Zithromax EV in Community-Acquired Pneumonia (CAP)
|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|
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137007
|Study Director:||Pfizer CT.gov Call Center||Pfizer|