CompletedPhase 3

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

Bangladesh532 participantsStarted 2023-07-26

Plain-language 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

Who can participate

Age range

16 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Length of antibiotic treatment

Timeframe: Through study completion, an average of 1 month

Trial details

NCT IDNCT05955612

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-20

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