Clinical trial NCT05955612: Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 532
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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 3.
* Intention to start parenteral antibiotic therapy
* Within 24 hours of hospital admission

Exclusion Criteria:

* 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

Primary outcomes:
measure: Length of antibiotic treatment
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Consumption of antibiotics expressed as the Defined Daily Dosage (DDD)
timeFrame: Through study completion, an average of 1 month
measure: Days of therapy with antibiotics (DOT)
timeFrame: Through study completion, an average of 1 month
measure: Number of days of parenteral antibiotic during hospitalisation period
timeFrame: Through study completion, an average of 1 month
measure: Number of days of antibiotic treatment during the hospitalisation period.
timeFrame: Through study completion, an average of 1 month
measure: Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.
timeFrame: Through study completion, an average of 1 month
measure: Duration of hospital stay (ICU/ general ward)
timeFrame: Through study completion, an average of 1 month
measure: Proportion of patients with infections caused by antibiotic resistant bacteria
timeFrame: Through study completion, an average of 1 month
measure: Direct medical costs of prescribed antibiotics, the assessment of serum procalcitonin (PCT assay) and hospital stay cost.
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chattogram Medical College Hospital (CMCH)
state: Chattogram
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Arjen Dondorp, Professor
role: PRINCIPAL_INVESTIGATOR
References: