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

Not Applicable

Completed

• Conditions: Community-Acquired Pneumonia
• Interventions: Other: OptiPAC; Other: Usual care

• Registration Number: NCT02668237
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-06-09
• Primary Completion: 2018-12-28
• Study Completion: 2019-01-14
• Status Verified: 2019-07
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	OptiPAC	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.
Control Group	Usual care	The children will benefit from the usual care : an antibiotic prevention treatment.

Primary Outcome Measures

Name	Time	Method
Appropriate prescription of an anti-infection treatment.	Day 1	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.

Trial Locations

Locations (11)

Chu Brest; 🇫🇷 Brest, France

Chu Marseille; 🇫🇷 Marseille, La Timone, France

Chu Estaing; 🇫🇷 Clermont-Ferrand, France

CHU CAEN; 🇫🇷 Caen, France

APHP - Necker; 🇫🇷 Paris, France

Chu Grenoble; 🇫🇷 Grenoble 9, France

APHP - Béclère; 🇫🇷 Paris, France

Chu Reims; 🇫🇷 Reims, France

Chu Saint Etienne; 🇫🇷 Saint Etienne, France

Chu Strasbourg; 🇫🇷 Strasbourg, France

Chu Toulouse; 🇫🇷 Toulouse 9, France