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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00336544
• Date of registration: 09/06/2006
• Primary sponsor: Advanced Life Sciences, Inc.
• Public title: Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia
• Scientific 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
• Date of first enrolment: June 2006
• Target sample size: 522
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00336544
• 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

Countries of recruitment

United States

Contacts

• Name: David A. Eiznhamer, PhD.
• Affiliation: Advanced Life Sciences

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pneumonia

Intervention(s)

Drug: Cethromycin

Drug: Clarithromycin

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

CL06-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors