Zithromax EV in Community-Acquired Pneumonia (CAP)

NCT ID: NCT00137007

Last Updated: 2011-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2005-09-30

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.

Conditions

Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Azithromycin

Intervention Type: DRUG

Ampicillin/sulbactam

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

A0661082

Identifier Type: -

Identifier Source: org_study_id