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

NCT05955612 | Completed Phase 3 DMC

• 1 other identifier: BAC23002
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Length of antibiotic treatment

  number of days of antibiotic treatment during the study period.

  Through study completion, an average of 1 month

Secondary Outcomes (8)

• Consumption of antibiotics expressed as the Defined Daily Dosage (DDD)

  Through study completion, an average of 1 month

• Days of therapy with antibiotics (DOT)

  Through study completion, an average of 1 month

• Number of days of parenteral antibiotic during hospitalisation period

  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

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

  Through study completion, an average of 1 month

Study Arms (2)

Daily measurement of serum procalcitonin concentrations

EXPERIMENTAL

Procedure: Procalcitonin measurement

Standard of practice (routine clinical care)

NO INTERVENTION

Interventions

Procalcitonin measurement PROCEDURE

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

Daily measurement of serum procalcitonin concentrations

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Chattogram Medical College Hospital (CMCH)

Chittagong, Chattogram, 4203, Bangladesh

Location

MeSH Terms

Conditions

Sepsis

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Officials

• Arjen Dondorp, Professor

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Procalcitonin measurements.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 21, 2023
• Study Start: July 26, 2023
• Primary Completion: June 20, 2024
• Study Completion: July 30, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

BA (1)