Status:
TERMINATED
KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections
Lead Sponsor:
Sanofi
Conditions:
Respiratory Tract Infections
Chronic Bronchitis
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exace...
Eligibility Criteria
Inclusion
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- Male and female adult outpatient subjects diagnosed with AECB or CAP
- Female subjects must be either postmenopausal for ≥ 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow ≤ 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control.
- Informed consent must be obtained in writing for all subjects upon enrollment.
- Subjects will have a diagnosis of AECB or CAP, as defined below.
- AECB-Specific
- Subjects greater than or equal to 35 years of age
- Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) \< 70% and \> 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) \< 70%.
- Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume
- Subjects producing spontaneous sputum
- Subjects with a ≥ 10 pack-year history of cigarette smoking
- CAP-Specific
- Fever (oral temperature \> 38°C \[100.4°F\] or tympanic temperature \> 38.5°C \[101.2°F\] or rectal temperature \> 39°C \[102.2°F\])
- Chills
- Pleuritic chest pain
- Cough
- Spontaneous production of purulent sputum or a change in sputum character
- Auscultatory findings (such as rales \[also known as crepitations\] and/or evidence of pulmonary consolidation \[ie, dullness on percussion, bronchial breath sounds, egophony\])
- Subjects greater than or equal to 18 years of age
- Chest x-ray findings that support a clinical diagnosis of bacterial pneumonia (eg, presence of presumably new infiltrate\[s\])
- Subjects with a clinical diagnosis of mild to moderate CAP due to bacterial infection based on at least 1 of the following signs and symptoms of CAP:
- In addition, subjects with a clinical diagnosis of CAP will have at least 1 of the following signs and symptoms of CAP:
- Dyspnea or tachypnea (particularly if progressive in nature)
Exclusion
- Subjects presenting with any of the following will not be included in the study:
- Subjects with a known history of congenital long-QTc syndrome
- Subjects who are pregnant or breast-feeding
- Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics
- Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study
- Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax)
- Subjects who have previously participated in this study
- Subjects with a previous history of myasthenia gravis
- Subjects with current acute respiratory failure or subjects who require aggressive airway management
- Hospitalized subjects and subjects from institutional care facilities
- Subjects who have been treated with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than study drug during the treatment period
- Subjects 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
- Subjects with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that makes either implementation of the protocol or interpretation of the study results difficult
- Subjects with a progressively fatal disease or life expectancy of \< 3 months
- Subjects who have received any other investigational drug or device within 1 month prior to study entry, or who have such treatment planned during the study period
- Subjects with a recent (within 3 months) history of drug or alcohol abuse
- Immunocompromised subjects, including but not limited to subjects with: known human immunodeficiency virus infection (CD4 count \< 200/mm3); known neutropenia (\< 1500 neutrophils/mm3); chronic corticosteroid therapy (≥ 10 mg/day prednisolone therapy or equivalent for at least the past 3 months); immunosuppressant treatment, other than corticosteroids, within the previous 6 months; splenectomized subjects or subjects with known hyposplenia or asplenia.
- Subjects with mental conditions that render them unable to understand the nature, scope, and possible consequences of the study
- Subjects who are unlikely to comply with the protocol (eg, have an uncooperative attitude, an inability to return for follow-up visits, or are unlikely to complete the study)
- Subjects who have known impaired hepatic function
- Subjects who have known impaired renal function
- AECB-Specific
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
2051 Patients enrolled
Trial Details
Trial ID
NCT00132951
Start Date
October 1 2004
End Date
September 1 2006
Last Update
August 27 2009
Active Locations (2)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
2
Sanofi-Aventis Administrative Office
Québec, Canada