Outpatient Registry Trial of Respiratory Tract Infections in Adults

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

Detailed Description
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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

Official Title
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Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)

Conditions
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Pneumonia, Bacterial, Bronchitis, Chronic

Intervention / Treatment
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* Drug: azithromycin
* Drug: telithromycin
* Drug: Clarythromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Azithromycin<br> | Drug: azithromycin<br>* 250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5<br>|
| Active Comparator: 2 Clarythromycin<br> | Drug: Clarythromycin<br>* 500 mg extended release tablets; 2 tablets QD for 7 days<br>|
| Active Comparator: 3 Telithromycin<br> | Drug: telithromycin<br>* 400 mg tablets; 2 tablets once daily (QD) for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to bacterial eradication |  | 11-18 days | 
| Bacteriologic outcome |  | 11-18 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, Spneumoniae, bronchitis, telithromycin, azithromycin