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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Mount Sinai Hospital, Canada
Study ID
NCT06004739
Status
Recruiting
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Conditions

  • Infectious Disease

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Start Antibiotics / Continue Antibiotics for treatment of bacteriuria — DRUG
    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.
  • No Antibiotics for treatment of bacteriuria — OTHER
    Participants will be randomized to no antibiotics

Study Details

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.

Key Dates

Start date
May 18, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Antibiotics
    Participants will be randomized to start or continue with antibiotics. Antibiotic type and duration targeted to lower urinary tract infection as directed by the Most Responsible Physician (MRP).
  • Other: No Antibiotics
    Participants will be randomized to no antibiotics

Primary Outcome Measure

Delirium at day 7 or at day of hospital discharge, whichever is earliest [ Time Frame: Delirium will be assessed at the first of day 7 or discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Ajay Bhasin, MD

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By research site
Northwestern Memorial Hospital· Chicago, IL

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