Respiratory Tract Infections, Chronic Bronchitis, Pneumonia
Conditions
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 exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.
Interventions
DRUGTelithromycin
Telithromycin (AECB: 2 tablets per day for Days 1-5; CAP: 2 tablets per day for Days 1-7)
DRUGAzithromycin
Azithromycin (AECB: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5; CAP: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5 then 2 placebo tablets per day for Days 6-7)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
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 Inclusion Criteria: * 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 Inclusion Criteria: * 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 criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-treatment utilization of healthcare resources, as assessed by unscheduled nonprotocol return office visits, emergency room (ER) visits, hospitalization, and additional nonprotocol antibiotic prescriptions in the 30 days following treatment. | 18 months |
Countries
Canada, United States
Outcome results
None listed