Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Children CAP (OptiPAC)

Impact on Anti-infectious Treatments of the Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Community-acquired Pneumonia of Children at Pediatric Emergencies

Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple severity scores. The etiology is never really identified, and the initial treatment is always based on probabilistic antibiotics, in the case of an bacterial infection, and by the way, potentially severe.

Molecular tests ("multiplex") allow the simultaneous detection of a huge number of pathogenic agents, virus and bacteria, are now available.

This project is based on a new strategy of diagnostic, using a multiplex PCR with quick results, coupled to an antigenic urinary test to allow a complete, quick, etiologic diagnostic as soon as children are supported in emergency.

Children are randomized in two groups during inclusions : quick diagnostic strategy versus usual practice. Analyse will be centralized on anti-infectious treatment optimization, with the aim to better treat patients, minimize the costs, and decrease selection pressure of multi-resistant bacteria.

Study Overview

• Status: Completed
• Conditions: Community-Acquired Pneumonia
• Intervention / Treatment: Other: OptiPAC; Other: Usual care

Detailed Description

Community-Acquired Pneumonia (CAP) of children are a recurrent pathology with multiple severity scores. Almost two out of three cases identified at emergency are treated in ambulatory because patients present a reassuring clinical state. The etiology is never really identified, and the initial treatment is always based on probabilistic antibiotics re-evaluated at H48, in the case of an bacterial infection, and by the way, potentially severe. This old conception is opposed to the new discoveries, more particularly in pediatric units where strictly viral pneumonia are more important than predicted (at least 30 to 50%) that leads to an hyper prescription of antibiotics, useless.

Molecular tests ("multiplex") allow the simultaneous detection of a huge number of pathogenic agents, virus and bacteria, are now available.

Aware of the non specificity of the clinical data to guide the diagnostic, this project is based on a new strategy of diagnostic, using a multiplex PCR with quick results (less than 2 hours, for 20 pathogens, including 17 viruses) coupled to an antigenic urinary test to allow a complete, quick, etiologic diagnostic as soon as children are supported in emergency.

Children are randomized in two groups during inclusions : quick diagnostic strategy versus usual practice. Analyse will be centralized on anti-infectious treatment optimization (antibiotics and antiviruses), with the aim to better treat patients, minimize the costs, and decrease selection pressure of multi-resistant bacteria.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHU Brest
  • Caen, France
    • CHU caen
  • Clermont-Ferrand, France, 63003
    • CHU Estaing
  • Grenoble 9, France, 38043
    • CHU Grenoble
  • Paris, France
    • APHP - Necker
  • Paris, France
    • APHP - Béclère
  • Reims, France, 51092
    • CHU Reims
  • Saint Etienne, France, 42000
    • CHU Saint Etienne
  • Strasbourg, France, 67000
    • CHU Strasbourg
  • Toulouse 9, France, 31059
    • CHU Toulouse
  • La Timone
    • Marseille, La Timone, France, 13385
      • CHU Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• In emergency for a Community-Acquired Pneumonia (according to the international rules based on an hyperthermia > 38,5°C associated to a radiological opacity)
• Informed Consent
• Possibility to take samples

Exclusion Criteria:

• Nosocomial pneumonia
• Pleuropneumopathy
• Pneumonia occurring in immunosuppressed and transplanted
• Patient with proven allergy to antibiotics
• Inability to perform certain microbiological samples

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The intervention for this group will be the use of a OptiPAC. A molecular technique and urinary tests will be performed to test a panel of infectious agents : the results will allow the children to benefit from an adapted treatment.	Other: OptiPAC; Molecular and urinary tests.
Active Comparator: Control Group; The children will benefit from the usual care : an antibiotic prevention treatment.	Other: Usual care; Antibiotics for prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate prescription of an anti-infection treatment.	Measure the impact on the therapeutic support of the creation of a quick, diagnostic, etiologic test of Community-Acquired Pneumonia of children (less than 3 months), supported in pediatric emergency versus usual practice. The main criterion will be the appropriate prescription of an anti-infection treatment, taking into account the microbiological results obtained a posteriori and clinical evolution. The primary outcome will be measured directly in the patients source folders.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: BioMérieux
• Investigators: Principal Investigator: CANTAIS Aymeric, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2016
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infections; Communicable Diseases; Pneumonia
• Other Study ID Numbers: 1508188; 16-367 (Other Identifier: CCTIRS); 916352 (Other Identifier: CNIL); 2016-A00483-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No