The IV regimen containing Azithromycin 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 allows 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 to evaluate the safety and toleration of combination therapy.

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

Further Study Details: 

Primary Outcomes: 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
Secondary Outcomes: 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.
Expected Total Enrollment:  150

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subject 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 condition that would interfere with the evaluation of the therapeutic response or safety of the study drug, including:
• Known Acquired Immunodeficiencey 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; 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00137007

Pfizer CT.gov Call Center      1-800-718-1021 

Italy
      Pfizer Investigational Site, Crema,  26013,  Italy; Recruiting
      Pfizer Investigational Site, Monza (MI),  20052,  Italy; Recruiting
      Pfizer Investigational Site, SONDALO (SO),  23039,  Italy; Recruiting
      Pfizer Investigational Site, Alessandria,  Italy; Recruiting
      Pfizer Investigational Site, Grosseto,  58100,  Italy; Recruiting
      Pfizer Investigational Site, Napoli,  Italy; Recruiting
      Pfizer Investigational Site, Chieti,  Italy; Recruiting
      Pfizer Investigational Site, Bari,  70124,  Italy; Recruiting
      Pfizer Investigational Site, Perugia,  I-06132,  Italy; Recruiting
      Pfizer Investigational Site, Foggia,  I-71100,  Italy; Recruiting
      Pfizer Investigational Site, Bassano del Grappa (VI),  36061,  Italy; Recruiting
      Pfizer Investigational Site, Valdagno (VI),  36078,  Italy; Recruiting
      Pfizer Investigational Site, NARNI - TERNI,  05035,  Italy; Recruiting
      Pfizer Investigational Site, Ferrara,  44100,  Italy; Recruiting
      Pfizer Investigational Site, Palermo,  90127,  Italy; Recruiting
      Pfizer Investigational Site, Palermo,  90146,  Italy; Recruiting
      Pfizer Investigational Site, Sassari,  07100,  Italy; Recruiting
Italy, PERUGIA
      Pfizer Investigational Site, Gubbio,  PERUGIA,  Italy; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A0661082
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00137007
Health Authority: Italy: Ministry of Health
ClinicalTrials.gov processed this record on 2005-08-30