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

Обзор

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.

Вмешательства

• Препарат 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.
• Другое No Antibiotics for treatment of bacteriuria
  Participants will be randomized to no antibiotics

Первичные конечные точки

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

Вторичные конечные точки (12)

• Length of hospitalization [Срок оценки: Up to 30 days]
• Number of participants with bacteremia (bacteria isolated in blood culture) [Срок оценки: Up to 7 days]
• Number of participants who were transferred to Intensive Care Unit (ICU) [Срок оценки: Up to 7 days]
• Number of participants who had a fall [Срок оценки: Up to 7 days]
• Number of participants who were physically restrained [Срок оценки: Up to 7 days]
• Number of participants who received antipsychotics [Срок оценки: Up to 7 days]
• Days of antibiotics [Срок оценки: Up to 7 days]
• Number of participants with C. difficile infection [Срок оценки: By 30 days]
• Number of participants who died [Срок оценки: By 30 days]
• Number of participants who died [Срок оценки: By 365 days]
• Number of participants who were readmitted to hospital [Срок оценки: By 365 days]
• Number of participants who were readmitted to hospital [Срок оценки: By 30 days]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 6 центров

• The Ottawa Hospital Civic Campus — Ottawa
• The Ottawa Hospital General Campus — Ottawa
• Hennick Bridgepoint Hospital — Toronto
• Michael Garron Hospital — Toronto
• Mount Sinai Hospital — Toronto
• Toronto General Hospital — Toronto

США · 1 центр

• Northwestern Memorial Hospital — Chicago

Идентификаторы

NCT: NCT06004739 · CTO 4466

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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