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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01018199
Other study ID # UFMG-PCT
Secondary ID
Status Withdrawn
Phase N/A
First received November 20, 2009
Last updated February 1, 2016
Start date January 2016
Est. completion date August 2018

Study information

Verified date March 2012
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical 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.


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:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age = 18 years

2. Signed informed consent

3. Suspected or confirmed community-acquired pneumonia

Exclusion Criteria:

1. Nosocomial pneumonia: development of symptoms after 48 hours of admission to the Emergency Department, or within 14 days after hospital discharge

2. Patients with lung cancer confirmed strongly suspected.

3. 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

4. Patients with asplenia in any order

5. Pregnant

6. Patients with known HIV infection

7. Stay indicated only for social reasons

8. Patients on antibiotics for any other reason

9. Patients with multiple trauma, burns or surgery grid size in the last 5 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
CRP
C-reactive protein guided antibiotic therapy plasma CRP measurement to guide the duration of antibiotic therapy
PCT
Procalcitonin guided antibiotic therapy plasma PCT measurement to guide the duration of antibiotic therapy

Locations

Country Name City State
Brazil Hospital das Clínicas - Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of antibiotic therapy for the first episode of infection 28 days No
Primary Total antibiotic exposure days per 1,000 days 28 days No
Primary Days alive without antibiotics 28 days No
Secondary All cause 28-day mortality 28 days Yes
Secondary clinical cure rate 28 days Yes
Secondary Infection relapse (diagnosed less than 48h after antibiotic discontinuation) 28 days Yes
Secondary Length of hospitalization stay Whole hospitalization No
Secondary In-hospital mortality 28 days Yes
Secondary Nosocomial infection rate 28 days Yes
Secondary Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection) 28 days Yes
Secondary Isolation of resistant bacteria 28 days Yes
Secondary All cause 90-day mortality 90 days Yes
Secondary costs of hospitalization Whole hospitalization Yes
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