Back to resultsUse of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults (PROCALBAN)
Primary Purpose
Sepsis
Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Procalcitonin measurement
Sponsored by
About this trial
This is an interventional health services research trial for Sepsis
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
Sites / Locations
- Chattogram Medical College Hospital (CMCH)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Daily measurement of serum procalcitonin concentrations
Standard of practice (routine clinical care)
Arm Description
Outcomes
Primary Outcome Measures
Length of antibiotic treatment
number of days of antibiotic treatment during the hospitalisation period.
Secondary Outcome Measures
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.
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.
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
Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.
Recurrent infections include culture positive relapse (failure of initial eradicative treatment for the original infecting strain), culture negative relapse (recurrence of initial symptoms within 2 days of stopping antibiotics) and reinfection (infection with a different strain of the same species). Recurrent infections are defined as growth of one or more of the initial causative bacterial strains (i.e., same genus, species) from a second sample taken from the same infection site after stopping of antibiotic therapy, combined with clinical signs and symptoms of infection. Superinfection is defined as the isolation from the same or another site of one or more pathogens different from that identified during the first infectious episode, together with clinical signs or symptoms of infection.
Duration of hospital stay (ICU/ general ward)
Proportion of patients with infections caused by antibiotic resistant bacteria
Direct medical costs of prescribed antibiotics, the assessment of serum procalcitonin (PCT assay) and hospital stay cost.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05955612
Brief Title
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Acronym
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 Randomised, Controlled, Open-label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Procalcitonin measurements.
Allocation
Randomized
Enrollment
532 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Daily measurement of serum procalcitonin concentrations
Arm Type
Experimental
Arm Title
Standard of practice (routine clinical care)
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Procalcitonin measurement
Intervention Description
Daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics
Primary Outcome Measure Information:
Title
Length of antibiotic treatment
Description
number of days of antibiotic treatment during the hospitalisation period.
Time Frame
Through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Consumption of antibiotics expressed as the Defined Daily Dosage (DDD)
Description
Defined daily dose (DDD) is the assumed average maintenance dose per day for a drug used in its main indication in adults.
Time Frame
Through study completion, an average of 1 month
Title
Days of therapy with antibiotics (DOT)
Description
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.
Time Frame
Through study completion, an average of 1 month
Title
Number of days of parenteral antibiotic during hospitalisation period
Description
Number of days of parenteral antibiotic from the day of enrolment to the day of stopping of parenteral antibiotic during hospitalisation period
Time Frame
Through study completion, an average of 1 month
Title
Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.
Description
Recurrent infections include culture positive relapse (failure of initial eradicative treatment for the original infecting strain), culture negative relapse (recurrence of initial symptoms within 2 days of stopping antibiotics) and reinfection (infection with a different strain of the same species). Recurrent infections are defined as growth of one or more of the initial causative bacterial strains (i.e., same genus, species) from a second sample taken from the same infection site after stopping of antibiotic therapy, combined with clinical signs and symptoms of infection. Superinfection is defined as the isolation from the same or another site of one or more pathogens different from that identified during the first infectious episode, together with clinical signs or symptoms of infection.
Time Frame
Through study completion, an average of 1 month
Title
Duration of hospital stay (ICU/ general ward)
Time Frame
Through study completion, an average of 1 month
Title
Proportion of patients with infections caused by antibiotic resistant bacteria
Time Frame
Through study completion, an average of 1 month
Title
Direct medical costs of prescribed antibiotics, the assessment of serum procalcitonin (PCT assay) and hospital stay cost.
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Forhad Uddin Hasan Chowdhury, MBBS, FCPS, MSc
Phone
+8801712101875
Email
forhad.chowdhury@ndm.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Plewes, MD
Phone
+1-604-603-4033
Email
Katherine@tropmedres.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arjen Dondorp, Professor
Organizational Affiliation
Mahidol Oxford Tropical Medicine Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chattogram Medical College Hospital (CMCH)
City
Chittagong
State/Province
Chattogram
ZIP/Postal Code
4203
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aniruddha Ghose, Dr
Email
anrdghs@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant data and results from blood analyses stored in the database may be shared according to the terms defined in the Mahidol Oxford Tropical Medicine Research Unit (MORU) data sharing policy with other researchers to use in the future. Datasets will be de-identified to ensure patient privacy and confidentiality.
Learn more about this trial
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
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