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To collect the efficacy and safety information of Azithromycin IV 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 |
|
| 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 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 (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. | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Effectiveness Rate in Participants With Pneumonia | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involviong A0661207 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 401 participants completed this study. Of the 401 participants, 1 participant was excluded from the baseline analysis due to 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 (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. | 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 |
|---|---|---|---|---|---|
| Clostridium difficile colitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA 18.1 | 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 |
|---|---|
| D011014 | Pneumonia |
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
|
| 29 days |
| Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease | 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. | 29 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Disease Type | * indicates comorbidities tabulated in duplicate. | Number | 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 With Pneumonia | 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. | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of pneumonia (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 |
|
|
|
| Secondary | Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease | 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. | The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of PID (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 |
|
|
|
| 43 |
| 400 |
| 34 |
| 400 |
| Gastroenteritis staphylococcal | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Abortion complete | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
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.
| D034161 |
| Pelvic Infection |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |