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

Condition(s) targeted: Pneumonia

Intervention: Cethromycin (Drug); Clarithromycin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Advanced Life Sciences, Inc.

Official(s) and/or principal investigator(s):
David A. Eiznhamer, PhD., Study Director, Affiliation: Advanced Life Sciences

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).

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical Cure Rate

Secondary outcome: Bacteriologic Cure Rate

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 (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 HIV infections and history of AIDS defining conditions or CD4+ T-lymphocyte count <200.

- Subject with known or suspected 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 ICU admission)

ARGENTINA - Advanced Life Sciences, Woodridge, Illinois 60517, United States

CHILE - Advanced Life Sciences, Woodridge, Illinois 60517, United States

PERU - Advanced Life Sciences, Woodridge, Illinois 60517, United States

BULGARIA - Advanced Life Sciences, Woodridge, Illinois 60517, United States

CROATIA - Advanced Life Sciences, Woodridge, Illinois 60517, United States

ESTONIA - Advanced Life Sciences, Woodridge, Illinois 60517, United States

GERMANY - Advanced Life Sciences, Woodridge, Illinois 60517, United States

HUNGARY - Advanced Life Sciences, Woodridge, Illinois 60517, United States

ISRAEL - Advanced Life Sciences, Woodridge, Illinois 60517, United States

POLAND - Advanced Life Sciences, Woodridge, Illinois 60517, United States

ROMANIA - Advanced Life Sciences, Woodridge, Illinois 60517, United States

THE NETHERLANDS - Advanced Life Sciences, Woodridge, Illinois 60517, United States

UKRAINE - Advanced Life Sciences, Woodridge, Illinois 60517, United States

Starting date: June 2006
Ending date: December 2006
Last updated: March 26, 2007