Recruiting

Antibiotics

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT06004739

Conditions

Infectious Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Start Antibiotics / Continue Antibiotics for treatment of bacteriuria

No Antibiotics for treatment of bacteriuria

Study Details

Brief 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

Infectious Disease

Study ID

NCT06004739

Start date

May 18, 2024

Status verified date

Sep, 2024

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion criteria

  • Age ≥ 60 and admitted to a hospital ward (including rehabilitation hospital);
  • Active delirium (defined by CAM: \[1\] inattention AND \[2\] acute and fluctuating level of consciousness, and either \[3\] disorganized thinking OR \[4\] altered mental status; OR physician's diagnosis)
  • Less than 24 hours of antibiotics (prior to trial assessment)
  • Either pyuria (defined as white blood cells detected on urinalysis or dipstick) or bacteriuria (defined as bacteria growing on urine culture)

Exclusion criteria

  • Fever (temperature > 37.9C or > 100.2F) in the past 48 hours;
  • Signs of lower urinary tract infection symptoms (such as new dysuria) or upper urinary symptoms (such as costovertebral tenderness)
  • In the opinion of the treating physician, there is a reason apart from delirium and urine test results to treat with antibiotics (e.g., pneumonia)
  • Indwelling urinary catheter for > 72 hours
  • Receipt of an antibiotic where a single dose suffices for the treatment of a UTI (such as Fosfomycin)

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

No Antibiotics for treatment of bacteriuria

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 and Locations

Central contacts

Michael Fralick, MD

(416) 586-4800mike.fralick@mail.utoronto.ca

Locations

Michael Garron Hospital

Recruiting

Toronto, Canada

Mount Sinai Hospital

Recruiting

Toronto, Canada

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • Delirium
  • Antibiotics
  • Older adults
  • Urinary Tract Infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2024-09-19.