Use of Procalcitonin Point-of-care Test to Guide De-escalation of Empiric Antibiotic Therapy in Adult Patients With Sepsis in a Tertiary Hospital in Bangladesh (PROCALBAN): a Phase 3 Randomised, Controlled, Open-label Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 2
- 主要终点
- Length of antibiotic treatment
研究概览
简要总结
Trial design:
Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with sepsis.
Trial settings Trial site is Chattogram Medical College Hospital (CMCH), Bangladesh. CMCH is tertiary care hospital with undergraduate and postgraduate teaching facilities. This tertiary hospital receives referrals from urban and rural areas of southern Bangladesh and has basic facilities for intensive care and haemodialysis.
Trial Participants:
Male or female hospitalised patients, 16-65 years of age, with confirmed or suspected sepsis Patients (Total 532) will be 1:1 randomised to either:
- Intervention arm: daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics (Intervention arm: 266), or
- Control arm: standard of practice to guide de-escalation of antibiotics without procalcitonin assessments (Control arm: 266).
Patients will be followed-up until ICU discharge and/or hospital discharge with an additional follow-up at 28 days after discharge.
Funder: Wellcome Trust of Great Britain
Grant reference number from Wellcome Trust: 220211/A/20/Z
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Procalcitonin measurements.
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant, legally authorised person/ legal guardian willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 16 to 65 years
- •Suspected or proven bacterial infection
- •A positive sepsis screening National Early Warning Score (NEWS) equal or greater than 5 (Table 1 or at least one criterion with a score of
- •Intention to start parenteral antibiotic therapy
- •Within 24 hours of hospital admission
排除标准
- •Patients with suspected/documented tuberculosis, parasitic infection (including malaria or visceral leishmaniasis), or viral infections (i.e., COVID-19, dengue, HIV)
- •Pregnancy
- •Intended for a short stay in ICU or general ward (such as post-operative)
- •Patients requiring a predefined long course of antibiotic therapy (such as endocarditis, osteomyelitis, lung abscess, liver abscess, septic arthritis)
- •Immunocompromised patients, including as severe neutropenia (< 500 cells/ml), transplant recipients, on prolonged corticosteroid treatment, chemotherapy or disease modifying immunomodulatory medications
- •More than 48 hours of parenteral antibiotic use
- •Surgical patients, including patients with a surgical septic source or patients requiring source control, i.e. abscess drainage
- •Moribund patients or patients receiving end of life care
- •Previous enrolment in PROCALBAN
- •Conditions accompanied with a systemic inflammatory state, including pancreatitis, cardiogenic shock, severe trauma
结局指标
主要结局
Length of antibiotic treatment
时间窗: Through study completion, an average of 1 month
number of days of antibiotic treatment during the study period.
次要结局
- Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.(Through study completion, an average of 1 month)
- Proportion of patients with infections caused by antibiotic resistant bacteria(Through study completion, an average of 1 month)
- Consumption of antibiotics expressed as the Defined Daily Dosage (DDD)(Through study completion, an average of 1 month)
- Days of therapy with antibiotics (DOT)(Through study completion, an average of 1 month)
- Number of days of parenteral antibiotic during hospitalisation period(Through study completion, an average of 1 month)
- Number of days of antibiotic treatment during the hospitalisation period.(Through study completion, an average of 1 month)
- Duration of hospital stay (ICU/ general ward)(Through study completion, an average of 1 month)
- Direct medical costs of prescribed antibiotics, the assessment of serum procalcitonin (PCT assay) and hospital stay cost.(Through study completion, an average of 1 month)