Suspended

CAP-MarkerUse of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial

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What is being tested

CRP

+ PCT

Other
Who is being recruted

Community-Acquired Pneumonia+3

+ Infections

+ Pneumonia

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2016
See protocol details

Summary

Principal SponsorFederal University of Minas Gerais
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2016

Actual date on which the first participant was enrolled.

Methods • Patients and settings: All adult (> 18 years old) patients with diagnosis community-acquired pneumonia will receive initial antibiotic therapy based on local guidelines and susceptibility patterns, according to the decision of the treating physician.Patients will be randomly assigned to one of two groups, which respectively include PCR and PCT clinical procedure protocol. Randomization will be done using a table of random numbers generated by computer. For practical reasons the doctors treating the patients in question have science group in which the patient was included. Patients included in the two groups will have baseline assessment during the first day of study: * Clinical evaluation of basic * Start of antibiotic therapy * Inclusion in the study * Randomization (after signing the Informed Consent) * Interventions: They will have circulating PCT and CRP levels measured at baseline and days 1,2,3 e 5 in both groups. Group 1 - CRP group: the duration of antibiotic therapy will be based on circulating CRP levels. Group 2 - PCT group: the duration of antibiotic therapy will be based on circulating PCT levels. Patients enrolled in the study will undergo daily measurements of plasma CRP (Dry Chemistry - Johnsons \& Johnsons) and PCT (BRAHMS PCT VIDAS) levels up to day 5, and then, every 48hr in patients remaining in the ICU, and every 5 days in those transferred to the ward. Patients will be followed up 28 days, or until death or hospital transference, which comes first. PCT and CRP results will be released in sealed envelopes. During the study period, only the results corresponding to the patient randomization group will be open; i.e., CRP for CRP group patients and PCT for PCT group patients. Criteria for antibiotic interruption: The investigators will propose the interruption of antibiotics if: 1. The patients is clinically stable, without signs of active infection 2. CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached. 3. PCT group: a relative reduction of 90% in baseline PCT levels, or if a absolute value lower than 0.1 ng/ml is reached. The final decision regarding antibiotic therapy will be always let to the discretion of the treating physician.

Official TitleUse of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial
NCT01018199
Principal SponsorFederal University of Minas Gerais
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Community-Acquired PneumoniaInfectionsPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsCommunity-Acquired Infections

Criteria

3 inclusion criteria required to participate
Age ≥ 18 years

Signed informed consent

Suspected or confirmed community-acquired pneumonia

9 exclusion criteria prevent from participating
Nosocomial pneumonia: development of symptoms after 48 hours of admission to the Emergency Department, or within 14 days after hospital discharge

Patients with lung cancer confirmed strongly suspected.

Patients with severe immunosuppression, such as severe neutropenia (<500 neutrófilos/mm3), use of corticosteroids in doses above 0.5 mg / kg / day of prednisone or equivalent for at least 2 weeks, transplantation of solid organs or cells hematopoietic, use of immunosuppressants for any other reason (eg. azathioprine or cyclosporine), hipogamagloulinemia

Patients with asplenia in any order

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention on antibiotic therapy will be based on circulating RCP levels

Group II

Active Comparator
Intervention on antibiotic therapy will be based on circulating PCT levels

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, BrazilOpen Hospital das Clínicas - Universidade Federal de Minas Gerais in Google Maps
SuspendedOne Study Center