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Zithromax EV in Community-Acquired Pneumonia (CAP)

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Azithromycin
Ampicillin/sulbactam
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

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

Inclusion Criteria: Subjects must require hospitalization and intravenous therapy. Subjects must have a Fine pneumonia score > 70 (Fine Class > II). Subjects must have a medical history and clinical and radiological findings consistent with a community-acquired bronchopneumonia or lobar pneumonia. The following criteria must be met: new infiltrate(s) on chest X-ray; AND at least two of the CAP signs or symptoms. Exclusion Criteria: Treatment with any systemic antibiotic for 24 hours or longer within 72 hours of the baseline visit, or treatment for more than 7 days within 15 days. Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug, including: Known acquired immunodeficiency syndrome (AIDS) or suspected Pneumocystis carinii pneumonia; Neutropenia; Cavitary lung disease by chest X-ray; Primary lung cancer or other malignancy metastatic to the lung; Aspiration pneumonia; Empyema; Known or suspected tuberculosis; Neoplastic disease; Cystic fibrosis; A history of any form of epilepsy or seizure; DDM; Bronchiectasis, bronchial obstruction or history of post-obstructive pneumonia (this does not exclude patients with chronic obstructive pulmonary disease); Significant gastrointestinal or other conditions which may affect study drug absorption; and Significant cardiovascular disorders. Immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications Impaired hepatic function, as shown by, but not limited to, AST, (SGOT), or ALT (SGPT) greater than three times the laboratory upper limit of normal, or total bilirubin greater than two times the upper limit of normal. Subjects already hospitalized or who resided in a long-term-care facility for greater than 14 days before the onset of symptoms.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To evaluate the clinical efficacy of intravenous (IV) azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams twice a day (BID) for 2 to 5 days
    followed by oral azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams.

    Secondary Outcome Measures

    To evaluate the eradication of baseline pathogens of IV azithromycin plus IV ampicillin/sulbactam followed by oral azithromycin plus IV ampicillin/sulbactam at Visit 3 and Visit 4

    Full Information

    First Posted
    August 25, 2005
    Last Updated
    April 20, 2011
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00137007
    Brief Title
    Zithromax EV in Community-Acquired Pneumonia (CAP)
    Official Title
    A Multicenter, Open Label Trial Evaluating Intravenous Azithromycin Plus Intravenous Ampicillin/Sulbactam Followed by Oral Azithromycin Plus Intravenous Ampicillin/Sulbactam for the Treatment of Hospitalized Subjects With Community-Acquired Pneumonia (CAP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide. This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    151 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin
    Intervention Type
    Drug
    Intervention Name(s)
    Ampicillin/sulbactam
    Primary Outcome Measure Information:
    Title
    To evaluate the clinical efficacy of intravenous (IV) azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams twice a day (BID) for 2 to 5 days
    Title
    followed by oral azithromycin 500 mg once daily plus IV ampicillin/sulbactam 3 grams.
    Secondary Outcome Measure Information:
    Title
    To evaluate the eradication of baseline pathogens of IV azithromycin plus IV ampicillin/sulbactam followed by oral azithromycin plus IV ampicillin/sulbactam at Visit 3 and Visit 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must require hospitalization and intravenous therapy. Subjects must have a Fine pneumonia score > 70 (Fine Class > II). Subjects must have a medical history and clinical and radiological findings consistent with a community-acquired bronchopneumonia or lobar pneumonia. The following criteria must be met: new infiltrate(s) on chest X-ray; AND at least two of the CAP signs or symptoms. Exclusion Criteria: Treatment with any systemic antibiotic for 24 hours or longer within 72 hours of the baseline visit, or treatment for more than 7 days within 15 days. Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug, including: Known acquired immunodeficiency syndrome (AIDS) or suspected Pneumocystis carinii pneumonia; Neutropenia; Cavitary lung disease by chest X-ray; Primary lung cancer or other malignancy metastatic to the lung; Aspiration pneumonia; Empyema; Known or suspected tuberculosis; Neoplastic disease; Cystic fibrosis; A history of any form of epilepsy or seizure; DDM; Bronchiectasis, bronchial obstruction or history of post-obstructive pneumonia (this does not exclude patients with chronic obstructive pulmonary disease); Significant gastrointestinal or other conditions which may affect study drug absorption; and Significant cardiovascular disorders. Immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications Impaired hepatic function, as shown by, but not limited to, AST, (SGOT), or ALT (SGPT) greater than three times the laboratory upper limit of normal, or total bilirubin greater than two times the upper limit of normal. Subjects already hospitalized or who resided in a long-term-care facility for greater than 14 days before the onset of symptoms.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Zithromax EV in Community-Acquired Pneumonia (CAP)

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