Outpatient Registry Trial of Respiratory Tract Infections in Adults

July 27, 2015 updated by: CPL Associates

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

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

Study Overview

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kentucky
      • Louisville, Kentucky, United States, 42240
        • Western Kentucky Pulmonary Clinic
    • Louisiana
      • Slidell, Louisiana, United States, 70461
        • Northshore Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Jerome J Schentag, Pharm.D., State University of New York at Buffalo
  • Study Director: Joseph Paladino, Pharm.D., State University of New York at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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