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

NCT ID: NCT05955612

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2024-07-30

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

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Daily measurement of serum procalcitonin concentrations

Group Type: EXPERIMENTAL

Procalcitonin measurement

Intervention Type: PROCEDURE

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

Standard of practice (routine clinical care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Procalcitonin measurement

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arjen Dondorp, Professor

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

Chattogram Medical College Hospital (CMCH)

Chittagong, Chattogram, Bangladesh

Countries

Bangladesh

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BAC23002

Identifier Type: -

Identifier Source: org_study_id