PeritonitisPhase 3NCT00657566
SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
A Phase 3 study testing duration of antibiotics in people with Peritonitis, run by University of Virginia at 23 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Peritonitis
- What is being tested?
- duration of antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Sep 2008to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age ≥ 16 at some sites,(≥ 18 at UVA)
- ability to obtain informed consent from the subject or surrogate
- Presence of an intraabdominal infection requiring any duration of hospitalization and managed with open, laparoscopic, or percutaneous intervention.
- A peripheral white blood cell count of > 11,000/mm and/or temperature ≥ 38.0 C with in 24 hours or gastrointestinal dysfunction sufficient to prevent intake of normal diet within 24hrs of initial operative or percutaneous intervention.
- Adequate source control in the opinion of the local investigator and PI. Source control is defined as any procedure that stops the ongoing contamination of the peritoneal cavity and removes the majority of the contaminated intraperitoneal contents to the extent that no further acute interventions are felt to be necessary.
Who cannot join
- age < 16 years at some sites(< 18 at UVA)
- Inability to obtain consent from the patient, parents, or surrogate
- Lack of adequate source control in the opinion of the local investigator or overall PI ( Robert Sawyer)
- High likelihood of death within 72 hours of initial intervention in the opinion of the local investigator or principal investigator
- Lack of any clinical improvement within 72 hours of initial intervention in the opinion of the local investigator or principal investigator.
- Planned relaparotomy
Show all 18Show fewer
- Perforated gastric ulcer or duodenal ulcer treated within 24hours of the onset of symptoms
- Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury
- Non-perforated, non-gangrenous appendicitis or cholecystitis
- Gangrenous appendicitis or peritonitis without confirmatory cultures or with cultures without bacterial or fungal growth
- Ischemic or necrotic intestine without perforation and without positive bacterial or fungal cultures
- Intraabdominal infection associated with active necrotizing pancreatitis
- Primary (spontaneous) bacterial peritonitis
- Intraabdominal infection associated with an indwelling continuous ambulatory peritoneal dialysis catheter.
- Primary skin closure of an open surgical incision in the presence of diffuse, non-localized peritonitis. Laparoscopic port sites ≥ 2cm may be closed
- Pregnancy
- Prior enrollment in this study
- Enrollment in another therapeutic trial
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Univeristy of Michigan
Ann Arbor, Michigan, 48502
Johns Hopkins
Baltimore, Maryland, 21205
Brigham and Womens
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22903
Case Western
Cleveland, Ohio, 44106
University of South Carolina
Columbia, South Carolina
Ohio State University
Columbus, Ohio
Univestity of Kansas
Kansas City, Kansas
Louisville-VA
Louisville, Kentucky, 40121
Louisville-University Hospital
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Maricopa Medical Center-Phoenix
Phoenix, Arizona, 85008
Pittsburgh VA
Pittsburgh, Pennsylvania, 15206
Medical College of Virginia-Virginia Commonwealth University Hospital
Richmond, Virginia, 23298
University of California Davis
Sacramento, California
Universtiy of Texas San Antonio
San Antonio, Texas, 78229
University of California San Diego
San Diego, California
University of California San Francisco
San Francisco, California
University of Washington-Harborview
Seattle, Washington, 98104
University of Washington - University Hospital
Seattle, Washington, 98195
Washington Universtiy
St Louis, Missouri, 63110
Wake Forest University
Winston-Salem, North Carolina
About this study
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.
Read the 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
- Conditions
- Peritonitis
- Being tested
- duration of antibiotics
- Keywords
- intraabdominal, peritonitis, sepsis, duration, antibiotics
- Medical subject headings
- Peritonitis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duration of antibioticsOther
Also called short course
4 +/- 1 days of antibiotics
duration of antibioticsOther
Also called long course
active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function Receives: Other: duration of antibiotics |
| 2 | Experimental | 4 +/- 1 days of antibiotics Receives: Other: duration of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis).
Measured: 30 days
Secondary outcomes (10)
Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics
Measured: 30 days
failure rate for microbiologically evaluable patients
Measured: 30 days
rate of need for reintervention in the abdomen
Measured: 30 days
rate of surgical site infection
Measured: 30 days
rate of death within 30 days
Measured: 30 days
duration of hospitalization
Measured: 30 days
rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens
Measured: 30 days
rate of any subsequent infection at a site other than the abdomen or the surgical site
Measured: 30 days
rate of infection at a non-abdominal, non-surgical site with a resistant organism
Measured: 30 days
rate of Clostridium difficile infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Robert Sawyer, MD, National Institute of General Medical Sciences (NIGMS)
- Investigators
- Robert G Sawyer, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657566
- Sponsor's protocol ID
- 13447
- Other IDs
- 1R01GM081510-01
- Status last verified
- May 2018
- First submitted
- 10 Apr 2008
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17083308Sawyer 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.
PubMed 25992746
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
- ClinicalTrials.gov ID
- NCT00657566
- Acronym / sponsor ID
- 13447
- Conditions
- Peritonitis
- Keywords
- intraabdominal, peritonitis, sepsis, duration, antibiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Sep 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: duration of antibioticsantibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function |
| 2 | Experimental | Other: duration of antibiotics4 +/- 1 days of antibiotics |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 16 at some sites,(≥ 18 at UVA)
- ability to obtain informed consent from the subject or surrogate
- Presence of an intraabdominal infection requiring any duration of hospitalization and managed with open, laparoscopic, or percutaneous intervention.
- A peripheral white blood cell count of > 11,000/mm and/or temperature ≥ 38.0 C with in 24 hours or gastrointestinal dysfunction sufficient to prevent intake of normal diet within 24hrs of initial operative or percutaneous intervention.
- Adequate source control in the opinion of the local investigator and PI. Source control is defined as any procedure that stops the ongoing contamination of the peritoneal cavity and removes the majority of the contaminated intraperitoneal contents to the extent that no further acute interventions are felt to be necessary.
Key exclusion criteria (18 listed)
- age < 16 years at some sites(< 18 at UVA)
- Inability to obtain consent from the patient, parents, or surrogate
- Lack of adequate source control in the opinion of the local investigator or overall PI ( Robert Sawyer)
- High likelihood of death within 72 hours of initial intervention in the opinion of the local investigator or principal investigator
- Lack of any clinical improvement within 72 hours of initial intervention in the opinion of the local investigator or principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duration of antibioticsAlso: short course4 +/- 1 days of antibiotics | Other | 2 |
| duration of antibioticsAlso: long courseactive comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction. | Other | 1 |
Primary outcome
The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis).
Time frame: 30 days
10 secondary outcomes
Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics
Time frame: 30 days
failure rate for microbiologically evaluable patients
Time frame: 30 days
rate of need for reintervention in the abdomen
Time frame: 30 days
rate of surgical site infection
Time frame: 30 days
rate of death within 30 days
Time frame: 30 days
duration of hospitalization
Time frame: 30 days
rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens
Time frame: 30 days
rate of any subsequent infection at a site other than the abdomen or the surgical site
Time frame: 30 days
rate of infection at a non-abdominal, non-surgical site with a resistant organism
Time frame: 30 days
rate of Clostridium difficile infection
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Background: PubMed 17083308Hedrick 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.
- Derived from this study: PubMed 25992746Sawyer 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert G Sawyer, MD principal investigator
University of Virginia
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing duration of antibiotics in people with Peritonitis, run by University of Virginia at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00657566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.