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

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ClinicalTrials.gov Identifier: NCT01784770
Recruitment Status : Completed
First Posted : February 6, 2013
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 4, 2013
First Posted Date February 6, 2013
Results First Submitted Date July 6, 2017
Results First Posted Date November 30, 2017
Last Update Posted Date November 30, 2017
Actual Study Start Date March 27, 2013
Actual Primary Completion Date July 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2017)
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.
Original Primary Outcome Measures
 (submitted: February 4, 2013)
Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 29 days ]
Change History Complete list of historical versions of study NCT01784770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 6, 2017)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)
Official Title Zithromac Iv Special Investigation For Legionella Infection.
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A0661208 prescribes the Zithromac IV.
Condition
  • Legionnaires' Disease
  • Legionella Pneumophila Infections
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.

Other Name: Zithromac IV
Study Groups/Cohorts Azithromycin IV
Subjects who are treated with Azithromycin IV for Legionnaires' disease
Intervention: Drug: Azithromycin IV
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 Completed
Actual Enrollment
 (submitted: February 23, 2017)
21
Original Estimated Enrollment
 (submitted: February 4, 2013)
20
Actual Study Completion Date July 29, 2016
Actual Primary Completion Date July 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have been prescribed Zithromac or Zithromac SR.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01784770
Other Study ID Numbers A0661208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2017