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

ConditionInfectious Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorMount Sinai Hospital, Canada

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Participants will be randomized to no antibiotics

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: AntibioticsOther 1 intervention
Group B: No AntibioticsOther 1 intervention

Trial outcomes

Primary outcomes

1

Delirium at day 7 or at day of hospital discharge, whichever is earliest

Delirium will be assessed using Confusion Assessment Method (CAM). CAM assesses 4 delirium features: \[1\] inattention, \[2\] acute and fluctuating level of consciousness, \[3\] disorganized thinking and \[4\] altered mental status. For a diagnosis of delirium by CAM, the patient must display feature \[1\] AND \[2\], AND EITHER \[3\] or \[4\].

Time frame
Delirium will be assessed at the first of day 7 or discharge

Secondary outcomes

1

Length of hospitalization

Time frame
Up to 30 days
2

Number of participants with bacteremia (bacteria isolated in blood culture)

Time frame
Up to 7 days
3

Number of participants who were transferred to Intensive Care Unit (ICU)

Time frame
Up to 7 days
4

Number of participants who had a fall

Time frame
Up to 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mount Sinai Hospital, Canada

Lead sponsor

Sault Area Hospital

Collaborator

Michael Garron Hospital

Collaborator

Unity Health Toronto

Collaborator

The Ottawa Hospital

Collaborator

Northwestern Memorial Hospital

Collaborator

Source ClinicalTrials.gov
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