Clinical trial NCT02668237: Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Children CAP
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
Overall status: COMPLETED
Phase: NA
Conditions: Community-Acquired Pneumonia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2016-01-29
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Appropriate prescription of an anti-infection treatment.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Chu Marseille
state: La Timone
city: Brest
country: France
facility: Chu Brest
city: Caen
country: France
facility: CHU CAEN
city: Clermont-Ferrand
country: France
facility: Chu Estaing
city: Grenoble 9
country: France
facility: Chu Grenoble
city: Paris
country: France
facility: APHP - Béclère
city: Paris
country: France
facility: APHP - Necker
city: Reims
country: France
facility: Chu Reims
city: Saint Etienne
country: France
facility: Chu Saint Etienne
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Toulouse 9
country: France
facility: Chu Toulouse
Study officials:
affiliation: CHU SAINT-ETIENNE
name: CANTAIS Aymeric, MD
role: PRINCIPAL_INVESTIGATOR
References: