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

This study has been completed.
Sponsor:
Information provided by:
Advanced Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT00336544
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 and safety 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 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 ] [ 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 ] [ 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 ] [ 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 ] [ Designated as safety issue: No ]

Enrollment: 522
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cethromycin Drug: Cethromycin
Cethromycin 300 mg once per day (QD) for 7 days, administered orally
Other Names:
  • Restanza
  • ABT-773
Active Comparator: Clarithromycin Drug: Clarithromycin
Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
Other Names:
  • Biaxin
  • Klacid
  • Klaracid

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336544

Locations
United States, Illinois
ARGENTINA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
CHILE - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
PERU - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
BULGARIA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
CROATIA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
ESTONIA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
GERMANY - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
HUNGARY - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
ISRAEL - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
POLAND - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
ROMANIA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
THE NETHERLANDS - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
UKRAINE - 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: NCT00336544     History of Changes
Other Study ID Numbers: CL06-001
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
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 July 20, 2014