Impact of a molecular microbiology test for the diagnosis of pneumonia's cause in the use of antimicrobials

Conditions

Community-acquired pneumonia (CAP) MedDRA version: 20.0 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations

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Interventions

Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult patients (18 years of age or older), of both sexes, hospitalized with a diagnosis of CAP during first 24 hours since emergency department arrival. • Patient or his legal representative gives the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 146 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 294

Exclusion criteria

Exclusion criteria: • Pregnancy and / or nursing. • Severe immunocompromised patients (eg, chemotherapy or radiotherapy in the previous 90 days, use of immunosuppressive drugs, chronic use of corticosteroids at a minimum dose of 15 mg / day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplant, HIV patients with CD4 = 200 cells / mm3) • Imminent death (life expectancy = 24h) • Congestive heart failure (NYHA class 3 or 4). • Participation in another clinical trial of pharmacological treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the use of antimicrobials measured on days of antibiotic therapy (DOT) per 1000 stays in patients diagnosed with community acquired pneumonia.;Primary end point(s): To evaluate the absolute number of DOT-1000 stays in admitted patients diagnosed with CAP.;Timepoint(s) of evaluation of this end point: The main variable (DOT / 1000 stays) will be collected in the End of Study visit (30±5 days after discharge).; Secondary Objective: Effectiveness: ·patients achieve clinical stability. ·days until clinical stability. ·Quantify time of intravenous antibiotic treatment until passage to the oral route. ·Quantify total days of antibiotic treatment. ·Evaluate de-escalation of antibiotic treatment to another treatment of smaller spectrum. ·days of oxygen therapy. ·days in invasive and non-invasive ventilation. ·need for admission to the ICU. ·days of hospital admission. ·incidence of Clostridium difficile infection during the study. ·incidence of phlebitis derived from the use of intravenous antimicrobials. ·Estimate incidence of mortality. ·Evaluate incidence of readmission after hospital discharge. ·Evaluate costs derived from the use of microbiological tests used, the antibiotics used and the hospital admission. Safety: ·Number of adverse events related to the collection of the sample or with the integral molecular test. ·Number of adverse events related to the CAP up to 30±5 days after discharge.	—

Measure

Time frame

Main Objective: To evaluate the use of antimicrobials measured on days of antibiotic therapy (DOT) per 1000 stays in patients diagnosed with community acquired pneumonia.;Primary end point(s): To evaluate the absolute number of DOT-1000 stays in admitted patients diagnosed with CAP.;Timepoint(s) of evaluation of this end point: The main variable (DOT / 1000 stays) will be collected in the End of Study visit (30±5 days after discharge).; Secondary Objective: Effectiveness: ·patients achieve clinical stability. ·days until clinical stability. ·Quantify time of intravenous antibiotic treatment until passage to the oral route. ·Quantify total days of antibiotic treatment. ·Evaluate de-escalation of antibiotic treatment to another treatment of smaller spectrum. ·days of oxygen therapy. ·days in invasive and non-invasive ventilation. ·need for admission to the ICU. ·days of hospital admission. ·incidence of Clostridium difficile infection during the study. ·incidence of phlebitis derived from the use of intravenous antimicrobials. ·Estimate incidence of mortality. ·Evaluate incidence of readmission after hospital discharge. ·Evaluate costs derived from the use of microbiological tests used, the antibiotics used and the hospital admission. Safety: ·Number of adverse events related to the collection of the sample or with the integral molecular test. ·Number of adverse events related to the CAP up to 30±5 days after discharge.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary over the main variable (DOT): · Days of intravenous antibiotic treatment. · Days until de-escalation of antibiotic treatment to another of lower spectrum. · Days until antibiotic monotherapy. · Days until detection of the causal agent. Clinical secondary related to CAP : · Days of oxygen treatment · Days of invasive or non-invasive ventilation · Days of hospital admission. · Patients who are readmitted before 30±5 after hospital discharge. Secondary adverse events: · Patients with complications related to CAP until the end of the clinical trial. · Patients with medical complications not directly related to CAP until the end of the clinical trial. · Number of adverse events related to antibiotic therapy. · Number of adverse events related to antibiotic therapy. · Patients diagnosed with Clostridium difficile infection during the clinical trial. · Patients with phlebitis resulting from the use of intravenous antimicrobials. Mortality: · Patients deceased 5 days after the randomization (early mortality). · Patients deceased 30 days after randomization (mortality = 30 days). · Deceased patients, related to CAP during the clinical trial ( =30±5 days after hospital discharge). · Patients who died from any cause during the clinical trial (days admitted = 30±5 days after hospital discharge). ;Timepoint(s) of evaluation of this end point: During the treatment period of each patient in the study (up to 30 ± 5 days after discharge).	—

Measure

Time frame

Secondary end point(s): Secondary over the main variable (DOT): · Days of intravenous antibiotic treatment. · Days until de-escalation of antibiotic treatment to another of lower spectrum. · Days until antibiotic monotherapy. · Days until detection of the causal agent. Clinical secondary related to CAP : · Days of oxygen treatment · Days of invasive or non-invasive ventilation · Days of hospital admission. · Patients who are readmitted before 30±5 after hospital discharge. Secondary adverse events: · Patients with complications related to CAP until the end of the clinical trial. · Patients with medical complications not directly related to CAP until the end of the clinical trial. · Number of adverse events related to antibiotic therapy. · Number of adverse events related to antibiotic therapy. · Patients diagnosed with Clostridium difficile infection during the clinical trial. · Patients with phlebitis resulting from the use of intravenous antimicrobials. Mortality: · Patients deceased 5 days after the randomization (early mortality). · Patients deceased 30 days after randomization (mortality = 30 days). · Deceased patients, related to CAP during the clinical trial ( =30±5 days after hospital discharge). · Patients who died from any cause during the clinical trial (days admitted = 30±5 days after hospital discharge). ;Timepoint(s) of evaluation of this end point: During the treatment period of each patient in the study (up to 30 ± 5 days after discharge).

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Countries

Spain

Contacts

Public ContactDr. Gabriela Abelenda Alonso

Dr. Gabriela Abelenda Alonso (Servicio de Enfermedades Infecciosas) Hospital Universitario de Bellvitge

gabi.abelenda.alonso@gmail.com

Outcome results

None listed