Pelvic Inflammatory Disease, Pneumonia
Conditions
Keywords
pneumonia, pelvic inflammatory disease, Zithromax, Zithromac, Japanese, Regulatory Post Marketing Commitment Plan
Brief summary
To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice
Interventions
DRUGAzithromycin 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.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Effectiveness Rate in Participants With Pneumonia | 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 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 400 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Zithromac Intravenous Use (Azithromycin Hydrate) |
|---|---|
| Age, Customized ≥15 and <65 years | 191 Participants |
| Age, Customized <15 years | 1 Participants |
| Age, Customized ≥65 years | 208 Participants |
| Disease Type Other* | 6 participants |
| Disease Type Pelvic inflammatory disease* | 98 participants |
| Disease Type Pneumonia* | 299 participants |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 400 |
| serious Total, serious adverse events | 43 / 400 |
Outcome results
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.
Time frame: 29 days
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zithromac Intravenous Use (Azithromycin Hydrate) | Number of Participants With Treatment-Related Adverse Events | Treatment-Related Adverse Event | 39 Participants |
| Zithromac Intravenous Use (Azithromycin Hydrate) | Number of Participants With Treatment-Related Adverse Events | Treatment-Related Serious Adverse Event | 7 Participants |
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.
Time frame: 29 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zithromac Intravenous Use (Azithromycin Hydrate) | Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease | 91.2 Percentage of Participants |
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.
Time frame: 29 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zithromac Intravenous Use (Azithromycin Hydrate) | Clinical Effectiveness Rate in Participants With Pneumonia | 89.6 Percentage of Participants |