CABI: Antibiotic Duration for Complicated Intra-ABdominal Infection

NCT03265834 | Completed Phase 2

• 1 other identifier: MB16/156
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Complicated intra-ABdominal Infections (CABIs) are abdominal infections where there is an abscess inside the abdomen, or a hole (perforation) in an abdominal organ such that infected material e.g. faeces, leaks into the abdominal cavity. A recent review of CABIs after gut surgery found that they can occur in several ways. They can occur in different parts of the abdomen, can be different sizes, and may or may not be caused by a perforated bowel. Management includes, where possible, surgical drainage of an abscess or treatment of the damaged bowel. In addition, all patients are given antibiotic therapy. Despite the varied ways that CABIs occur, we currently tend to treat all CABIs with antibiotics in a similar way. CABIs are associated with significant morbidity and mortality. Despite a significant amount of disease there is little clinical evidence with which to base treatment on. One research study evaluated a short course of antibiotics (4 days) compared with a longer course (up to 10 days) in combination with surgical removal of infection. There was little difference in outcomes, but in both groups about 1 out of every 7 patients had a relapse. A recent review of patients with CABI in Leeds, not in a research study and where surgical removal infection is uncommon and antibiotic durations were short, showed that the risk of relapse was even higher (about 1 in every 3 patients). The antibiotic management of CABIs in the UK is variable and involves giving between 4 days to 28 days of antibiotics. In summary, there is an unacceptably high relapse rate in patients treated for CABI, and uncertainty about the best length of antibiotic therapy that should be used to prevent these relapses. We therefore propose to investigate if long course antibiotic therapy (28 days) is more effective than short course antibiotics (≤10 days) in preventing relapses of CABI.

Conditions

Complicated Intraabdominal Infections

Outcome Measures

Primary Outcomes (2)

• Number of participants willing to be randomised, the willingness of clinicians to allow participants to be recruited & follow up rates.

  Screening logs, recruitment rates and follow up rates will be recorded to determine the feasibility of performing a larger study.

  90 days

• Number of participants who have their antibiotic therapy changed as a consequence of allocation to a certain treatment arm.

  Antibiotic therapy received including any changes to treatment will be recorded.

  Either ≤ 10 days or 28 days depending on allocation.

Secondary Outcomes (9)

• The number of participants who relapse after treatment of complicated intra-abdominal infection.

  90 days

• Number of all infections after treatment of complicated intra-abdominal infection

  90 days

• Total antibiotic consumption

  90 days

• Length of hospital stay within 90 days of diagnosis

  90 days

• Mortality rate after treatment of complicated intra-abdominal infection.

  90 days

Study Arms (2)

Long course antibiotic therapy (28 days)

EXPERIMENTAL

Antibiotic therapy for a duration of 28 days

Other: 28 days of antibiotics

Short course antibiotic therapy (≤10 days)

ACTIVE COMPARATOR

Antibiotic therapy for a duration of ≤10 days

Other: < 10 days of antibiotics

Interventions

< 10 days of antibiotics OTHER

Antibiotic duration

Short course antibiotic therapy (≤10 days)

28 days of antibiotics OTHER

Antibiotic duration

Long course antibiotic therapy (28 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18 years
• The diagnosis of a definite CABI
• Capable of giving informed consent
• No practical or clinical barriers to consuming 28 days of antibiotic therapy, which may include consumption of antibiotics at home

You may not qualify if:

• a CABI diagnosed within the previous year
• a CABI diagnosed \>6 days prior to screening
• uncomplicated cholecystitis/cholangitis/gall bladder empyema (no perforation or extra-biliary abscess
• a skin and soft tissue infection/abscess not communicating with the peritoneal space
• primary complicated or uncomplicated appendicitis managed surgically
• intra-abdominal infection associated with pancreatitis, pelvic inflammatory disease, primary (spontaneous) bacterial peritonitis (SBP), continuous ambulatory peritoneal dialysis peritonitis (CAPD peritonitis) and Clostridium difficile infection. concurrent infection requiring more than 10 days of therapy
• Infection with a highly resistant bacterium such that antibiotic treatment is considered to be a significantly sub-optimal by the treating microbiologist e.g. multi-resistant carbapenemase producing Entrobacteriacea

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, LS1 3EX, United Kingdom

Location

Related Publications (8)

• Solomkin JS, Mazuski JE, Bradley JS, Rodvold KA, Goldstein EJ, Baron EJ, O'Neill PJ, Chow AW, Dellinger EP, Eachempati SR, Gorbach S, Hilfiker M, May AK, Nathens AB, Sawyer RG, Bartlett JG. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010 Jan 15;50(2):133-64. doi: 10.1086/649554.

  PMID: 20034345 BACKGROUND

• Rothwell A, Burke D, Burnside G, Kirby A. Characteristics of Organ Space Surgical Site Infection after colorectal surgery. In preparation.

  BACKGROUND

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

  PMID: 18350768 BACKGROUND

• Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Regnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.

  PMID: 7674528 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.

  PMID: 18064739 BACKGROUND

• Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jun 29;338:b2393. doi: 10.1136/bmj.b2393.

  PMID: 19564179 BACKGROUND

• 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.

  PMID: 25992746 BACKGROUND

• Ahmed S, Brown R, Pettinger R, Vargas-Palacios A, Burke D, Kirby A. The CABI Trial: an Unblinded Parallel Group Randomised Controlled Feasibility Trial of Long-Course Antibiotic Therapy (28 Days) Compared with Short Course (</= 10 Days) in the Prevention of Relapse in Adults Treated for Complicated Intra-Abdominal Infection. J Gastrointest Surg. 2021 Apr;25(4):1045-1052. doi: 10.1007/s11605-020-04545-2. Epub 2020 Mar 5.

  PMID: 32140989 DERIVED

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Andrew Kirby, MBChB

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate clinical professor

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 29, 2017
• Study Start: August 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)