Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults

Sepsis Clinical Trial

— PROCALBAN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955612
• Other study ID #: BAC23002
• Status: Recruiting
• Phase: Phase 3
• Start date: July 26, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Oxford
• Contact: Forhad Uddin Hasan Chowdhury, MBBS, FCPS, MSc
• Phone: +8801712101875
• Email: forhad.chowdhury[@]ndm.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 532
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Procedure:
• Procalcitonin measurement
Daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics

Locations

Country	Name	City	State
Bangladesh	Chattogram Medical College Hospital (CMCH)	Chittagong	Chattogram

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of antibiotic treatment	number of days of antibiotic treatment during the study period.	Through study completion, an average of 1 month
Secondary	Consumption of antibiotics expressed as the Defined Daily Dosage (DDD)	Defined daily dose (DDD) is the assumed average maintenance dose per day for a drug used in its main indication in adults.	Through study completion, an average of 1 month
Secondary	Days of therapy with antibiotics (DOT)	Definition of DOT: One DOT represents the administration of a single antibiotic on a given day regardless of the number of doses administered or dosage strength. If a patient receives more than one antibiotic it will be added on with DOT of the first antibiotic.	Through study completion, an average of 1 month
Secondary	Number of days of parenteral antibiotic during hospitalisation period	Number of days of parenteral antibiotic from the day of enrolment to the day of stopping of parenteral antibiotic during hospitalisation period	Through study completion, an average of 1 month
Secondary	Number of days of antibiotic treatment during the hospitalisation period.		Through study completion, an average of 1 month
Secondary	Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.	Recurrent infections are classified as follows: culture-positive relapse (unsuccessful eradication of the original infecting strain), culture-negative relapse (reappearance of symptoms after antibiotics cessation with negative cultures), reinfection (infection by a different strain of the same species), and syndromic recurrence (symptoms recur post-antibiotics, regardless of culture results).	Through study completion, an average of 1 month
Secondary	Duration of hospital stay (ICU/ general ward)		Through study completion, an average of 1 month
Secondary	Proportion of patients with infections caused by antibiotic resistant bacteria		Through study completion, an average of 1 month
Secondary	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