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

Community-Acquired Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668237
• Other study ID #: 1508188
• Secondary ID: 16-3679163522016
• Status: Completed
• Phase: N/A
• Start date: June 9, 2016
• Est. completion date: January 14, 2019

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 14, 2019
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Community-Acquired Pneumonia
• Infection
• Pneumonia

Intervention

Other:
• OptiPAC
Molecular and urinary tests.
• Usual care
Antibiotics for prevention.

Locations

Country	Name	City	State
France	Chu Brest	Brest
France	CHU CAEN	Caen
France	Chu Estaing	Clermont-Ferrand
France	Chu Grenoble	Grenoble 9
France	Chu Marseille	Marseille	La Timone
France	APHP - Béclère	Paris
France	APHP - Necker	Paris
France	Chu Reims	Reims
France	Chu Saint Etienne	Saint Etienne
France	Chu Strasbourg	Strasbourg
France	Chu Toulouse	Toulouse 9

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	BioMérieux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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