Trial of short-course antimicrobial therapy for intraabdominal infection

doi:10.1056/NEJMoa1411162

Randomized Controlled Trial

. 2015 May 21;372(21):1996-2005.

doi: 10.1056/NEJMoa1411162.

Trial of short-course antimicrobial therapy for intraabdominal infection

Collaborators, Affiliations

Collaborators

STOP-IT Trial Investigators:
Joseph Cuschieri, David C Evans, Charles M Friel, Chinedu Njoku, Stanislaw P Stawicki

Affiliation

¹ From the Department of Surgery, University of Virginia Health System, Charlottesville (R.G.S., C.A.G., K.P.); the Department of Surgery, Virginia Commonwealth University, Richmond (T.M.D.); the Department of Surgery, Case Western Reserve University, Cleveland (J.A.C.); the Department of Surgery, University of Toronto, Toronto (A.B.N., O.D.R.); the Department of Surgery, University of Washington, Seattle (H.L.E., E.P.D.); the Department of Surgery, Beth Israel Deaconess Medical Center (C.H.C.), and the Department of Surgery, Brigham and Women's Hospital (R.A.) - both in Boston; the Department of Surgery, Maricopa Integrated Health System, Phoenix, AZ (P.J.O.); the Department of Surgery, Washington University, St. Louis (J.E.M.); the Department of Surgery, VA Pittsburgh Healthcare System, Pittsburgh (M.A. Wilson); the Department of Surgery, University of Michigan, Ann Arbor (L.M.N.); the Department of Surgery, University of Miami Miller School of Medicine, Miami (N.N.); the Department of Surgery, Wake Forest School of Medicine, Winston-Salem, NC (P.R.M.); the Department of Surgery, University of South Carolina, Columbia (C.M.W.); University of California, San Diego, San Diego (R.C.), the Department of Surgery, UC Davis Medical Center, Sacramento (C.S.C.), and the Department of Surgery, University of California, San Francisco, San Francisco (M.A. West) - all in California; the Department of Surgery, University of Texas Health Science Center at San Antonio, San Antonio (D.L.D.); the Department of Surgery, University of Medicine and Dentistry of New Jersey, Newark (S.F.L.); the Department of Surgery, University of Minnesota Medical School, Minneapolis (K.L.B.); the Department of Surgery, University of Louisville School of Medicine, Louisville, KY (W.G.C.); and the Department of Surgery, Johns Hopkins University School of Medicine, Baltimore (P.A.L.).

PMID: 25992746
PMCID: PMC4469182
DOI: 10.1056/NEJMoa1411162

Randomized Controlled Trial

Trial of short-course antimicrobial therapy for intraabdominal infection

Robert G Sawyer et al. N Engl J Med. 2015.

. 2015 May 21;372(21):1996-2005.

doi: 10.1056/NEJMoa1411162.

Collaborators

STOP-IT Trial Investigators:
Joseph Cuschieri, David C Evans, Charles M Friel, Chinedu Njoku, Stanislaw P Stawicki

Affiliation

¹ From the Department of Surgery, University of Virginia Health System, Charlottesville (R.G.S., C.A.G., K.P.); the Department of Surgery, Virginia Commonwealth University, Richmond (T.M.D.); the Department of Surgery, Case Western Reserve University, Cleveland (J.A.C.); the Department of Surgery, University of Toronto, Toronto (A.B.N., O.D.R.); the Department of Surgery, University of Washington, Seattle (H.L.E., E.P.D.); the Department of Surgery, Beth Israel Deaconess Medical Center (C.H.C.), and the Department of Surgery, Brigham and Women's Hospital (R.A.) - both in Boston; the Department of Surgery, Maricopa Integrated Health System, Phoenix, AZ (P.J.O.); the Department of Surgery, Washington University, St. Louis (J.E.M.); the Department of Surgery, VA Pittsburgh Healthcare System, Pittsburgh (M.A. Wilson); the Department of Surgery, University of Michigan, Ann Arbor (L.M.N.); the Department of Surgery, University of Miami Miller School of Medicine, Miami (N.N.); the Department of Surgery, Wake Forest School of Medicine, Winston-Salem, NC (P.R.M.); the Department of Surgery, University of South Carolina, Columbia (C.M.W.); University of California, San Diego, San Diego (R.C.), the Department of Surgery, UC Davis Medical Center, Sacramento (C.S.C.), and the Department of Surgery, University of California, San Francisco, San Francisco (M.A. West) - all in California; the Department of Surgery, University of Texas Health Science Center at San Antonio, San Antonio (D.L.D.); the Department of Surgery, University of Medicine and Dentistry of New Jersey, Newark (S.F.L.); the Department of Surgery, University of Minnesota Medical School, Minneapolis (K.L.B.); the Department of Surgery, University of Louisville School of Medicine, Louisville, KY (W.G.C.); and the Department of Surgery, Johns Hopkins University School of Medicine, Baltimore (P.A.L.).

PMID: 25992746
PMCID: PMC4469182
DOI: 10.1056/NEJMoa1411162

Erratum in

Trial of Short-Course Antimicrobial Therapy for Intraabdominal Infection.
[No authors listed] [No authors listed] N Engl J Med. 2018 Feb 15;378(7):686. doi: 10.1056/NEJMx180006. Epub 2018 Jan 25. N Engl J Med. 2018. PMID: 29370580 No abstract available.

Abstract

Background: The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics. The appropriate duration of antimicrobial therapy remains unclear.

Methods: We randomly assigned 518 patients with complicated intraabdominal infection and adequate source control to receive antibiotics until 2 days after the resolution of fever, leukocytosis, and ileus, with a maximum of 10 days of therapy (control group), or to receive a fixed course of antibiotics (experimental group) for 4±1 calendar days. The primary outcome was a composite of surgical-site infection, recurrent intraabdominal infection, or death within 30 days after the index source-control procedure, according to treatment group. Secondary outcomes included the duration of therapy and rates of subsequent infections.

Results: Surgical-site infection, recurrent intraabdominal infection, or death occurred in 56 of 257 patients in the experimental group (21.8%), as compared with 58 of 260 patients in the control group (22.3%) (absolute difference, -0.5 percentage point; 95% confidence interval [CI], -7.0 to 8.0; P=0.92). The median duration of antibiotic therapy was 4.0 days (interquartile range, 4.0 to 5.0) in the experimental group, as compared with 8.0 days (interquartile range, 5.0 to 10.0) in the control group (absolute difference, -4.0 days; 95% CI, -4.7 to -3.3; P<0.001). No significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes.

Conclusions: In patients with intraabdominal infections who had undergone an adequate source-control procedure, the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 8 days) that extended until after the resolution of physiological abnormalities. (Funded by the National Institutes of Health; STOP-IT ClinicalTrials.gov number, NCT00657566.).

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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

**Figure 1. Enrollment, Randomization, and Treatment**
All enrolled patients had complicated intraabdominal infection and adequate source control. The control group consisted of patients who received antibiotics until 2 days after resolution of fever, leukocytosis, and ileus, with a maximum of 10 days of therapy, and the experimental group received a fixed course of antibiotics for 4±1 calendar days.

**Figure 2. Kaplan–Meier Time-to-Event Curves for the Composite Primary Outcome, According to Treatment Group**
The composite primary outcome was surgical-site infection, recurrent intraabdominal infection, or death.

**Figure 3. Primary Composite Outcome in Key Subgroups**
The median proportions of patients with the composite outcome are shown. I bars indicate the interquartile range.

See this image and copyright information in PMC

Comment in

Antibiotics for abdominal sepsis.
Wenzel RP, Edmond MB. Wenzel RP, et al. N Engl J Med. 2015 May 21;372(21):2062-3. doi: 10.1056/NEJMe1503936. N Engl J Med. 2015. PMID: 25992751 No abstract available.
Short-course antimicrobial therapy may be clinically similar to a longer course for complicated intra-abdominal infections.
Zakrison TL. Zakrison TL. Evid Based Med. 2015 Oct;20(5):182-3. doi: 10.1136/ebmed-2015-110243. Epub 2015 Aug 20. Evid Based Med. 2015. PMID: 26294787 No abstract available.
[Can the duration of antibiotic therapy be reduced to 4 days in intra-abdominal infections?].
Pariente A. Pariente A. Rev Prat. 2015 Jun;65(6):763. Rev Prat. 2015. PMID: 26298895 French. No abstract available.
Short-Course Antimicrobial Therapy for Intraabdominal Infection.
Guidry CA, Sawyer RG. Guidry CA, et al. N Engl J Med. 2015 Oct 15;373(16):1578. doi: 10.1056/NEJMc1508694. N Engl J Med. 2015. PMID: 26466002 Free PMC article.
Short-Course Antimicrobial Therapy for Intraabdominal Infection.
Marks M, Pollara G. Marks M, et al. N Engl J Med. 2015 Oct 15;373(16):1577. doi: 10.1056/NEJMc1508694. N Engl J Med. 2015. PMID: 26466003 No abstract available.
Short-Course Antimicrobial Therapy for Intraabdominal Infection.
Roger C, Bertrand M, Muller L. Roger C, et al. N Engl J Med. 2015 Oct 15;373(16):1577-8. doi: 10.1056/NEJMc1508694. N Engl J Med. 2015. PMID: 26466004 No abstract available.
ACP Journal Club. After source control in intraabdominal infections, 4-day and longer-duration antibiotics did not differ at 30-days.
Kadri S, O'Grady NP. Kadri S, et al. Ann Intern Med. 2015 Oct 20;163(8):JC6. doi: 10.7326/ACPJC-2015-163-8-006. Ann Intern Med. 2015. PMID: 26502143 No abstract available.

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References

1. DeFrances CJ, Cullen KA, Kozak LJ. National Hospital Discharge Survey: 2005 annual summary with detailed diagnosis and procedure data. Vital Health Stat 13. 2007;165:1–209. - PubMed
1. Sartelli M, Catena F, Ansaloni L, et al. Complicated intra-abdominal infections worldwide: the definitive data of the CIAOW Study. World J Emerg Surg. 2014;9:37. - PMC - PubMed
1. Inui T, Haridas M, Claridge JA, Malangoni MA. Mortality for intra-abdominal infection is associated with intrinsic risk factors rather than the source of infection. Surgery. 2009;146:654–661. - PubMed
1. Riccio LM, Popovsky KA, Hranjec T, et al. Association of excessive duration of antibiotic therapy for intra-abdominal infection with subsequent extra-abdominal infection and death: a study of 2,552 consecutive infections. Surg Infect (Larchmt) 2014;15:417–424. - PMC - PubMed
1. Christou NV, Barie PS, Dellinger EP, Waymack JP, Stone HH. Surgical Infection Society intra-abdominal infection study: prospective evaluation of management techniques and outcome. Arch Surg. 1993;128:193–198. - PubMed

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[1] DeFrances CJ, Cullen KA, Kozak LJ. National Hospital Discharge Survey: 2005 annual summary with detailed diagnosis and procedure data. Vital Health Stat 13. 2007;165:1–209. - PubMed

[2] DeFrances CJ, Cullen KA, Kozak LJ. National Hospital Discharge Survey: 2005 annual summary with detailed diagnosis and procedure data. Vital Health Stat 13. 2007;165:1–209. - PubMed

[3] Sartelli M, Catena F, Ansaloni L, et al. Complicated intra-abdominal infections worldwide: the definitive data of the CIAOW Study. World J Emerg Surg. 2014;9:37. - PMC - PubMed

[4] Sartelli M, Catena F, Ansaloni L, et al. Complicated intra-abdominal infections worldwide: the definitive data of the CIAOW Study. World J Emerg Surg. 2014;9:37. - PMC - PubMed

[5] Inui T, Haridas M, Claridge JA, Malangoni MA. Mortality for intra-abdominal infection is associated with intrinsic risk factors rather than the source of infection. Surgery. 2009;146:654–661. - PubMed

[6] Inui T, Haridas M, Claridge JA, Malangoni MA. Mortality for intra-abdominal infection is associated with intrinsic risk factors rather than the source of infection. Surgery. 2009;146:654–661. - PubMed

[7] Riccio LM, Popovsky KA, Hranjec T, et al. Association of excessive duration of antibiotic therapy for intra-abdominal infection with subsequent extra-abdominal infection and death: a study of 2,552 consecutive infections. Surg Infect (Larchmt) 2014;15:417–424. - PMC - PubMed

[8] Riccio LM, Popovsky KA, Hranjec T, et al. Association of excessive duration of antibiotic therapy for intra-abdominal infection with subsequent extra-abdominal infection and death: a study of 2,552 consecutive infections. Surg Infect (Larchmt) 2014;15:417–424. - PMC - PubMed

[9] Christou NV, Barie PS, Dellinger EP, Waymack JP, Stone HH. Surgical Infection Society intra-abdominal infection study: prospective evaluation of management techniques and outcome. Arch Surg. 1993;128:193–198. - PubMed

[10] Christou NV, Barie PS, Dellinger EP, Waymack JP, Stone HH. Surgical Infection Society intra-abdominal infection study: prospective evaluation of management techniques and outcome. Arch Surg. 1993;128:193–198. - PubMed

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Trial of short-course antimicrobial therapy for intraabdominal infection

Collaborators

Affiliation

Trial of short-course antimicrobial therapy for intraabdominal infection

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Collaborators

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Erratum in

Abstract

Conflict of interest statement

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Cited by

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