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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.
This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Experimental | Once-a-day dose of IV/IM ertapenem for at least two days and cefdinir and metronidazole, to complete 10 days total antibiotic therapy. |
|
| Appendectomy | Active Comparator | Patients in the surgery therapy arm will only receive one dose of IV ertapenem prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 gm IV ertapenem at enrollment | Drug |
| ||
| 1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major Complications | The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) criteria and definitions for major complications will be used. In addition, antibiotic related complications will be evaluated, i.e., antibiotic-related/Clostridium difficile colitis and antibiotic reaction requiring hospitalization. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent appendicitis | 30 days | |
| QOL outcomes | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olive View-UCLA Medical Center | Sylmar | California | 91342 | United States |
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| Drug |
|
| Appendectomy | Procedure |
|
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D001062 | Appendectomy |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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