Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Novel Diagnostics

Официальное название

Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention

Обзор

Children are commonly hospitalized because of community-acquired pneumonia. Despite the fact that many of these children have viral disease, a majority is treated with antibiotics. These antibiotics will not accelerate recovery in those with viral pneumonia and can cause harm. We are interested in exploring whether the MeMed BV - a composite biomarker assay - could be used to improve antibiotic prescribing in these children by identifying those who likely have viral disease. This proposal describes a feasibility randomized trial of this diagnostic intervention.

Вмешательства

• Диагностический тест MeMed BV + Usual Care
  We will aim to have blood drawn for MeMed BV testing within 24 hours of the first dose of IV antibiotics. We will then aim to have test results back within 24 hours of sampling.
• Другое Usual Care Alone
  Usual care can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these.

Первичные конечные точки

• Consent success [Срок оценки: Day 0]
• MeMed BV test timing [Срок оценки: before Day 2]
• MeMed BV test result reporting [Срок оценки: before Day 3]
• MeMed BV test result initial adherence [Срок оценки: before Day 4]
• MeMed BV test result delayed adherence [Срок оценки: before Day 15]
• Losses to followup [Срок оценки: before Day 30]

Вторичные конечные точки (12)

• Early clinical response [Срок оценки: Day 4]
• Days of antibiotics given specifically for CAP before hospital discharge [Срок оценки: Before discharge]
• Days of antibiotics given specifically for CAP after hospital discharge and before day 30 [Срок оценки: after hospital discharge and before day 30]
• Time to resolution of fever [Срок оценки: Before discharge]
• Time to resolution of difficulty breathing [Срок оценки: Before discharge]
• Time to resolution of hypoxaemia [Срок оценки: Before discharge]
• Length of stay in hospital [Срок оценки: Before discharge]
• Repeat hospitalization for CAP [Срок оценки: After discharge and before day 30]
• Unscheduled ED or urgent care visits [Срок оценки: After discharge and before day 30]
• Unscheduled primary care visits [Срок оценки: After discharge and before day 30]
• Development of complicated pneumonia [Срок оценки: Before Day 30]
• Acceptability of care plan to caregiver [Срок оценки: Baseline]

Критерии участия

Критерии включения

• children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:

• documented tachypnoea (>60 bpm for age <1 y, >50 bpm for 1-2 y, >40 bpm for 2-4 y, and >30 bpm for >4 y);
• cough on exam or by history;
• increased work of breathing on exam; or
• auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.

Критерии исключения

• Children will be excluded from if they have received >48h of intravenous antibiotics (eg. if transferred from another healthcare facility) or if they have a lobar consolidation that occupies the majority of a lobe on imaging, a pleural effusion that occupies more than ¼ of a lung field, or a positive blood culture for a bacterial pathogen (not a contaminant). Examples of CAP pathogens include S. pneumoniae, S. pyogenes (group A streptococcus), S. aureus, S. anginosus. Examples of contaminants that would be ignored include the coagulase-negative staphylococci and Bacillus spp. Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.

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

Открытое

Основная цель

Диагностика

Центры проведения

Канада · 1 центр

• McMaster Children's Hospital — Hamilton

Идентификаторы

NCT: NCT06114888 · HHS-CB 2023-Pernica-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗