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. 2025 Jan 27;15(1):e084981.
doi: 10.1136/bmjopen-2024-084981.

Efficacy and safety of an algorithm using C-reactive protein to guide antibiotic therapy applied through a digital clinical decision support system: a study protocol for a randomised controlled clinical trial

Vitoria Moura Leite Rabelo Rezende  1 , Isabela Nascimento Borges  2 , Cecilia Gomez Ravetti  2 , Renan Pedra De Souza  2 , Paula Frizera Vassalo  2 , Ana Clara de Paula Caldas  2 , Felipe Rodrigues Gatto  2 , Getulio Hideyoshi Okamura  2 , Raquel Lopes de Brito Lacerda  2 , Pedro R Povoa  3 , Vandack Nobre  2
Affiliations

Efficacy and safety of an algorithm using C-reactive protein to guide antibiotic therapy applied through a digital clinical decision support system: a study protocol for a randomised controlled clinical trial

Vitoria Moura Leite Rabelo Rezende et al. BMJ Open. .

Abstract

Introduction: The escalating resistance of microorganisms to antimicrobials poses a significant public health threat. Strategies that use biomarkers to guide antimicrobial therapy-most notably Procalcitonin (PCT) and C-reactive protein (CRP)-show promise in safely reducing patient antibiotic exposure. While CRP is less studied, it offers advantages such as lower cost and broader availability compared with PCT.

Methods and analysis: This randomised clinical trial aims to evaluate a novel algorithm for non-critically ill adult patients. The algorithm incorporates key clinical variables and CRP behaviour. It will be applied through a mobile application as a digital clinical decision support system. The primary goal will be to assess the algorithm's effectiveness in reducing treatment duration compared with standard care based on current guidelines, while ensuring patient safety by monitoring the occurrence of adverse events.

Ethics and dissemination: Only patients who agree to participate in the study after reading the informed consent form will be included. This project was submitted for consideration to the Research Ethics Committee of the Federal University of Minas Gerais (COEP-UFMG) and received approval (Approval Number: 5.905.290). Collection of clinical and laboratory data from 200 patients is expected, extracted from electronic medical records and laboratory systems, along with serum samples stored for potential future analyses. Data will be preserved using the Research Electronic Data Capture platform, and serum samples will be stored in a regulated biorepository at UFMG. Access will be controlled via credentials, with privacy protections and anonymisation prior to sharing, which will occur during scientific publications.

Trial registration number: This trial was registered on ClinicalTrials.gov (NCT05841875) and was last updated on 5 December 2024 at 12:49.

Keywords: Anti-Bacterial Agents; Antibiotics; Clinical Decision-Making; GENERAL MEDICINE (see Internal Medicine); Telemedicine; eHealth.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Study protocol. CRP, C-reactive protein; ICF, informed consent Form.
Figure 2
Figure 2. Intervention group algorithm. Peak CRP value was defined as the highest value within the first 72 hours of antibiotic therapy. Septic shock, defined as persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation. CRP, C-reactive protein; SOFA score, Sequential Organ Failure Assessment score.
Figure 3
Figure 3. Recommendations for control group. Recommended time may vary according to the antimicrobial agent. Patients should show no signs of a persistent infectious focus.
Figure 4
Figure 4. Data used for sample size calculation. CRP, C-reactive protein.
See this image and copyright information in PMC

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