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

NCT00132951 | Terminated Phase 4

• 1 other identifier: HMR3647A_4019
• Study Type: interventional
• Target: 2,051
• Locations: 2 countries
• Sites: 2

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.

Conditions

Respiratory Tract Infections; Chronic Bronchitis; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Telithromycin DRUG

Telithromycin (AECB: 2 tablets per day for Days 1-5; CAP: 2 tablets per day for Days 1-7)

Also known as: Ketek

Azithromycin DRUG

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)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• 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
• 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

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Location

Sanofi-Aventis Administrative Office

Québec, Canada

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Bronchitis, Chronic; Pneumonia

Interventions

telithromycin; Azithromycin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Phyllis Diener, BS, MT (ASCP)

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: October 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: August 27, 2009

Record last verified: 2009-08

Locations

US (1); CA (1)