ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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.
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Descriptive Information | ||||
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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 |
| |||
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 | 151 | |||
Original Enrollment ICMJE | 150 | |||
Actual Study Completion Date ICMJE | September 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |