Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan) (RESCUE-L)
|ClinicalTrials.gov Identifier: NCT01784770|
Recruitment Status : Completed
First Posted : February 6, 2013
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment|
|Legionnaires' Disease Legionella Pneumophila Infections||Drug: Azithromycin IV|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||Zithromac Iv Special Investigation For Legionella Infection.|
|Actual Study Start Date :||March 27, 2013|
|Primary Completion Date :||July 29, 2016|
|Study Completion Date :||July 29, 2016|
Subjects who are treated with Azithromycin IV for Legionnaires' disease
Drug: Azithromycin IV
The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.
The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.
Other Name: Zithromac IV
- Number of Participants With Treatment-Related Adverse Events [ Time Frame: 29 days ]A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.
- Clinical Effectiveness Rate in Participants [ Time Frame: 29 days ]Clinical effectiveness rate in participants, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784770
|Study Director:||Pfizer CT.gov Call Center||Pfizer|