Community-acquired PneumoniaCAP-MarkerNCT01018199
Procalcitonin Versus C-reactive Protein to Guide Therapy in Community Acquired Pneumonia
A study testing CRP and PCT in people with Community-acquired Pneumonia, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
In this study the investigators aim to test if C-reactive protein (CRP) or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht community-acquired pneumonia. Therefore, the safety of this intervention will be carefully measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- CRP and PCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Aug 2018
- 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
- Age ≥ 18 years
- Signed informed consent
- Suspected or confirmed community-acquired pneumonia
Who cannot join
- 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
- Pregnant
- Patients with known HIV infection
Show all 9Show fewer
- Stay indicated only for social reasons
- Patients on antibiotics for any other reason
- Patients with multiple trauma, burns or surgery grid size in the last 5 days
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais
About this study
Official title: Use of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial
In this study the investigators aim to test if C-reactive protein (CRP) or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht community-acquired pneumonia. Therefore, the safety of this intervention will be carefully measured.
Read the detailed description
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:
- The patients is clinically stable, without signs of active infection
- CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached.
- 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- CRP, PCT
- Keywords
- C-reactive protein, procalcitonin, community-acquired pneumonia, antibiotic therapy
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRPOther
C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy
PCTOther
Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1- C-reactive protein (CRP) guided antibiotic therapy | Experimental | Intervention on antibiotic therapy will be based on circulating RCP levels Receives: Other: CRP |
| Group 2 - procalcitonin (PCT) guided antibiotic therapy | Active comparator | Intervention on antibiotic therapy will be based on circulating PCT levels Receives: Other: PCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of antibiotic therapy for the first episode of infection
Measured: 28 days
Total antibiotic exposure days per 1,000 days
Measured: 28 days
Days alive without antibiotics
Measured: 28 days
Secondary outcomes (10)
All cause 28-day mortality
Measured: 28 days
clinical cure rate
Measured: 28 days
Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
Measured: 28 days
Length of hospitalization stay
Measured: Whole hospitalization
In-hospital mortality
Measured: 28 days
Nosocomial infection rate
Measured: 28 days
Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
Measured: 28 days
Isolation of resistant bacteria
Measured: 28 days
All cause 90-day mortality
Measured: 90 days
costs of hospitalization
Measured: Whole hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startJan 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Changes in the profile of patients assisted by the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vandack Alencar Nobre, Federal University of Minas Gerais
- Investigators
- Vandack A Nobre, PhD, Principal investigator, Medical School of the Federal University of Minas GeraisKarla F Finotti, MD, Study chair, Medical School of the Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018199
- Sponsor's protocol ID
- UFMG-PCT
- Acronym
- CAP-Marker
- Status last verified
- Mar 2012
- First submitted
- 20 Nov 2009
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Procalcitonin (PCT) and C-reactive Protein (CRP) to Guide Antibiotic Therapy in Community Acquired Pneumonia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01018199
- Acronym / sponsor ID
- CAP-Marker / UFMG-PCT
- Conditions
- Community-acquired Pneumonia
- Keywords
- C-reactive protein, procalcitonin, community-acquired pneumonia, antibiotic therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in the profile of patients assisted by the hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- 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.
In this study the investigators aim to test if C-reactive protein (CRP) or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht community-acquired pneumonia. Therefore, the safety of this intervention will be carefully measured.
Detailed description
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:
- The patients is clinically stable, without signs of active infection
- CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- C-reactive protein (CRP) guided antibiotic therapy | Experimental | Other: CRPIntervention on antibiotic therapy will be based on circulating RCP levels |
| Group 2 - procalcitonin (PCT) guided antibiotic therapy | Active comparator | Other: PCTIntervention on antibiotic therapy will be based on circulating PCT levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Signed informed consent
- Suspected or confirmed community-acquired pneumonia
Key exclusion criteria (9 listed)
- 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
- Pregnant
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 |
|---|---|---|
| CRPC-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy | Other | Group 1- C-reactive protein (CRP) guided antibiotic therapy |
| PCTProcalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy | Other | Group 2 - procalcitonin (PCT) guided antibiotic therapy |
Primary outcome
Duration of antibiotic therapy for the first episode of infection
Time frame: 28 days
Total antibiotic exposure days per 1,000 days
Time frame: 28 days
Days alive without antibiotics
Time frame: 28 days
10 secondary outcomes
All cause 28-day mortality
Time frame: 28 days
clinical cure rate
Time frame: 28 days
Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
Time frame: 28 days
Length of hospitalization stay
Time frame: Whole hospitalization
In-hospital mortality
Time frame: 28 days
Nosocomial infection rate
Time frame: 28 days
Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
Time frame: 28 days
Isolation of resistant bacteria
Time frame: 28 days
All cause 90-day mortality
Time frame: 90 days
costs of hospitalization
Time frame: Whole hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Community-acquired Pneumonia
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Pneumonia, Community-Acquired, COVID-19 Pneumonia
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Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
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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.
Vandack A Nobre, PhD principal investigator
Medical School of the Federal University of Minas Gerais
Karla F Finotti, MD study chair
Medical School of the Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP and PCT in people with Community-acquired Pneumonia, 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Feb 2016. 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 was withdrawn before enrolling participants, so there are no results.
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 for the first episode of infection (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2016.