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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336544
• Other study ID #: CL06-001
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2006
• Last updated: January 29, 2010
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2010
• Source: Advanced Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• Cethromycin
Cethromycin 300 mg once per day (QD) for 7 days, administered orally
• Clarithromycin
Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally

Locations

Country	Name	City	State
United States	ARGENTINA - Advanced Life Sciences	Woodridge	Illinois
United States	BULGARIA - Advanced Life Sciences	Woodridge	Illinois
United States	CHILE - Advanced Life Sciences	Woodridge	Illinois
United States	CROATIA - Advanced Life Sciences	Woodridge	Illinois
United States	ESTONIA - Advanced Life Sciences	Woodridge	Illinois
United States	GERMANY - Advanced Life Sciences	Woodridge	Illinois
United States	HUNGARY - Advanced Life Sciences	Woodridge	Illinois
United States	ISRAEL - Advanced Life Sciences	Woodridge	Illinois
United States	PERU - Advanced Life Sciences	Woodridge	Illinois
United States	POLAND - Advanced Life Sciences	Woodridge	Illinois
United States	ROMANIA - Advanced Life Sciences	Woodridge	Illinois
United States	THE NETHERLANDS - Advanced Life Sciences	Woodridge	Illinois
United States	UKRAINE - Advanced Life Sciences	Woodridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cures in the Intent to Treat Population		Test of Cure Visit, defined as 14-22 days after the first dose of study	No
Primary	Clinical Cures in the Per Protocol Clinically Evaluable Population		Test of Cure Visit, defined as 14-22 days after the first dose of study	No
Secondary	Bacteriologic Cures in the Intent to Treat Population		Test of Cure Visit, defined as 14-22 days after the first dose of study	No
Secondary	Bacteriologic Cures in the Per Protocol Clinically Evaluable Population		Test of Cure Visit, defined as 14-22 days after the first dose of study	No