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Trial record 1 of 1 for:    NCT01671280
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Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) (RESCUE)

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ClinicalTrials.gov Identifier: NCT01671280
Recruitment Status : Completed
First Posted : August 23, 2012
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date August 20, 2012
First Posted Date August 23, 2012
Results First Submitted Date March 15, 2017
Results First Posted Date April 26, 2017
Last Update Posted Date April 26, 2017
Actual Study Start Date September 20, 2012
Actual Primary Completion Date April 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 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 (and Zithromac Tablets). 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: August 20, 2012)
Number of Participants with Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: 29 days ]
Change History Complete list of historical versions of study NCT01671280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 15, 2017)
  • Clinical Effectiveness Rate in Participants With Pneumonia [ Time Frame: 29 days ]
    Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, 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.
  • Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease [ Time Frame: 29 days ]
    Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, 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
 (submitted: August 20, 2012)
Number of Participants with Clinical Response of Cure at the Test-of-Cure(TOC) Visit [ Time Frame: 29 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)
Official Title Drug Use Investigation Of Azithromycin Iv
Brief Summary To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involviong A0661207 prescribes the Zithromac IV.
Condition
  • Pneumonia
  • Pelvic Inflammatory Disease
Intervention Drug: Azithromycin IV

The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with 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
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: January 30, 2017)
403
Original Estimated Enrollment
 (submitted: August 20, 2012)
400
Actual Study Completion Date April 22, 2016
Actual Primary Completion Date April 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or Female patients who are prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Exclusion Criteria:

  • Subjects who have been prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.
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 NCT01671280
Other Study ID Numbers A0661207
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 March 2017