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PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.
Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 minutes | 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. |
| |
| 30 minutes | 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. |
| |
| 60 minutes | 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 500 mg intravenous infused over 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration | The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections. | 48 hours after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women 19 years and older undergoing scheduled cesearean sections
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| Name | Affiliation | Role |
|---|---|---|
| Amelia L Sutton, M.D., Ph.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
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Patients were recruited from the prenatal clinic from May 2012 to May 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 15 Minutes | 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
| FG001 | 30 Minutes | 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
| FG002 | 60 Minutes | 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 15 Minutes | 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
| BG001 | 30 Minutes | 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Patients in Each Group That Attain an Adequate Azithromycin Concentration | The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections. | No patients had azithromycin concentrations at least equivalent to the MIC 90. | Posted | Number | number of participants | 48 hours after delivery |
|
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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 | 15 Minutes | 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amelia Sutton, M.D., Ph.D. | University of Alabama at Birmingham | 205-934-5612 | alsutton@uab.edu |
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| ID | Term |
|---|---|
| D004716 | Endometritis |
| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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Maternal blood, maternal adipose tissue, maternal myometrium, maternal breast milk, amniotic fluid, and fetal cord blood.
| BG002 | 60 Minutes | 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour
| OG002 | 60 Minutes | 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 30 Minutes | 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour | 0 | 10 | 0 | 10 |
| EG002 | 60 Minutes | 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. Azithromycin : 500 mg intravenous infused over 1 hour | 0 | 10 | 0 | 10 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |
| Organic Chemicals |