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Completed

NCT Number: NCT05955612

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

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chattogram Medical College Hospital (CMCH)

Chittagong, Chattogram, 4203, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procalcitonin measurement

Procedure

Daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics

Primary outcomes

  1. Length of antibiotic treatment

    Time frame: Through study completion, an average of 1 month

    number of days of antibiotic treatment during the study period.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Number of days of antibiotic treatment during the hospitalisation period.

    Time frame: Through study completion, an average of 1 month

  5. Overall mortality, mortality associated with recurrent infection and non-lethal recurrent infections.

    Time frame: Through study completion, an average of 1 month

    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).

  6. Duration of hospital stay (ICU/ general ward)

    Time frame: Through study completion, an average of 1 month

  7. Proportion of patients with infections caused by antibiotic resistant bacteria

    Time frame: Through study completion, an average of 1 month

  8. 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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Acronym: PROCALBAN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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