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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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Conditions Legionnaires' Disease
Legionella Pneumophila Infections
Intervention Drug: Azithromycin IV
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zithromac Intravenous Use (Azithromycin Hydrate)
Hide Arm/Group Description Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Zithromac Intravenous Use (Azithromycin Hydrate)
Hide Arm/Group Description Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
A total of 21 participants completed this study. There is no protocol violation.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants
<15 years 0
≥15 and <65 years 14
≥65 years 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
4
  19.0%
Male
17
  81.0%
1.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events
Hide Description 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.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.
Arm/Group Title Zithromac Intravenous Use (Azithromycin Hydrate)
Hide Arm/Group Description:
Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Participants
Treatment-Related Adverse Event 2
Treatment-Related Serious Adverse Event 0
2.Secondary Outcome
Title Clinical Effectiveness Rate in Participants
Hide Description 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.
Time Frame 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.
Arm/Group Title Zithromac Intravenous Use (Azithromycin Hydrate)
Hide Arm/Group Description:
Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
95.2
(76.18 to 99.88)
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Zithromac Intravenous Use (Azithromycin Hydrate)
Hide Arm/Group Description Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
All-Cause Mortality
Zithromac Intravenous Use (Azithromycin Hydrate)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zithromac Intravenous Use (Azithromycin Hydrate)
Affected / at Risk (%)
Total   1/21 (4.76%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage * 1  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Zithromac Intravenous Use (Azithromycin Hydrate)
Affected / at Risk (%)
Total   7/21 (33.33%) 
Cardiac disorders   
Bradycardia * 1  1/21 (4.76%) 
Hepatobiliary disorders   
Hepatic function abnormal * 1  1/21 (4.76%) 
Liver disorder * 1  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Chondrocalcinosis pyrophosphate * 1  1/21 (4.76%) 
Renal and urinary disorders   
Crystalluria * 1  1/21 (4.76%) 
Pollakiuria * 1  1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Toxic skin eruption * 1  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01784770     History of Changes
Other Study ID Numbers: A0661208
First Submitted: February 4, 2013
First Posted: February 6, 2013
Results First Submitted: July 6, 2017
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017