Impact of Prescription Quality, Infection Control and Antimicrobial Stewardship on Gut Microbiota Domination by Healthcare-Associated Pathogens

NCT03765528 | Unknown

• 1 other identifier: PILGRIM
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Extended-spectrum beta-lactamase producing Enterobacteriaceae (EPE), vancomycin-resistant enterococci (VRE) and Clostridium difficile have become a major threat to hospitalised patients worldwide. We hypothesize that receiving inappropriate antibacterial treatment places patients at high risk of intestinal domination and subsequent infection by these bacteria. Further analyses will address cost-effectiveness of specific interventions, behavioural analyses of the decision process leading to inappropriate antibacterial treatment, and the rate of undetected colonization with EPE/VRE/C. difficile on admission.

Conditions

Patients at High Risk of Antibacterial Treatment Upon Admission

Keywords

Clostridium difficile; Extended-Spectrum β-Lactamase producing Enterobacteriaceae; Vancomycin-resistant enterococci; Antimicrobial resistance; Microbiome; Nosocomial infection; Antimicrobial Stewardship; Infection Control

Outcome Measures

Primary Outcomes (1)

• Impact of inappropriate antibacterial prescription on intestinal microbiota domination by healthcare associated pathogens

  The differential impact of inappropriate antibacterial prescription compared to adequate or no antibacterial prescription on intestinal microbiota domination by EPE or VRE or infection with C. difficile measured by analysing stool samples.

  up to 6 - 36 weeks

Secondary Outcomes (6)

• Time-point of Intestinal Colonization

  Baseline and up to 6 - 36 weeks

• Time-point of Intestinal Domination

  Baseline and up to 6 - 36 weeks

• Inter-rater reliability of AMS specialists

  After complete documentation of each patient case (follow-up for 6-36 weeks) followed by completed ratings of AMS specialists

• Rationale for antibacterial prescription habits assessed by performing qualitative interviews with prescribing physicians

  After complete documentation of patient case (follow-up for 6-36 weeks) through study completion

• Correlation of prescription and AMS implementation

  Baseline, 12 months, 24 months

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

Hospitalized patients at high risk of receiving antibiotic treatment during their hospital stay will be screened for study eligibility.

You may qualify if:

• Age ≥ 18 years
• Planned treatment or high likelihood of any systemic antibacterial treatment except trimethoprim/sulfamethoxazole within the next 10 days for a duration of ≥ 5 days
• Patients able to provide a stool sample before or within 4 hours of receiving first antibiotic dosage

You may not qualify if:

• Patients who have received courses of systemic antibacterials for 7 days or more within the past two months
• Patients having received any antibacterial compound other than trimethoprim/sulfamethoxazole within 14 days prior to study enrolment except first antibiotic dosage within 4 hours prior enrolment
• Patients with diarrhea at enrolment (≥3 unformed bowel movements within 24h)
• Patients on enteral (tube fed or PEG) or parenteral nutrition
• Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge
• Patients exclusively treated as outpatients without prior hospital admission
• Previous participation in this study

Sponsors & Collaborators

• University Hospital of Cologne: lead
• University Hospital of North Norway: collaborator
• Karolinska Institutet: collaborator
• Rabin Medical Center: collaborator
• University of Latvia: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Haukeland University Hospital: collaborator
• University Hospital, Akershus: collaborator
• Helse Stavanger HF: collaborator
• Goethe University: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jörg Janne Vehreschild, MD

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Janne Vehreschild, MD

CONTACT

+49227478; joerg.vehreschild@uk-koeln.de

Annika Löhnert, MD

CONTACT

annika.loehnert@uk-koeln.de

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: November 16, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2022
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)