Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01018199
Status:
WITHDRAWN
Last Update Posted:
2016-02-03
First Post:
2009-11-20
Brief Title:
Procalcitonin Versus C-reactive Protein to Guide Therapy in Community Acquired Pneumonia
Sponsor:
Federal University of Minas Gerais
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Use of Procalcitonin PCT and C-reactive Protein CRP to Guide Antibiotic Therapy in Community Acquired Pneumonia a Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changes in the profile of patients assisted by the hospital
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP-Marker
Brief Summary:
In this study the investigators aim to test if C-reactive protein CRP or procalcitoninPCT - 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 physicianPatients 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 123 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 ie 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 25mgdl is reached
3 PCT group a relative reduction of 90 in baseline PCT levels or if a absolute value lower than 01 ngml is reached
The final decision regarding antibiotic therapy will be always let to the discretion of the treating physician
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 physicianPatients 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 123 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 ie 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 25mgdl is reached
3 PCT group a relative reduction of 90 in baseline PCT levels or if a absolute value lower than 01 ngml is reached
The final decision regarding antibiotic therapy will be always let to the discretion of the treating physician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None