied)
  • Subjects who would require parenteral antimicrobial therapy for the treatment of pneumonia
  • Any underlying disease or condition that would interfere with the completion of the study procedures and evaluations or absorption of the study drug
  • Currently receiving or are likely to require any of the following medications during the period between 2 weeks prior to Evaluation 1 and within 24 hours after the last dose of study drug: astemizol (Hismanal®) or pimozide (Orap®)
  • Currently receiving or are likely to require any of the following during the period from Evaluation 1 and within 24 hours after the last dose of study drug: theophylline or theophylline analogues (unless adequately monitored), carbamazepine, dexamethasone, phenobarbital, phenytoin, St. John's Wort, lamotrigine, troglitazone, warfarin and digitalis glycoside. Other barbiturates may be used with careful monitoring
  • Subjects who are currently receiving or who are likely to require any of the following medications during the period between Evaluation 1 and 4: other systemic antibiotic therapy, rifampin or rifabutin
  • Immunocompromised subjects, subjects receiving immunosuppressive agents, subjects with known human immunodeficiency virus (HIV) infections and history of acquired immune deficiency syndrome (AIDS) defining conditions or CD4+ T-lymphocyte count <200.
  • Subject with known or suspected central nervous system (CNS) disorder that predisposes them to seizures/lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy)
  • Previous treatment with cethromycin
  • Subjects with signs of septic shock (e.g., mental confusion, severe hypoxemia, severe hypotension, any other condition requiring intensive care unit [ICU] admission)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336505

Locations
United States, Illinois
USA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
CANADA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
SOUTH AFRICA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
Sponsors and Collaborators
Advanced Life Sciences, Inc.
Investigators
Study Director: David A. Eiznhamer, PhD Advanced Life Sciences
  More Information

No publications provided

Responsible Party: David Eiznhamer, PhD, Executive Vice President, Clinical Development, Advanced Life Sciences
ClinicalTrials.gov Identifier: NCT00336505     History of Changes
Other Study ID Numbers: CL05-001
Study First Received: June 9, 2006
Results First Received: September 3, 2009
Last Updated: January 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Life Sciences, Inc.:
Pneumonia
Respiratory
Infection
Infectious
Advanced
Life
Sciences
Lung
Pulmonary
Cethromycin
Restanza
Clarithromycin
Biaxin

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Clarithromycin
Cethromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014