PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis

Completed · Phase 4

Conditions studied: Chronic Bronchitis

In brief

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 (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1). Secondary Objectives: The secondary objectives of the study are: * To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1); * To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits; * To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1); * To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.

Key facts

Study ID: NCT00132938
Run by: Sanofi
People needed: 5660
Starts: 2004-01-01
Expected to finish: 2006-05-01
Last updated by the study team: 2011-06-08

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Sanofi-Aventis — Bridgewater, New Jersey, United States
Sanofi-Aventis — Brussels, Belgium
Sanofi-Aventis — Paris, France
Sanofi-Aventis — Budapest, Hungary
Sanofi-Aventis — Casablanca, Morocco
Sanofi-Aventis — Barcelona, Spain
Sanofi-Aventis — Mégrine, Tunisia
Sanofi-Aventis — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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