to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides at the Test Of Cure visit in the sputum of patients with Sp detected at the start of the study

Condition	Intervention	Phase
Chronic Bronchitis	Drug: telithromycin	Phase IV

Ages Eligible for Study:  35 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Patients meeting all of the following criteria will be considered for enrollment into the study:

• Outpatients, male or female, aged 35 years or older
• Patient with a documented history of chronic bronchitis, characterized by cough and excessive sputum production for most days of at least three months for 2 consecutive years, And
• Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis, presumed due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume;
• Patients producing spontaneous sputum;
• Patients with three or less AECB in the previous 12 months

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 reaction to the study medication, or to ß-lactams or macrolides 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, phenytoïn, carbamazepine, phenobarbital, and St John’s Wort;
• Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol (see section 6.2);
• Patients known to have impaired hepatic function;
• Patients known to have impaired renal function;
• Patients already enrolled in this study The investigator and the sponsor can, on a case-by-case basis prior to enrolling the patient, approve any waiver of these inclusion and exclusion criteria. Both the sponsor and the investigator must document the inclusion waiver.

Please refer to this study by ClinicalTrials.gov identifier  NCT00132938

Public Registry USMA       PublicRegistryUSMA@ sanofi-aventis.com

New Jersey
      Sanofi-Aventis, Inc, Bridgewater,  New Jersey,  08807,  United States; Recruiting

Study chairs or principal investigators

Phyllis Diener, BS, MT (ASCP),  Study Director,  sanofi-aventis, inc.   

Study ID Numbers:  HMR3647A/4020
Last Updated:  August 22, 2005
Record first received:  August 18, 2005
ClinicalTrials.gov Identifier:  NCT00132938
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23