Burden of Antibiotic Resistance in Gram-Negative Infections in Dutch Hospitals

NCT02007343 | Completed

• 2 other identifiers: GRAND-ABC205200007
• Study Type: observational
• Target: 3,895
• Locations: 1 country
• Sites: 8

Brief Summary

This study aims to assess how large an additional disease burden and what extra costs are generated by antibiotic resistance in patients suffering from infections caused by gram-negative bacteria, such as Escherichia coli and Pseudomonas aeruginosa, in hospitals in the Netherlands.

Conditions

Infection Resistant to Drugs; Gram-Negative Bacterial Infection

Keywords

Enterobacteriaceae; Pseudomonas; Acinetobacter; Stenotrophomonas; Mortality; Morbidity; Cost of Illness; Causality; Multicenter Study; Cohort Studies; Case-Control Studies; Prospective Studies; Follow-up Studies

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  Death (whether in-hospital or after discharge) from any cause, as apparent from medical record or municipal registry.

  Up to 30 days

Secondary Outcomes (3)

• Costs

  Hospital stay (all patients; expected average 1 week) and up to 90 days (follow-up patients)

• DALYs

  Up to 90 days

• Length of stay

  Hospital stay (expected average 1 week)

Other Outcomes (1)

• QALYs

  Up to 90 days

Study Arms (2)

Patients with gram-negative infections

Sample (5/week/hospital) of all patients in a hospital that meet all of the following: * meeting the criteria of at least one infection entity based on (modified) definitions of the Center for Disease Control and Infection Prevention (CDC; Am J Infect Control 2008;36:309-32) (restricted to infections that have septic potential); * a culture with a gram-negative isolate (Enterobacteriaceae / Pseudomonas aeruginosa / Acinetobacter spp. / Stenotrophomonas maltophilia) with minimal inhibitory concentration (MIC) results from an automated system available that can be used to identify such an infection entity according to these criteria; * receipt of antibiotics (oral, intravenous or intramuscular) for this infection, the choice of which is determined by the culture with the gram-negative (i.e. this isolate is seen as the causative pathogen); * were admitted to the hospital during (part of) the infection episode. Date of entry into cohort: date of index culture of infection episode

Non-infected patients

Matched sample of all patients that (1) were admitted to the hospital and (2) did not have a gram-negative infection according to the 4 criteria set out in the other group on the date used for matching. Selected by matching 1:1 to patients with gram-negative infections on (1) hospital, (2) length of hospital stay on the date the index culture for the infected patient was obtained, and (3) age. Date of cohort entry: date of index culture of matched infected patient

Eligibility Criteria

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

Study Population

Patients admitted to hospitals

You may qualify if:

• Please refer to descriptions of two cohorts

You may not qualify if:

• Patients on children's wards
• Patients admitted to wards for long-term care or psychiatric wards, that were not subsequently admitted to acute care wards as a consequence of the infection
• Patients admitted to wards that are excluded for logistic reasons such as the non-availability of electronic patient files, that were not subsequently admitted to included acute care wards as a consequence of the infection
• Patients that have been included in the cohort of infected patients during the same hospitalization or within the past 30 (if not eligible for follow-up) or 90 (if eligible for follow-up) days

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (8)

Meander Medisch Centrum

Amersfoort, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Tergooi

Hilversum, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Gram-Negative Bacterial Infections; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Marc JM Bonten, MD PhD

  UMC Utrecht, Utrecht, the Netherlands

  PRINCIPAL INVESTIGATOR

• Heidi SM Ammerlaan, MD PhD

  Catharina Hospital, Eindhoven, the Netherlands

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Molecular Epidemiology of Infectious Diseases

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 10, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

NL (8)