Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia (CAP)
Condition: Pneumonia
MeSH terms: Pneumonia
Intervention: Cethromycin; Clarithromycin
Intervention description: Cethromycin 300 mg once per day (QD) for 7 days, administered orally; Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
Intervention MeSH terms: Clarithromycin; Cethromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 584.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia; Respiratory; Infection; Infectious; Advanced; Life; Sciences; Lung; Pulmonary; Cethromycin; Restanza; Clarithromycin; Biaxin

Summary:

      The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the
      treatment of mild to moderate community-acquired pneumonia (CAP).
    

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)