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To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin IV | Subjects who are treated with Azithromycin IV for Legionnaires' disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin IV | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A0661208 prescribes the Zithromac IV.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zithromac Intravenous Use (Azithromycin Hydrate) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 21 participants completed this study. There is no protocol violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zithromac Intravenous Use (Azithromycin Hydrate) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once. | Posted | Number | Participants | 29 days |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zithromac Intravenous Use (Azithromycin Hydrate) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D007877 | Legionnaires' Disease |
| ID | Term |
|---|---|
| D007876 | Legionellosis |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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|
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| 29 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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.
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 29 days |
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|
|
| 1 |
| 21 |
| 7 |
| 21 |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Crystalluria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
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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.
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |