Systemic InfectionNCT05841875
Efficacy and Safety of a Protocol Using C-reactive Protein to Guide Antibiotic Therapy
A study testing C reactive protein algorithm in people with Systemic Infection, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Infection
- What is being tested?
- C reactive protein algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Apr 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100
About this study
Official title: 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
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.
Read the detailed description
The research team will perform a randomized, controlled, concurrent, open, single-center clinical trial. The proposed intervention is the application of a protocol that uses clinical variables and the CRP value to guide the duration of antibiotic therapy in patients with suspected or confirmed bacterial infection. As for the control group, the duration of antibiotic therapy will be suggested according to the best available evidence, considering the primary site of infection and other characteristics of this process. For both groups, the study protocol will be applied through a digital application for use on smartphones or tablets, developed specifically for this project. Participants will be adults admitted to the internal medicine ward of the Hospital das Clínicas of the Federal University of Minas Gerais (HC-UFMG), for whom the assistant physician team has started antibiotic therapy in the last 72 hours. Patients will be allocated after signing a free and informed consent form. Follow-up will be carried out until hospital discharge, death or 90 days, whichever occurs first. The project was submitted for consideration to the Research Ethics Committee of the Federal University of Minas Gerais (COEP-UFMG) and approved. As primary outcome, the duration of antibiotic therapy will be evaluated for the infectious episode that motivated inclusion in the study. Duration of antibiotic therapy will be measured by antimicrobial days (defined by the aggregate of days a specific antimicrobial agent was administered to an individual patient) per 1000 present days (defined by the length of time during which a given patient is at risk for antimicrobial exposure at a given institution). As secondary outcomes, the investigators will assess total exposure to antimicrobials, antibiotic-free days, user satisfaction after using the digital tool, protocol adherence rate, length of stay, estimated cost of antimicrobial therapy, all-cause hospital mortality, therapeutic failure, reinfection rate, subsequent infections with multidrug-resistant microorganisms, Clostridioides difficile infection.
- Conditions
- Systemic Infection
- Being tested
- C reactive protein algorithm
- Keywords
- Systemic infection, Sepsis, Biomarkers, C reactive protein, Antibiotic, Antibiotic stewardship
- Medical subject headings
- Toxemia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C reactive protein algorithmOther
Antibiotic therapy discontinuation will be encouraged under the following conditions:
If the peak CRP is below 100 mg/L: Consider stopping antibiotics when CRP falls below 35 mg/L, with a minimum treatment duration of 3 days.
If the peak CRP is above 100 mg/L or the patient meets criteria for sepsis or septic shock: Consider stopping antibiotics when CRP has decreased by 50%, after a minimum of 5 days.
If the patient does not meet the CRP criteria: Antibiotic discontinuation will be recommended after 5-7 days, provided there is clinical improvement.
Before discontinuing antibiotic therapy, physicians should confirm that the patient is clinically improving, with no signs of a persistent infectious focus. Additionally, they will be encouraged to verify that the Sequential Organ Failure Assessment (SOFA) score is stable or decreasing. These factors will assist in determining the appropriateness of stopping antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - C reactive protein | Experimental | For patients in the intervention group, attending physicians will be encouraged to follow an algorithm that uses clinical variables and serum CRP levels to guide the duration of antibiotic therapy. The peak CRP is defined as the highest value recorded within the first 72 hours of treatment.
Antibiotic therapy discontinuation will be encouraged under the following conditions:
If the peak CRP is below 100 mg/L: Consider stopping antibiotics when CRP falls below 35 mg/L, with a minimum treatment duration of 3 days.
If the peak CRP is above 100 mg/L or the patient meets criteria for sepsis or septic shock: Consider stopping antibiotics when CRP has decreased by 50%, after a minimum of 5 days.
If the patient does not meet the CRP criteria: Antibiotic discontinuation will be recommended after 5-7 days, provided there is clinical improvement. Receives: Other: C reactive protein algorithm |
| Control group: Best practice | No intervention | For patients in the control group, the attending physician will be encouraged to determine the duration of antimicrobial therapy based on the best available evidence, taking into account the most likely infectious focus and the patient's clinical response. These recommendations will be guided by international society guidelines and established best practices for antibiotic therapy. Additionally, it is recommended that CRP monitoring in the control group be discontinued after 72 hours of antibiotic therapy, as this period is considered sufficient for using CRP as a biomarker to assist in diagnosing the infectious condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic therapy
Duration of antibiotic therapy for the index infectious episode (the one that prompted inclusion in the study), measured in days.
Measured: From enrollment to the end of treatment.
Secondary outcomes (10)
Total exposure to antimicrobials
Total antimicrobial exposure, defined as the number of days of antibiotic exposure considering all therapeutic cycles during patient follow-up, measured in Antimicrobial days / days of follow-up x 1,000. Antimicrobial days = total number of days antibiotics were given. If a patient is on 2 antibiotics, both are counted (i.e., the number of days for both drugs are added together). Days of follow-up = sum of days of follow-up in the study.
Measured: 90 days
Antibiotic-free days
Defined by the ratio of the number of days of follow-up without the use of antibiotics by the number of days of follow-up in total, corrected by a denominator of 100.
Measured: 90 days
Length of hospital stay
Measured in days.
Measured: 90 days
Cost estimate of antimicrobial therapy.
Considering Brazilian market prices.
Measured: 2 years
Adherence rate to the protocol in both the intervention and control groups.
The research team will closely monitor the daily progress of patients in each group, and will actively encourage adherence to the protocol associated with the respective group. For the intervention group, this may involve explaining the benefits of following the new algorithm, while for the control group, it may focus on adherence to the standard care. Any deviations from the algorithm will be noted for analysis.
Measured: 90 days
All-cause 90 days mortality
All-cause 90 days mortality.
Measured: 90 days
Therapeutic failure
Defined as persistence or recurrence of signs and symptoms of the same focus of infection that motivates resumption of antibiotic therapy in less than 48 hours after suspension.
Measured: 2 days
Reinfection rate
Defined as a new episode of infection with a different focus or with isolation of new microorganisms or after 48 hours of discontinuation of antibiotic therapy directed at the initial infectious condition.
Measured: 90 days
Subsequent infections by multidrug-resistant microorganisms
Measured by the ratio of cultured isolates per 100 patients.
Measured: 90 days
Clostridioides difficile infection
Measured by diagnostic methods avaiable in Hospital das Clínicas da Universidade Federal de Minas Gerais.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start3 Apr 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais
- Responsible party
- Principal investigator, Vandack Alencar Nobre, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841875
- Sponsor's protocol ID
- BIO.RAP
- Status last verified
- Jul 2025
- First submitted
- 28 Mar 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The project will collect individual clinical and laboratory data from 200 patients, extracted from electronic medical records via the Aplicativo de Gestão para Hospitais Universitários (AGHU, 2009) and laboratory results from the MatrixNet system (MATRIXSAUDE, 2020). In addition, 3 to 5 serum aliquots of 0.5 ml each will be collected from each patient after informed consent is obtained. These aliquots will be stored for potential future analyses by the research team. Clinical and laboratory data will be securely stored using the Research Electronic Data Capture (REDCap) platform (Vanderbilt University, Nashville, USA, 2004). The serum samples will be preserved in a -80°C freezer in a biorepository that complies with the Institutional Biorepository Regulations. The biorepository will be housed at the School of Medicine, Federal University of Minas Gerais (UFMG), located at Av. Prof. Alfredo Balena, 190, Belo Horizonte - MG, CEP 30130-100.
Publications
Borges I, Carneiro R, Bergo R, Martins L, Colosimo E, Oliveira C, Saturnino S, Andrade MV, Ravetti C, Nobre V; NIIMI - Nucleo Interdisciplinar de Investigacao em Medicina Intensiva. Duration of antibiotic therapy in critically ill patients: a randomized controlled trial of a clinical and C-reactive protein-based protocol versus an evidence-based best practice strategy without biomarkers. Crit Care. 2020 Jun 1;24(1):281. doi: 10.1186/s13054-020-02946-y.
PubMed 32487263Rezende VMLR, Borges IN, Ravetti CG, De Souza RP, Vassalo PF, Caldas ACP, Gatto FR, Okamura GH, Lacerda RLB, Povoa PR, Nobre V. 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. BMJ Open. 2025 Jan 27;15(1):e084981. doi: 10.1136/bmjopen-2024-084981.
PubMed 39870501
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05841875
- Acronym / sponsor ID
- BIO.RAP
- Conditions
- Systemic Infection
- Keywords
- Systemic infection, Sepsis, Biomarkers, C reactive protein, Antibiotic, Antibiotic stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research team will perform a randomized, controlled, concurrent, open, single-center clinical trial. The proposed intervention is the application of a protocol that uses clinical variables and the CRP value to guide the duration of antibiotic therapy in patients with suspected or confirmed bacterial infection. As for the control group, the duration of antibiotic therapy will be suggested according to the best available evidence, considering the primary site of infection and other characteristics of this process. For both groups, the study protocol will be applied through a digital application for use on smartphones or tablets, developed specifically for this project. Participants will be adults admitted to the internal medicine ward of the Hospital das Clínicas of the Federal University of Minas Gerais (HC-UFMG), for whom the assistant physician team has started antibiotic therapy in the last 72 hours. Patients will be allocated after signing a free and informed consent form. Follow-up will be carried out until hospital discharge, death or 90 days, whichever occurs first. The project was submitted for consideration to the Research Ethics Committee of the Federal University of Minas Gerais (COEP-UFMG) and approved. As primary outcome, the duration of antibiotic therapy will be evaluated for the infectious episode that motivated inclusion in the study. Duration of antibiotic therapy will be measured by antimicrobial days (defined by the aggregate of days a specific antimicrobial agent was administered to an individual patient) per 1000 present days (defined by the length of time during which a given patient is at risk for antimicrobial exposure at a given institution). As secondary outcomes, the investigators will assess total exposure to antimicrobials, antibiotic-free days, user satisfaction after using the digital tool, protocol adherence rate, length of stay, estimated cost of antimicrobial therapy, all-cause hospital mortality, therapeutic failure, reinfection rate, subsequent infections with multidrug-resistant microorganisms, Clostridioides difficile infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention group - C reactive protein | Experimental | Other: C reactive protein algorithmFor patients in the intervention group, attending physicians will be encouraged to follow an algorithm that uses clinical variables and serum CRP levels to guide the duration of antibiotic therapy. The peak CRP is defined as the highest value recorded within the first 72 hours of treatment. Antibiotic therapy discontinuation will be encouraged under the following conditions: If the peak CRP is below 100 mg/L: Consider stopping antibiotics when CRP falls below 35 mg/L, with a minimum treatment duration of 3 days. If the peak CRP is above 100 mg/L or the patient meets criteria for sepsis or septic shock: Consider stopping antibiotics when CRP has decreased by 50%, after a minimum of 5 days. If the patient does not meet the CRP criteria: Antibiotic discontinuation will be recommended after 5-7 days, provided there is clinical improvement. |
| Control group: Best practice | No intervention | –For patients in the control group, the attending physician will be encouraged to determine the duration of antimicrobial therapy based on the best available evidence, taking into account the most likely infectious focus and the patient's clinical response. These recommendations will be guided by international society guidelines and established best practices for antibiotic therapy. Additionally, it is recommended that CRP monitoring in the control group be discontinued after 72 hours of antibiotic therapy, as this period is considered sufficient for using CRP as a biomarker to assist in diagnosing the infectious condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C reactive protein algorithmAntibiotic therapy discontinuation will be encouraged under the following conditions: If the peak CRP is below 100 mg/L: Consider stopping antibiotics when CRP falls below 35 mg/L, with a minimum treatment duration of 3 days. If the peak CRP is above 100 mg/L or the patient meets criteria for sepsis or septic shock: Consider stopping antibiotics when CRP has decreased by 50%, after a minimum of 5 days. If the patient does not meet the CRP criteria: Antibiotic discontinuation will be recommended after 5-7 days, provided there is clinical improvement. Before discontinuing antibiotic therapy, physicians should confirm that the patient is clinically improving, with no signs of a persistent infectious focus. Additionally, they will be encouraged to verify that the Sequential Organ Failure Assessment (SOFA) score is stable or decreasing. These factors will assist in determining the appropriateness of stopping antibiotics. | Other | Intervention group - C reactive protein |
Primary outcome
Duration of antibiotic therapy
Time frame: From enrollment to the end of treatment.
Duration of antibiotic therapy for the index infectious episode (the one that prompted inclusion in the study), measured in days.
10 secondary outcomes
Total exposure to antimicrobials
Time frame: 90 days
Antibiotic-free days
Time frame: 90 days
Length of hospital stay
Time frame: 90 days
Cost estimate of antimicrobial therapy.
Time frame: 2 years
Adherence rate to the protocol in both the intervention and control groups.
Time frame: 90 days
All-cause 90 days mortality
Time frame: 90 days
Therapeutic failure
Time frame: 2 days
Reinfection rate
Time frame: 90 days
Subsequent infections by multidrug-resistant microorganisms
Time frame: 90 days
Clostridioides difficile infection
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 32487263Borges I, Carneiro R, Bergo R, Martins L, Colosimo E, Oliveira C, Saturnino S, Andrade MV, Ravetti C, Nobre V; NIIMI - Nucleo Interdisciplinar de Investigacao em Medicina Intensiva. Duration of antibiotic therapy in critically ill patients: a randomized controlled trial of a clinical and C-reactive protein-based protocol versus an evidence-based best practice strategy without biomarkers. Crit Care. 2020 Jun 1;24(1):281. doi: 10.1186/s13054-020-02946-y.
- Derived from this study: PubMed 39870501Rezende VMLR, Borges IN, Ravetti CG, De Souza RP, Vassalo PF, Caldas ACP, Gatto FR, Okamura GH, Lacerda RLB, Povoa PR, Nobre V. 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. BMJ Open. 2025 Jan 27;15(1):e084981. doi: 10.1136/bmjopen-2024-084981.
- Individual participant dataSharing planned: Yes. The project will collect individual clinical and laboratory data from 200 patients, extracted from electronic medical records via the Aplicativo de Gestão para Hospitais Universitários (AGHU, 2009) and laboratory results from the MatrixNet system (MATRIXSAUDE, 2020). In addition, 3 to 5 serum aliquots of 0.5 ml each will be collected from each patient after informed consent is obtained. These aliquots will be stored for potential future analyses by the research team. Clinical and laboratory data will be securely stored using the Research Electronic Data Capture (REDCap) platform (Vanderbilt University, Nashville, USA, 2004). The serum samples will be preserved in a -80°C freezer in a biorepository that complies with the Institutional Biorepository Regulations. The biorepository will be housed at the School of Medicine, Federal University of Minas Gerais (UFMG), located at Av. Prof. Alfredo Balena, 190, Belo Horizonte - MG, CEP 30130-100.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C reactive protein algorithm in people with Systemic Infection, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of antibiotic therapy (time frame: From enrollment to the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05841875, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.