Zithromax EV in Community-Acquired Pneumonia (CAP)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137007
First received: August 25, 2005
Last updated: April 20, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Pneumonia
Drug: Azithromycin
Drug: Ampicillin/sulbactam
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Enrollment: 151
Study Start Date: November 2003
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137007

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00137007     History of Changes
Other Study ID Numbers: A0661082
Study First Received: August 25, 2005
Last Updated: April 20, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ampicillin
Sulbactam
Azithromycin
Sultamicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014