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Zithromax EV in Community-Acquired Pneumonia (CAP)

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ClinicalTrials.gov Identifier: NCT00137007
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date April 22, 2011
Study Start Date  ICMJE November 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
To evaluate the clinical efficacy of Intravenous (IV) Azithromycin 500 mg once daily plus IV Ampicillin/sulbactam 3 gram BID for 2 to 5 days followed by oral Azithromycin 500 mg once daily plus IV Ampicillin/sulbactam 3 gram BID to complete a total of
Change History Complete list of historical versions of study NCT00137007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2005)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
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 an Visit 4.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zithromax EV in Community-Acquired Pneumonia (CAP)
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • Drug: Azithromycin
  • Drug: Ampicillin/sulbactam
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2011)
151
Original Enrollment  ICMJE
 (submitted: August 25, 2005)
150
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT00137007
Other Study ID Numbers  ICMJE A0661082
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP