Status:
COMPLETED
PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis
Lead Sponsor:
Sanofi
Conditions:
Chronic Bronchitis
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief Summary
Primary Objective: * The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (S...
Eligibility Criteria
Inclusion
- Patients meeting all of the following criteria will be considered for enrollment into the study:
- Outpatients, male or female, aged 35 years or older
- Patients 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
- Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis (AECB), 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
5660 Patients enrolled
Trial Details
Trial ID
NCT00132938
Start Date
January 1 2004
End Date
May 1 2006
Last Update
June 8 2011
Active Locations (8)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States
2
Sanofi-Aventis
Brussels, Belgium
3
Sanofi-Aventis
Paris, France
4
Sanofi-Aventis
Budapest, Hungary