All studies
RecruitingNAINTERVENTIONAL

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

This study is investigating if antibiotics are helpful for older adults (aged 60 and over) who are experiencing acute confusion, known as delirium, and also have bacteria in their urine. Many older people in hospital who become confused are given antibiotics because bacteria are often found in their urine. However, it's common for older people to have bacteria in their urine without actually having a urine infection. This makes it hard to know if the confusion is caused by an infection. The study aims to find out if giving antibiotics in these situations truly helps to improve the delirium, especially when there are no clear signs of a urine infection like pain or needing to go to the toilet more often.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Mount Sinai Hospital, Canada
Enrolment target
550
Start
18 May 2024
Estimated completion
01 Sep 2027

What is this study about?

When older adults are admitted to hospital, they can sometimes become confused very quickly. Doctors call this 'delirium'. It's really important to find out why someone is confused so they can get the right treatment. One possible cause of delirium is an infection.

Often, when a urine sample is tested from someone with delirium, bacteria are found. However, finding bacteria in urine is actually quite common in older people, even when they're not unwell. This means that just finding bacteria doesn't automatically mean there's a proper infection that needs treating with antibiotics. People who are confused often can't tell doctors if they have symptoms of a urine infection, like pain when they wee or needing to go to the toilet a lot, which makes it even harder to know if antibiotics are needed.

Because it's so difficult to be sure, many older adults with delirium and bacteria in their urine are given antibiotics. But we don't actually know if these antibiotics really help to improve their confusion in these specific cases. This study wants to answer that question: do antibiotics make a difference for older people with delirium and bacteria in their urine when they don't have other clear signs of a urine infection?

Key takeaways

  • Study looks at antibiotics for confusion (delirium) in older adults.
  • Specifically focuses on those with bacteria in urine but no clear infection signs.
  • Aims to see if antibiotics improve delirium in these cases.
  • Participants will be randomly assigned to antibiotic or no-antibiotic groups.
  • Findings could improve care for confused older adults.

Who may be eligible?

This study is looking for volunteers who are 60 years old or older and have recently been admitted to a hospital ward, including rehabilitation hospitals. To join, you would need to be experiencing delirium (acute confusion) that started or got worse recently, and a doctor would have confirmed this. You would also need to have had fewer than 24 hours of antibiotics for this current illness before being assessed for the study. Additionally, your urine test would need to show either white blood cells or bacteria.

You would not be able to join if you have a fever (temperature over 37.9°C or 100.2°F) in the last two days, or if you have clear signs of a urine infection, like new pain when you wee, or pain in your back or side that suggests a kidney infection. You also wouldn't be able to take part if your doctor feels you need antibiotics for a different reason, like a chest infection, or if you've had a urinary catheter in for more than 72 hours. Finally, if you've already received a specific single-dose antibiotic for a urine infection, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 60 years old or older?
  2. Are you currently in hospital and experiencing confusion (delirium)?
  3. Have you started antibiotics for this illness less than 24 hours ago, or not at all?
  4. Does your urine test show either white blood cells or bacteria?
  5. Do you *not* have a fever or clear signs of a urine infection like pain when you wee?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full assessment to see if you meet all the requirements. If you do, you would then be randomly sorted into one of three groups. One group would receive antibiotics for their bacteriuria (bacteria in urine), another group would continue any antibiotics they might have already started, and a third group would not receive antibiotics specifically for the bacteria in their urine. The study team would carefully monitor your health and your delirium throughout your hospital stay. They would also keep track of any changes in your condition or symptoms. The total duration of your participation would depend on how long you remain in hospital until your condition is stable or you are discharged.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study could be that it helps doctors understand the best way to treat delirium in older adults, improving care for future patients. For those who receive antibiotics, there are risks like side effects (e.g., upset stomach) or developing antibiotic resistance. For those who don't receive antibiotics, there's a risk that an infection might get worse if it was the cause of the delirium. You would be closely monitored by hospital staff throughout the study. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without it affecting your usual medical care.

Locations (7)

  • Northwestern Memorial Hospital
    Verified postcode
    Chicago, United States· Not yet recruiting
  • The Ottawa Hospital Civic Campus
    Verified postcode
    Ottawa, Canada· Not yet recruiting
  • The Ottawa Hospital General Campus
    Verified postcode
    Ottawa, Canada· Not yet recruiting
  • Hennick Bridgepoint Hospital
    Verified postcode
    Toronto, Canada· Not yet recruiting
  • Michael Garron Hospital
    Verified postcode
    Toronto, Canada· Recruiting
  • Mount Sinai Hospital
    Verified postcode
    Toronto, Canada· Recruiting
  • Toronto General Hospital
    Verified postcode
    Toronto, Canada· Not yet recruiting

Common questions

What is delirium?

Delirium is a sudden and severe change in a person's mental state, causing confusion, changes in attention, and awareness of their surroundings.

What does 'bacteria in urine' mean?

It means germs have been found in the urine sample. This can happen with or without a full infection, especially in older people.

Will I definitely get antibiotics if I join the study?

No, you will be randomly assigned to one of three groups: one that starts antibiotics, one that continues antibiotics if already started, or one that doesn't receive antibiotics for urine bacteria.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

What happens after the study?

The study aims to improve understanding of how to best treat delirium in older adults, which could lead to better care for patients in the future.

How to find out more

Michael Fralick, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Antibiotics for Delirium in Older Adults With No Clear Urina…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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