- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955612
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults (PROCALBAN)
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
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
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Forhad Uddin Hasan Chowdhury, MBBS, FCPS, MSc
- Phone Number: +8801712101875
- Email: forhad.chowdhury@ndm.ox.ac.uk
Study Contact Backup
- Name: Katherine Plewes, MD
- Phone Number: +1-604-603-4033
- Email: Katherine@tropmedres.ac
Study Locations
-
-
Chattogram
-
Chittagong, Chattogram, Bangladesh, 4203
- Recruiting
- Chattogram Medical College Hospital (CMCH)
-
Contact:
- Aniruddha Ghose, Dr
- Email: anrdghs@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daily measurement of serum procalcitonin concentrations
|
Daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics
|
No Intervention: Standard of practice (routine clinical care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of antibiotic treatment
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consumption of antibiotics expressed as the Defined Daily Dosage (DDD)
Time Frame: Through study completion, an average of 1 month
|
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
|
Days of therapy with antibiotics (DOT)
Time Frame: Through study completion, an average of 1 month
|
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
|
Number of days of parenteral antibiotic during hospitalisation period
Time Frame: Through study completion, an average of 1 month
|
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
|
Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.
Time Frame: Through study completion, an average of 1 month
|
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.
|
Through study completion, an average of 1 month
|
Duration of hospital stay (ICU/ general ward)
Time Frame: Through study completion, an average of 1 month
|
Through study completion, an average of 1 month
|
|
Proportion of patients with infections caused by antibiotic resistant bacteria
Time Frame: Through study completion, an average of 1 month
|
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.
Time Frame: Through study completion, an average of 1 month
|
Through study completion, an average of 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arjen Dondorp, Professor, Mahidol Oxford Tropical Medicine Research Unit
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAC23002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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