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

Key facts

Who runs it
Mount Sinai Hospital, Canada
Where
Chicago, United StatesSee the siteAlso in 1 other country, 6 sites
Trial code
Status
Recruiting
People taking part
550 people, planned
Started
18 May 2024
Expected to end
Sept 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Start Antibiotics / Continue Antibiotics for treatment of bacteriuria
  • No Antibiotics for treatment of bacteriuria
Record updated
19 September 2024

Who can take part

Age
60 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Signs of lower urinary tract infection symptoms (such as new dysuria) or upper urinary symptoms (such as costovertebral tenderness)
  • Fever (temperature > 37.9C or > 100.2F) in the past 48 hours
  • 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)

Where in United States

Also in 1 other country, 6 sites

  • Northwestern Memorial HospitalChicago, United StatesContact: Ajay Bhasin, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • AntibioticsOther group

    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).

    Treatment: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria

  • No AntibioticsOther group

    Participants will be randomized to no antibiotics

    Treatment: No Antibiotics for treatment of bacteriuria

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
19 September 2024