SepsisPhase 3PROCALBANNCT05955612
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
A Phase 3 study testing Procalcitonin measurement in people with Sepsis, run by University of Oxford at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Procalcitonin measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 1 siteBangladesh
- Study dates
- 26 Jul 2023to 30 Jul 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Chattogram Medical College Hospital (CMCH)
Chittagong, Chattogram, 4203
About this study
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
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.
Read more
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
- Conditions
- Sepsis
- Being tested
- Procalcitonin measurement
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin measurementProcedure or surgery
Daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Daily measurement of serum procalcitonin concentrations | Experimental | Not described Receives: Procedure: Procalcitonin measurement |
| Standard of practice (routine clinical care) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of antibiotic treatment
number of days of antibiotic treatment during the study period.
Measured: Through study completion, an average of 1 month
Secondary outcomes (8)
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.
Measured: Through study completion, an average of 1 month
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.
Measured: Through study completion, an average of 1 month
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
Measured: Through study completion, an average of 1 month
Number of days of antibiotic treatment during the hospitalisation period.
Measured: Through study completion, an average of 1 month
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).
Measured: Through study completion, an average of 1 month
Duration of hospital stay (ICU/ general ward)
Measured: Through study completion, an average of 1 month
Proportion of patients with infections caused by antibiotic resistant bacteria
Measured: 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.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start26 Jul 2023
- Primary completion20 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjen Dondorp, Professor, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955612
- Sponsor's protocol ID
- BAC23002
- Acronym
- PROCALBAN
- Status last verified
- Sep 2024
- First submitted
- 22 Jun 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Hasan Chowdhury FU, Md Erfan Uddin RA, Ali M, Dutta PK, Das D, Hanif AH, Di Gregorio S, Kar M, Jahangir FB, Khan SI, Chowdhury K, Mohasin M, Sayeed AA, Or Roshid MH, Chy NU, Hossain MA, Sattar MA, Schilstra M, de Jong E, Schultsz C, Nijsten M, Uddin MJ, Ghose A, Plewes K, Pisani L, Guerin P, Mukaka M, Dondorp AM. Use of procalcitonin point-of-care testing to guide de-escalation of antibiotic therapy in adults with suspected bacterial sepsis in a tertiary hospital in Bangladesh: a randomised controlled open-label trial. EClinicalMedicine. 2026 Sep 2;99:104171. doi: 10.1016/j.eclinm.2026.104171. eCollection 2026 Sep.
PubMed 42724645