Outpatient Registry Trial of Respiratory Tract Infections in Adults

• Status: Withdrawn
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CPL Associates
• Collaborator: Sanofi
• Treatments: Azithromycin; Clarithromycin; Telithromycin

Criteria

Inclusion Criteria:

• Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of CAP or AECB who are amenable to serial nasopharyngeal and oropharyngeal sampling and having positive Binax-NOW tests indicating infection with Streptococcus pneumoniae

• Patients with a medical history and clinical findings consistent with a respiratory tract infection. A patient with advanced COPD, repeated exacerbations by history, a BINAX-NOW test consistent with S. pneumoniae and/or proven culture positivity for S. pneumoniae may be enrolled

• All patients (CAP or AECB) must produce purulent sputum and be positive on the Urinary BINAX-NOW assay.

• The female patient of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or IUD). The patient must agree to continue with the same method throughout the study.

Exclusion Criteria:

• Baseline sputum cultures known to be negative for S. pneumoniae, or negative urinary BINAX-NOW.

• Patients with a microbiologically documented pathogen known prior to inclusion to be resistant to any of the study medications.

• History of hypersensitivity to macrolides, azalides, ketolide antibiotics or history of serious hypersensitivity reaction to any drug.

• Pre-existing impaired hepatic function or impaired renal function CCL <20ml/min

• Patients who will require on-study treatment with medications known to have contraindicated drug interactions with telithromycin

• Treatment with more than one dose of an antimicrobial prior to entry into the study

Others as per protocol