An observational study in Legionnaires' Disease and Legionella Pneumophila Infections, sponsored by Pfizer. Completed. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by Pfizer · Observational
To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
The patients whom an investigator involving A0661208 prescribes the Zithromac IV.
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Exclusion Criteria:
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.
Also known as: Zithromac IV
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.
Time frame: 29 days
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.
Time frame: 29 days
| Milestone | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
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.
| Participants | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| Treatment-Related Adverse Event | 2 |
| Treatment-Related Serious Adverse Event | 0 |
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.
| Percentage of Participants | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| Clinical Effectiveness Rate in Participants | 95.2 (76.18 to 99.88) |
Non-serious events are listed at a 1.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zithromac Intravenous Use (Azithromycin Hydrate) | — | 1/21 (4.8%) | 7/21 (33.3%) |
| Event | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/21 |
| Event | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| BradycardiaCardiac disorders | 1/21 |
| Hepatic function abnormalHepatobiliary disorders | 1/21 |
| Liver disorderHepatobiliary disorders | 1/21 |
| Toxic skin eruptionSkin and subcutaneous tissue disorders | 1/21 |
| Chondrocalcinosis pyrophosphateMusculoskeletal and connective tissue disorders | 1/21 |
| CrystalluriaRenal and urinary disorders | 1/21 |
| PollakiuriaRenal and urinary disorders | 1/21 |
A total of 21 participants completed this study. There is no protocol violation.
| Age, Customized(Participants) | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| <15 years | 0 |
| ≥15 and <65 years | 14 |
| ≥65 years | 7 |
| Sex: Female, Male(Participants) | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| Female | 4 |
| Male | 17 |
No study locations are listed for this record.
Ran from Mar 2013 to primary completion in Jul 2016, 40 months.
Results were first posted in Nov 2017, 1 year 4 months after primary completion.
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Legionnaires' Disease