NCT00245453

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

First QC Date

October 26, 2005

Last Update Submit

July 27, 2015

Conditions

Pneumonia, BacterialBronchitis, Chronic

Keywords

pneumoniaSpneumoniaebronchitistelithromycinazithromycin

Outcome Measures

Primary Outcomes (2)

  • Time to bacterial eradication

    11-18 days

  • Bacteriologic outcome

    11-18 days

Study Arms (3)

1 Azithromycin

ACTIVE COMPARATOR
Drug: azithromycin

2 Clarythromycin

ACTIVE COMPARATOR
Drug: Clarythromycin

3 Telithromycin

ACTIVE COMPARATOR
Drug: telithromycin

Interventions

azithromycinDRUG

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

1 Azithromycin
telithromycinDRUG

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

3 Telithromycin
ClarythromycinDRUG

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

2 Clarythromycin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Baseline sputum cultures known to be negative for S. pneumoniae, or negative urinary BINAX-NOW.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Western Kentucky Pulmonary Clinic

Louisville, Kentucky, 42240, United States

Location

Northshore Research Associates

Slidell, Louisiana, 70461, United States

Location

Related Links

MeSH Terms

Conditions

Pneumonia, BacterialBronchitis, ChronicPneumoniaBronchitis

Interventions

Azithromycintelithromycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructivePulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • 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
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

October 1, 2005

Study Completion

July 1, 2006

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

US(2)