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To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis
Appendicitis is the most common cause of abdominal pain requiring emergent surgical intervention in children and approximately one third of patients present with perforation. Perforated appendicitis has been demonstrated to have a significant impact on patients and families due to the prolonged hospitalization, high complication rates, and tremendous economic burden from treatment. The most significant complication following operative treatment of perforated appendicitis is intra-abdominal abscess, which develops in approximately 20% of children following appendectomy in recent literature. Due to this frequent and morbid complication, continued research has been driven at determining the most efficacious and cost-effective postoperative antibiotic treatment regimen to reduce post-operative abscess. As postoperative abscess rates following appendectomy for perforated appendicitis remain high, the primary aim of this study was to evaluate a new postoperative antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with randomization into ten day completion course of home antibiotics with IV ertapenem versus oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer reduced rates of postoperative abscess, with no major difference between completion courses of home IV versus oral antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| home intravenous ertapenem and PICC | Active Comparator | Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class:carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily) |
|
| home oral amoxicillin-clavulanate | Experimental | Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate(Drug Class:beta lactam antibiotic)(15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home intravenous ertapenem | Drug | see arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Abscess | Number of Postoperative Abscess, thirty-day postoperative | Thirty days after appendectomy |
| Number of Participants With Wound Infections | Number of Wound Infections, 30-days postoperative | Thirty days following appendectomy |
| Number Participants With Readmission Within 30 Days | Number of Readmission within 30 days postoperative | Thirty days following appendectomy |
| Hospital Charge | Cost of Hospital services | Thirty days following appendectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brant T Heniford, M.D. | Wake Forest University Health Sciences | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Intravenous Ertapenem and PICC | Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily) Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics. |
| FG001 | Home Oral Amoxicillin-clavulanate | Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home Intravenous Ertapenem and PICC | Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily) Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Postoperative Abscess | Number of Postoperative Abscess, thirty-day postoperative | Posted | Count of Participants | Participants | Thirty days after appendectomy |
|
30 days
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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 | Home Intravenous Ertapenem and PICC | Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class: carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily) Peripheral inserted central Catheter: All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adinamic ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. B. Todd Heniford | Atrium Health | 704-355-3168 | Todd.Heniford@atriumhealth.org |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| home oral amoxicillin-clavulanate | Drug | see arm description |
|
|
| peripheral inserted central Catheter | Device | All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics. |
|
|
| BG001 | Home Oral Amoxicillin-clavulanate | Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours). |
|
|
|
| Primary | Number of Participants With Wound Infections | Number of Wound Infections, 30-days postoperative | Posted | Count of Participants | Participants | Thirty days following appendectomy |
|
|
|
|
| Primary | Number Participants With Readmission Within 30 Days | Number of Readmission within 30 days postoperative | Posted | Count of Participants | Participants | Thirty days following appendectomy |
|
|
|
|
| Primary | Hospital Charge | Cost of Hospital services | Posted | Mean | Standard Deviation | Dollars | Thirty days following appendectomy |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Home Oral Amoxicillin-clavulanate | Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate (Drug Class: beta lactam antibiotic) (15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours). | 0 | 38 | 2 | 38 | 0 | 38 |
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |