Outpatient Registry Trial of Respiratory Tract Infections in Adults

Phase 4

Withdrawn

• Conditions: Pneumonia, Bacterial; Bronchitis, Chronic
• Interventions: Drug: azithromycin; Drug: Clarythromycin; Drug: telithromycin

• Registration Number: NCT00245453
• Lead Sponsor: CPL Associates

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 is a difference in the rates of infection site bacterial killing (as described above) between these 3 antibiotics against penicillin- and erythromycin-resistant S.pneumoniae

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Study Completion: 2006-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Azithromycin	azithromycin	-
2 Clarythromycin	Clarythromycin	-
3 Telithromycin	telithromycin	-

Primary Outcome Measures

Name	Time	Method
Time to bacterial eradication	11-18 days
Bacteriologic outcome	11-18 days

Trial Locations

Locations (2)

Western Kentucky Pulmonary Clinic; 🇺🇸 Louisville, Kentucky, United States

Northshore Research Associates; 🇺🇸 Slidell, Louisiana, United States