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

Primary Purpose

Community-Acquired Pneumonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OptiPAC
Usual care
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Community-Acquired Pneumonia

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Marseille
  • Chu Brest
  • CHU CAEN
  • Chu Estaing
  • Chu Grenoble
  • APHP - Béclère
  • APHP - Necker
  • Chu Reims
  • Chu Saint Etienne
  • Chu Strasbourg
  • Chu Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

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.

The children will benefit from the usual care : an antibiotic prevention treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2016
Last Updated
January 24, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
BioMérieux
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1. Study Identification

Unique Protocol Identification Number
NCT02668237
Brief Title
Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Children CAP
Acronym
OptiPAC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 9, 2016 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
BioMérieux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Pneumonia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The children will benefit from the usual care : an antibiotic prevention treatment.
Intervention Type
Other
Intervention Name(s)
OptiPAC
Intervention Description
Molecular and urinary tests.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Antibiotics for prevention.
Primary Outcome Measure Information:
Title
Appropriate prescription of an anti-infection treatment.
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CANTAIS Aymeric, MD
Organizational Affiliation
CHU SAINT ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Marseille
City
Marseille
State/Province
La Timone
ZIP/Postal Code
13385
Country
France
Facility Name
Chu Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU CAEN
City
Caen
Country
France
Facility Name
Chu Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Chu Grenoble
City
Grenoble 9
ZIP/Postal Code
38043
Country
France
Facility Name
APHP - Béclère
City
Paris
Country
France
Facility Name
APHP - Necker
City
Paris
Country
France
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Chu Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42000
Country
France
Facility Name
Chu Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Chu Toulouse
City
Toulouse 9
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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