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| Descriptive Information Fields | |||||||||
| Brief Title † | SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection | ||||||||
| Official Title † | SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics [ Time Frame: 30 days ] [ Designated as safety issue: No ] failure rate for microbiologically evaluable patients [ Time Frame: 30 days ] [ Designated as safety issue: No ] rate of need for reintervention in the abdomen [ Time Frame: 30 days ] [ Designated as safety issue: No ] rate of surgical site infection [ Time Frame: 30 days ] [ Designated as safety issue: No ] rate of death within 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ] duration of hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ] rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens [ Time Frame: 30 days ] [ Designated as safety issue: No ] rate of any subsequent infection at a site other than the abdomen or the surgical site [ Time Frame: 30 days ] [ Designated as safety issue: No ] rate of infection at a non-abdominal, non-surgical site with a resistant organism [ Time Frame: 30 days ] [ Designated as safety issue: No ] rate of Clostridium difficile infection [ Time Frame: 30 days ] [ Designated as safety issue: No ] |
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| Condition † | Peritonitis | ||||||||
| Intervention † | Other: duration of antibiotics | ||||||||
| MEDLINE PMIDs | 17083308 | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 1150 | ||||||||
| Start Date † | September 2008 | ||||||||
| Completion Date | September 2012 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States, Canada | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00657566 | ||||||||
| Organization ID | 13447 | ||||||||
| Secondary IDs †† | 1R01GM081510-01 | ||||||||
| Study Sponsor † | National Institute of General Medical Sciences (NIGMS) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of General Medical Sciences (NIGMS) | ||||||||
| Verification Date | September 2008 | ||||||||
| First Received Date † | April 10, 2008 | ||||||||
| Last Updated Date | September 23, 2008 | ||||||||