PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis

Exclusion Criteria

• •Patients presenting with any of the following will not be included in the study:
• •Patients with a known diagnosis of bronchiectasis; cystic fibrosis; lung cancer or lung metastases; active pulmonary tuberculosis; or with suspected pneumonia.
• •Patients with present acute respiratory failure or patients requiring aggressive airway management
• •Hospitalized patients and patients from institutional care facilities
• •Patients treated with antibiotics within 14 days prior to enrollment
• •Patients who are receiving other medications, including systemic antimicrobial agents; or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety.
• •Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results difficult
• •Patients with a progressively fatal disease, or life expectancy ≤ three months
• •Patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period
• •Patients with a recent (within the previous three months) history of alcohol or drug abuse
• •Immunocompromised patients including, but not limited to: patients with known HIV infection (CD4 + \<200/mm3); known neutropenia (\<1500 neutrophils/mm3); chronic corticosteroid therapy (≥ 10mg/day prednisolone equivalent during at least three months); immunodepressant treatment within the previous six months; splenectomized patients or patients with known hyposplenia or asplenia.
• •Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
• •Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study
• •Patients having received anti-pneumococcal immunization in the previous six months before study entry
• •Patients with suspected or known hypersensitivity to, or suspected serious adverse reactions to the study medication, or to ß-lactams or macrolide classes of antibiotics
• •Patients diagnosed with myasthenia gravis
• •Women who are breast-feeding or who are pregnant
• •Women who are of childbearing potential who do not agree to use an approved contraceptive method during the study
• •Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption
• •Patients with a known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia)
• •Patients treated within 2 weeks prior to study entry, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, and St John's wort
• •Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol
• •Patients known to have impaired hepatic function
• •Patients known to have impaired renal function
• •Patients already enrolled in this study