Status:
WITHDRAWN
Outpatient Registry Trial of Respiratory Tract Infections in Adults
Lead Sponsor:
CPL Associates
Collaborating Sponsors:
Sanofi
Conditions:
Pneumonia, Bacterial
Bronchitis, Chronic
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.
Detailed Description
To Evaluate the relationship between rate of S. pneumoniae killing in sputum, PK/PD, and clinical response of oral telithromycin and azithromycin in patients with AECB or CAP and to determine if there...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00245453
Start Date
October 1 2005
End Date
July 1 2006
Last Update
July 28 2015
Active Locations (2)
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1
Western Kentucky Pulmonary Clinic
Louisville, Kentucky, United States, 42240
2
Northshore Research Associates
Slidell, Louisiana, United States, 70461