Overview

PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis

Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
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 (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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Telithromycin
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

- 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 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