Clinical trial NCT00336544: Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: Pneumonia
Respiratory
Infection
Infectious
Advanced
Life
Sciences
Lung
Pulmonary
Cethromycin
Clarithromycin
Biaxin
Lead sponsor: Advanced Life Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-13
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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)

Primary outcomes:
measure: Clinical Cures in the Intent to Treat Population
timeFrame: Test of Cure Visit, defined as 14-22 days after the first dose of study
measure: Clinical Cures in the Per Protocol Clinically Evaluable Population
timeFrame: Test of Cure Visit, defined as 14-22 days after the first dose of study
Secondary outcomes:
measure: Bacteriologic Cures in the Intent to Treat Population
timeFrame: Test of Cure Visit, defined as 14-22 days after the first dose of study
measure: Bacteriologic Cures in the Per Protocol Clinically Evaluable Population
timeFrame: Test of Cure Visit, defined as 14-22 days after the first dose of study
Other outcomes:
Locations:
city: Woodridge
country: United States
facility: ARGENTINA - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: BULGARIA - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: CHILE - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: CROATIA - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: ESTONIA - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: GERMANY - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: HUNGARY - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: ISRAEL - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: PERU - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: POLAND - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: ROMANIA - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: THE NETHERLANDS - Advanced Life Sciences
state: Illinois
city: Woodridge
country: United States
facility: UKRAINE - Advanced Life Sciences
state: Illinois
Study officials:
affiliation: Advanced Life Sciences
name: David A. Eiznhamer, PhD.
role: STUDY_DIRECTOR
References: