Outpatient Registry Trial of Respiratory Tract Infections in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-07-31

Brief Summary

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

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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

Conditions

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Pneumonia, Bacterial Bronchitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Azithromycin

Group Type ACTIVE_COMPARATOR

azithromycin

Intervention Type DRUG

250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5

2 Clarythromycin

Group Type ACTIVE_COMPARATOR

Clarythromycin

Intervention Type DRUG

500 mg extended release tablets; 2 tablets QD for 7 days

3 Telithromycin

Group Type ACTIVE_COMPARATOR

telithromycin

Intervention Type DRUG

400 mg tablets; 2 tablets once daily (QD) for 5 days

Interventions

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azithromycin

250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5

Intervention Type DRUG

telithromycin

400 mg tablets; 2 tablets once daily (QD) for 5 days

Intervention Type DRUG

Clarythromycin

500 mg extended release tablets; 2 tablets QD for 7 days

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No