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Outpatient Registry Trial of Respiratory Tract Infections in Adults

Primary Purpose

Pneumonia, Bacterial, Bronchitis, Chronic

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
azithromycin
telithromycin
Clarythromycin
Sponsored by
CPL Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Bacterial focused on measuring pneumonia, Spneumoniae, bronchitis, telithromycin, azithromycin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Kentucky Pulmonary Clinic
  • Northshore Research Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1 Azithromycin

2 Clarythromycin

3 Telithromycin

Arm Description

Outcomes

Primary Outcome Measures

Time to bacterial eradication
Bacteriologic outcome

Secondary Outcome Measures

Full Information

First Posted
October 26, 2005
Last Updated
July 27, 2015
Sponsor
CPL Associates
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00245453
Brief Title
Outpatient Registry Trial of Respiratory Tract Infections in Adults
Official Title
Randomized Aseptic Pharmacokinetic Pharmacodynamic Outpatient Registry Trial of Respiratory Tract Infections in Adults (RAPPORT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Terminated by sponsor
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CPL Associates
Collaborators
Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial, Bronchitis, Chronic
Keywords
pneumonia, Spneumoniae, bronchitis, telithromycin, azithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Azithromycin
Arm Type
Active Comparator
Arm Title
2 Clarythromycin
Arm Type
Active Comparator
Arm Title
3 Telithromycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
azithromycin
Intervention Description
250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5
Intervention Type
Drug
Intervention Name(s)
telithromycin
Intervention Description
400 mg tablets; 2 tablets once daily (QD) for 5 days
Intervention Type
Drug
Intervention Name(s)
Clarythromycin
Intervention Description
500 mg extended release tablets; 2 tablets QD for 7 days
Primary Outcome Measure Information:
Title
Time to bacterial eradication
Time Frame
11-18 days
Title
Bacteriologic outcome
Time Frame
11-18 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome J Schentag, Pharm.D.
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Paladino, Pharm.D.
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Study Director
Facility Information:
Facility Name
Western Kentucky Pulmonary Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
42240
Country
United States
Facility Name
Northshore Research Associates
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cplassociates.com
Description
Related Info

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Outpatient Registry Trial of Respiratory Tract Infections in Adults

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