Using C-reactive Protein to Guide Antibiotic Treatment

Efficacy and Safety of a Protocol Using C-reactive Protein to Guide Antibiotic Therapy Applied Through a Digital Clinical Decision Support Tool: a Randomized Clinical Trial

This study is testing if using C-reactive protein levels to guide how long people with bacterial infections take antibiotics can help reduce unnecessary use while still treating their infections effectively.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Federal University of Minas Gerais (other)
• Drugs / interventions: rituximab, chemotherapy, cyclophosphamide, prednisone
• Locations: 1 site (Belo Horizonte, Minas Gerais)
• Trial ID: NCT05841875 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a protocol that utilizes C-reactive protein (CRP) levels and clinical variables to determine the duration of antibiotic therapy in patients with suspected or confirmed bacterial infections. Participants will be randomly assigned to either the CRP-guided group or a control group receiving standard treatment based on existing guidelines. The intervention will be facilitated through a specially developed digital application for smartphones or tablets. The study aims to reduce unnecessary antibiotic exposure while ensuring effective treatment of infections.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a clinical suspicion or microbiological confirmation of bacterial infection who have started antibiotic therapy within the last 72 hours.

Not a fit: Patients with severe immunosuppression, such as those with HIV and low CD4 counts or recent chemotherapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized antibiotic therapy, reducing unnecessary antibiotic use and combating resistance.

How similar studies have performed: Previous studies using biomarkers like procalcitonin have shown promise in guiding antibiotic therapy, suggesting potential success for this novel approach with CRP.

Eligibility criteria

Inclusion Criteria:

* Patients over 18 years of age,
* Clinical suspicion or microbiological confirmation of bacterial infection, with initiation of antibiotic therapy in the last 72 hours.
* Signing of the free and informed consent term by the patient or companion if the patient is unable to sign it (Annex 1).
* Patient admitted to the unit participating in the study.

Exclusion Criteria:

* HIV-infected patients with a CD4 count \< 200 cells/mm3; neutropenic with neutrophil count \< 500 cells/mm3; solid organ or bone marrow transplants; patients who received chemotherapy in the last 14 days at high risk of febrile neutropenia (\> 20%), defined by the assistant team responsible for the treatment of the neoplasm; use of immunosuppressants, such as cyclophosphamide, azathioprine, cyclosporine, rituximab, tacrolimus, sirolimus or TNF inhibitors; use of corticosteroid therapy at a dose greater than 0.5mg/Kg of prednisone (or equivalent) over the last 30 days or pulse therapy in the last 14 days with these drugs; primary immunodeficiency (eg, X-linked agammaglobulinemia, common variable immunodeficiency) or patients with another condition that determines a clear impairment of immunological defenses, whether humoral, cellular or mixed.
* Conditions that require prolonged antibiotic therapy (infective endocarditis, necrotizing pneumonia, deep abscesses, osteomyelitis, complicated soft tissue infections, S. aureus bacteremia, among others), identified before randomization (ie, up to 72 hours of antibiotic therapy) .
* Patients with the perspective of hospital discharge in less than 72 hours from inclusion.
* Patients in exclusive palliative care.
* Patients with life expectancy \< 24h.

Where this trial is running

Belo Horizonte, Minas Gerais

• Hospital das Clínicas da Universidade Federal de Minas Gerais — Belo Horizonte, Minas Gerais, Brazil (RECRUITING)

Study contacts

• Study coordinator: Vitoria Rezende, Post graduate student

Conditions: Systemic Infection, Systemic infection, Sepsis, Biomarkers, C reactive protein, Antibiotic, Antibiotic stewardship