NCT05841875

Efficacy and Safety of a Protocol Using C-reactive Protein to Guide Antibiotic Therapy

Completed NA Last updated 12 August 2025

What this trial tests

NA trial testing C reactive protein algorithm in Systemic Infection in 110 participants. Completed in 30 October 2024.

Timeline

3 April 2023

Primary endpoint
30 October 2024

30 October 2024

Quick facts

Lead sponsor	Federal University of Minas Gerais
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	3 April 2023
Primary completion	30 October 2024
Estimated completion	30 October 2024
Sites	1 location across Brazil

Drugs / interventions tested

• C reactive protein algorithm

Conditions studied

• Systemic Infection — all drugs for Systemic Infection →

Sponsor

Federal University of Minas Gerais

Who can join

18 and older, any sex, with Systemic Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The growing resistance of microorganisms to antimicrobials is a major threat to public health nowadays. Reducing the consumption of antibiotics is one of the main strategies to control this issue. Protocols using biomarkers to guide antimicrobial therapy have been studied, with promising results in safely reducing patient exposure to these drugs by reducing duration of treatments. Procalcitonin (PCT) and C-reactive protein (CRP) represent the most promising biomarkers in this context. Although less studied, CRP has the potential advantages of lower cost and wide availability when compared to PCT. However, decision algorithms involving biomarkers proposed in studies published so far are very far from daily medical practice in hospitals, mainly because there is poor accessibility to these protocols, and because most of them do not contemplate each patients clinical variables. The objective of this project is to evaluate the efficacy and safety of a multimodal protocol using clinical variables and the CRP value to guide antibiotic therapy in hospitalized patients. This protocol will be applied diretcly by the assistant medical teams through a digital clinical decision support tool available in the form of an application for mobile devices developed by the research team.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. When to Stop Antibiotics in the Critically Ill?
   Nielsen ND, Dean JT, Shald EA, Conway Morris A, et al · · 2024 · cited 10× · PMID 38534707 · DOI 10.3390/antibiotics13030272
2. Biomarkers to guide sepsis management.
   Bourika V, Rekoumi EA, Giamarellos-Bourboulis EJ. · · 2025 · cited 5× · PMID 40685448 · DOI 10.1186/s13613-025-01524-1
3. 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.
   Rezende VMLR, Borges IN, Ravetti CG, De Souza RP, et al · · 2025 · cited 1× · PMID 39870501 · DOI 10.1136/bmjopen-2024-084981