Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection

NCT06004739 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2024-09-19

No results posted yet for this study

Summary

Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Urine tests show that most patients experiencing delirium have bacteria in their urine, however, bacteria in the urine is common among older adults, and does not automatically indicate an infection is present. As a result it is difficult to know whether a lower urinary tract infection is present as individuals with delirium are frequently unable to report clinical signs of infection - symptoms of pain or discomfort with urination, having to urinate more frequently or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics despite the fact that it is unknown whether antibiotics help to improve delirium in cases where bacteria in the urine is present. This proposed study is a randomized controlled trial that will examine if adults (age 60 or older) with delirium and suspected infection benefit from taking antibiotics.

Conditions

Interventions

DRUG

Start Antibiotics / Continue Antibiotics for treatment of bacteriuria

Participants will be randomized to start or continue with antibiotics (with antibiotic duration determined by the Most Responsible Physician \[MRP\]). Antibiotics choice to be selected by the MRP.

OTHER

No Antibiotics for treatment of bacteriuria

Participants will be randomized to no antibiotics

Sponsors & Collaborators

  • Sault Area Hospital

    collaborator OTHER
  • Michael Garron Hospital

    collaborator OTHER
  • Unity Health Toronto

    collaborator OTHER
  • The Ottawa Hospital

    collaborator OTHER
  • Northwestern Memorial Hospital

    collaborator OTHER
  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Michael Fralick, MD, PhD · Sinai Health System

  • Chris Kandel, MD, PhD · Michael Garron Hospital

  • Nathan Stall, MD, PhD · Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-18
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06004739 on ClinicalTrials.gov