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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01GM081510-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The major hypothesis to be tested is that the treatment of intraabdominal infections that have been adequately treated operatively or by percutaneous techniques with three to five days of antibiotics will result in outcomes equivalent to the current standard where treatment is carried out until the patient has returned to normal (normal white blood cell count, temperature, and intestinal function), and that patients treated for three to five days will receive fewer days of antibiotics than the control group that has traditionally received seven to 14 days of treatment.
Overall, this is a prospective, randomized, single-blinded (analysis), fifteen-center study using intent to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive antibiotics for 3 to 5 days (4 ± 1 days) after the initial surgical or percutaneous intervention or antibiotics until two calendar days after the patient's white blood cell count, systemic temperature, and gastrointestinal function have normalized (maximum of 10 days). The primary endpoint is the composite rate of in-hospital death and/or recurrence of intraabdominal infection and/or occurrence of surgical site (wound) infection. Secondary endpoints include the occurrence of any infection at any site and infection with antibiotic-resistant pathogens. Patient data through the thirty days following the initial intervention or until hospital discharge (whichever is longer) will be tracked
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function |
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| 2 | Experimental | 4 +/- 1 days of antibiotics |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duration of antibiotics | Other | 4 +/- 1 days of antibiotics |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics | 30 days | |
| failure rate for microbiologically evaluable patients | 30 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert G Sawyer, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center-Phoenix | Phoenix | Arizona | 85008 | United States | ||
| University of California Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17083308 | Background | Hedrick TL, Evans HL, Smith RL, McElearney ST, Schulman AS, Chong TW, Pruett TL, Sawyer RG. Can we define the ideal duration of antibiotic therapy? Surg Infect (Larchmt). 2006 Oct;7(5):419-32. doi: 10.1089/sur.2006.7.419. | |
| 25992746 | Derived | Sawyer RG, Claridge JA, Nathens AB, Rotstein OD, Duane TM, Evans HL, Cook CH, O'Neill PJ, Mazuski JE, Askari R, Wilson MA, Napolitano LM, Namias N, Miller PR, Dellinger EP, Watson CM, Coimbra R, Dent DL, Lowry SF, Cocanour CS, West MA, Banton KL, Cheadle WG, Lipsett PA, Guidry CA, Popovsky K; STOP-IT Trial Investigators. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015 May 21;372(21):1996-2005. doi: 10.1056/NEJMoa1411162. |
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| duration of antibiotics | Other | active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction. |
|
|
| rate of need for reintervention in the abdomen |
| 30 days |
| rate of surgical site infection | 30 days |
| rate of death within 30 days | 30 days |
| duration of hospitalization | 30 days |
| rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens | 30 days |
| rate of any subsequent infection at a site other than the abdomen or the surgical site | 30 days |
| rate of infection at a non-abdominal, non-surgical site with a resistant organism | 30 days |
| rate of Clostridium difficile infection | 30 days |
| Sacramento |
| California |
| United States |
| University of California San Diego | San Diego | California | United States |
| University of California San Francisco | San Francisco | California | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Univestity of Kansas | Kansas City | Kansas | United States |
| Louisville-VA | Louisville | Kentucky | 40121 | United States |
| Louisville-University Hospital | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Brigham and Womens | Boston | Massachusetts | 02115 | United States |
| Univeristy of Michigan | Ann Arbor | Michigan | 48502 | United States |
| Washington Universtiy | St Louis | Missouri | 63110 | United States |
| Wake Forest University | Winston-Salem | North Carolina | United States |
| Case Western | Cleveland | Ohio | 44106 | United States |
| Ohio State University | Columbus | Ohio | United States |
| Pittsburgh VA | Pittsburgh | Pennsylvania | 15206 | United States |
| University of South Carolina | Columbia | South Carolina | United States |
| Universtiy of Texas San Antonio | San Antonio | Texas | 78229 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Medical College of Virginia-Virginia Commonwealth University Hospital | Richmond | Virginia | 23298 | United States |
| University of Washington-Harborview | Seattle | Washington | 98104 | United States |
| University of Washington - University Hospital | Seattle | Washington | 98195 | United States |
| St Michael's | Toronto | Ontario | Canada |
| ID | Term |
|---|---|
| D010538 | Peritonitis |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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