Outpatient Registry Trial of Respiratory Tract Infections... | NCT00245453

Studies
Outpatient Registry Trial of Respiratory Tract Infections in Adults

NCT00245453

Sponsor

CPL Associates

Status

Withdrawn

Last Update Posted

Jul 28, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Pneumonia, Bacterial
Bronchitis, Chronic

Interventions

azithromycin
telithromycin
Clarythromycin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated by sponsor

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Oct 26, 2005

First Submission Date that Met QC Criteria

Oct 26, 2005

First Posted Date

Oct 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 28, 2015Estimated

Name	Class
Sanofi	INDUSTRY

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1 Azithromycin	Active Comparator	Drug: azithromycin
2 Clarythromycin	Active Comparator	Drug: Clarythromycin
3 Telithromycin	Active Comparator	Drug: telithromycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
azithromycin	Drug	250 mg tablets; 2 tablets on day 1 (500 mg load) and 1 tablet QD on days 2-5	1 Azithromycin

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Kentucky Pulmonary Clinic		Louisville	Kentucky	42240	United States
Northshore Research Associates

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012141	Respiratory Tract Infections

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930

ID	Term
D018410	Pneumonia, Bacterial
D029481	Bronchitis, Chronic
D011014	Pneumonia
D001991	Bronchitis