Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)

Legionnaires' Disease Clinical Trial

— RESCUE-L  

Official title:

Zithromac Iv Special Investigation For Legionella Infection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784770
• Other study ID #: A0661208
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: July 6, 2017
• Start date: March 27, 2013
• Est. completion date: July 29, 2016

Study information

• Verified date: July 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 29, 2016
• Est. primary completion date: July 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who are prescribed Azithromycin (Zithromac) IV for Legionnaires' disease.

Exclusion Criteria:

• Patients who have been prescribed Zithromac or Zithromac SR.

Related Conditions & MeSH terms

• Infection
• Legionella Pneumophila Infections
• Legionellosis
• Legionnaires' Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events	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.	29 days
Secondary	Clinical Effectiveness Rate in Participants	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.	29 days

External Links

•   To obtain contact information for a study center near you, click here.