Zithromax EV in Community-Acquired Pneumonia (CAP)
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|ClinicalTrials.gov Identifier: NCT00137007|
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : April 22, 2011
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 or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: Azithromycin Drug: Ampicillin/sulbactam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||November 2003|
|Actual Study Completion Date :||September 2005|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137007
|Study Director:||Pfizer CT.gov Call Center||Pfizer|