Antibiotic Stewardship and Infection Control in Patients at High Risk of Developing Infection by Clostridium Difficile, Vancomycin-Resistant Enterococci or Multi-Resistant Gram-Negatives

NCT03250104 | Completed DMC

• 1 other identifier: TTU HAARBI 8.810
• Study Type: observational
• Target: 80,000
• Locations: 1 country
• Sites: 1

Brief Summary

Throughout project, the investigators design, evaluate and disseminate infection control and antibiotic stewardship (ABS) measures aimed at reducing the incidence of Clostridium difficile infection (CDI). The measures will focus on known departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rates, which were identified throughout previous studies. The infection control package will include staff training, hand hygiene programs and disinfection measures. Throughout the ABS package, investigators will develop and implement ABS measures specifically designed for patients at the highest risk of developing hospital-acquired infections, i.e. those treated on hematological/oncological wards. Potentially useful ABS actions even in critically ill patients are early reduction of exposure based on microbiological results, timely cessation of anti-infective treatment, thoughtful implementation of screening measures and biomarkers, defined approaches to patients known to be allergic to penicillins, and vigorous enforcement of clinical and microbiological diagnosis of infection focus. The IC and ABS measures aim at educating and assisting clinical personnel in realizing treatments according to official guidelines. There will not be a direct contact between study personnel and patient. There will be no direct recruitment of patients.

Conditions

Clostridium Difficile Infection; VRE Infection; Nosocomial Infection; MRGN Bacteria

Keywords

antimicrobial stewardship; infection control; nosocomial infection; clostridium difficile; MRGN bacteria; health-care associated pathogens; VRE

Outcome Measures

Primary Outcomes (1)

• CDI incidence

  Significant reduction of the overall CDI incidence on intervention wards following implementation of the combined IC and ABS bundles in pre-post analysis stratified by center.

  Baseline and every 3 months up to 144 weeks

Secondary Outcomes (6)

• Effectiveness of IC bundle through incidence of CDI or BSI by VRE and MRGN

  Baseline and every 3 months up to 144 weeks

• PPI usage

  Baseline and every 3 months up to 144 weeks

• Improvement of process indicators by calculating disinfectant consumption and antibiotic consumption

  Baseline and every 3 months up to 144 weeks

• Effectiveness of ABS interventions by continuously measuring RDDs

  Baseline and every 3 months up to 144 weeks

• Antibiotic consumption

  Baseline and every 3 months up to 144 weeks

Interventions

Infection Control OTHER

The infection control bundle will include staff training, hand hygiene programs, disinfection measures, and contact isolation. Physicians will be discouraged to prescribe proton pump inhibitors (PPIs) where not explicitly needed. The intervention bundle will be defined based on current literature. For implementation, the investigator will adapt the bundle to specific local needs, discuss with the responsible department heads and ward staff, perform training and disseminate standards of care.

Antibiotic Stewardship OTHER

Antibiotic stewards will develop local standards of procedure based on the provided training and guidelines. They will then train the responsible staff and disseminate guidelines as best suited for the local work environment, e.g. as pocket cards, posters, or electronically. Point-prevalence investigations and "antibiotic visits" will assure adherence to guidelines.

Eligibility Criteria

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

Study Population

Patients admitted on wards with high incidence of CDI.

You may qualify if:

• \- patients admitted to departments with high incidence of CDI, i.e. a) hematology/oncology, b) other departments/wards demonstrating above-average infection rates (identified by previous studies)

You may not qualify if:

• \- patients admitted in opthalmology, paediatrics, psychiatry

Sponsors & Collaborators

• University Hospital of Cologne: lead
• Charite University, Berlin, Germany: collaborator
• University Hospital Freiburg: collaborator
• University of Hamburg-Eppendorf: collaborator
• University Hospital Lübeck: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Related Publications (9)

• Gastmeier P, Weitzel-Kage D, Behnke M, Eckmanns T. Surveillance of Clostridium difficile-associated diarrhoea with the German nosocomial infection surveillance system KISS (CDAD-KISS). Int J Antimicrob Agents. 2009 Mar;33 Suppl 1:S19-23. doi: 10.1016/S0924-8579(09)70011-1.

  PMID: 19303563 BACKGROUND

• Meyer E, Gastmeier P, Weizel-Kage D, Schwab F. Associations between nosocomial meticillin-resistant Staphylococcus aureus and nosocomial Clostridium difficile-associated diarrhoea in 89 German hospitals. J Hosp Infect. 2012 Nov;82(3):181-6. doi: 10.1016/j.jhin.2012.07.022. Epub 2012 Sep 27.

  PMID: 23021304 BACKGROUND

• Vonberg RP, Kuijper EJ, Wilcox MH, Barbut F, Tull P, Gastmeier P; European C difficile-Infection Control Group; European Centre for Disease Prevention and Control (ECDC); van den Broek PJ, Colville A, Coignard B, Daha T, Debast S, Duerden BI, van den Hof S, van der Kooi T, Maarleveld HJ, Nagy E, Notermans DW, O'Driscoll J, Patel B, Stone S, Wiuff C. Infection control measures to limit the spread of Clostridium difficile. Clin Microbiol Infect. 2008 May;14 Suppl 5:2-20. doi: 10.1111/j.1469-0691.2008.01992.x.

  PMID: 18412710 BACKGROUND

• Vehreschild MJ, Hamprecht A, Peterson L, Schubert S, Hantschel M, Peter S, Schafhausen P, Rohde H, Lilienfeld-Toal MV, Bekeredjian-Ding I, Libam J, Hellmich M, Vehreschild JJ, Cornely OA, Seifert H. A multicentre cohort study on colonization and infection with ESBL-producing Enterobacteriaceae in high-risk patients with haematological malignancies. J Antimicrob Chemother. 2014 Dec;69(12):3387-92. doi: 10.1093/jac/dku305. Epub 2014 Aug 6.

  PMID: 25103492 BACKGROUND

• Vehreschild MJ, Weitershagen D, Biehl LM, Tacke D, Waldschmidt D, Tox U, Wisplinghoff H, Von Bergwelt-Baildon M, Cornely OA, Vehreschild JJ. Clostridium difficile infection in patients with acute myelogenous leukemia and in patients undergoing allogeneic stem cell transplantation: epidemiology and risk factor analysis. Biol Blood Marrow Transplant. 2014 Jun;20(6):823-8. doi: 10.1016/j.bbmt.2014.02.022. Epub 2014 Mar 6.

  PMID: 24607558 BACKGROUND

• Borde JP, Litterst S, Ruhnke M, Feik R, Hubner J, deWith K, Kaier K, Kern WV. Implementing an intensified antibiotic stewardship programme targeting cephalosporin and fluoroquinolone use in a 200-bed community hospital in Germany. Infection. 2015 Feb;43(1):45-50. doi: 10.1007/s15010-014-0693-2. Epub 2014 Oct 25.

  PMID: 25344419 BACKGROUND

• Borde JP, Kaier K, Steib-Bauert M, Vach W, Geibel-Zehender A, Busch H, Bertz H, Hug M, de With K, Kern WV. Feasibility and impact of an intensified antibiotic stewardship programme targeting cephalosporin and fluoroquinolone use in a tertiary care university medical center. BMC Infect Dis. 2014 Apr 15;14:201. doi: 10.1186/1471-2334-14-201.

  PMID: 24731220 BACKGROUND

• Vehreschild JJ, Bohme A, Cornely OA, Kahl C, Karthaus M, Kreuzer KA, Maschmeyer G, Mousset S, Ossendorf V, Penack O, Vehreschild MJGT, Bohlius J. Prophylaxis of infectious complications with colony-stimulating factors in adult cancer patients undergoing chemotherapy-evidence-based guidelines from the Infectious Diseases Working Party AGIHO of the German Society for Haematology and Medical Oncology (DGHO). Ann Oncol. 2014 Sep;25(9):1709-1718. doi: 10.1093/annonc/mdu035. Epub 2014 Mar 14.

  PMID: 24631945 BACKGROUND

• Vehreschild JJ, Morgen G, Cornely OA, Hartmann P, Koch S, Kalka-Moll W, Wyen C, Vehreschild MJ, Lehmann C, Gillor D, Seifert H, Kremer G, Fatkenheuer G, Jung N. Evaluation of an infectious disease consultation programme in a German tertiary care hospital. Infection. 2013 Dec;41(6):1121-8. doi: 10.1007/s15010-013-0512-1. Epub 2013 Aug 8.

  PMID: 23925637 BACKGROUND

MeSH Terms

Conditions

Clostridium Infections; Cross Infection

Interventions

Infection Control; Antimicrobial Stewardship

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Drug Utilization Review; Drug Utilization; Pharmacy Administration; Organization and Administration; Health Services Administration; Utilization Review; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Jörg Janne Vehreschild, MD

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: August 15, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)