Zithromax EV in Community-Acquired Pneumonia (CAP)

NCT00137007 | Completed Phase 4

• 1 other identifier: A0661082
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Interventions

Azithromycin DRUG

Ampicillin/sulbactam DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Pneumonia

Interventions

Azithromycin; sultamicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: November 1, 2003
• Study Completion: September 1, 2005
• Last Updated: April 22, 2011

Record last verified: 2011-04