KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Respiratory Tract Infections, Chronic Bronchitis, Pneumonia

In brief

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.

Key facts

Study ID

NCT00132951

Run by

Sanofi

People needed

2051

Starts

2004-10-01

Expected to finish

2006-09-01

Last updated by the study team

2009-08-27

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 Exclusion Criteria:
• Subjects with acute bronchitis
• Subjects with a known diagnosis of bronchiectasis; cystic fibrosis; lung cancer or lung metastases; or active pulmonary tuberculosis.
• CAP-Specific Exclusion Criteria:

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Québec, Canada

Full record on ClinicalTrials.gov

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