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

NCT ID: NCT02668237

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-09
• Study Completion Date: 2019-01-14

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.

Conditions

Community-Acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OptiPAC

Intervention Type: OTHER

Molecular and urinary tests.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Antibiotics for prevention.

Interventions

OptiPAC

Molecular and urinary tests.

Intervention Type: OTHER

Usual care

Antibiotics for prevention.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMérieux

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CANTAIS Aymeric, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Marseille

Marseille, La Timone, France

Chu Saint Etienne

Saint-Etienne, Saint Etienne, France

Chu Brest

Brest, , France

CHU CAEN

Caen, , France

Chu Estaing

Clermont-Ferrand, , France

Chu Grenoble

Grenoble, , France

APHP - Béclère

Paris, , France

APHP - Necker

Paris, , France

Chu Reims

Reims, , France

Chu Strasbourg

Strasbourg, , France

Chu Toulouse

Toulouse, , France

Countries

France

References

Cantais A, Pillet S, Rigaill J, Angoulvant F, Gras-Le-Guen C, Cros P, Thuiller C, Molly C, Tripodi L, Desbree A, Annino N, Verhoeven P, Carricajo A, Bourlet T, Chapelle C, Claudet I, Garcin A, Izopet J, Mory O, Pozzetto B; OPTIPAC study group. Impact of respiratory pathogens detection by a rapid multiplex polymerase chain reaction assay on the management of community-acquired pneumonia for children at the paediatric emergency department. A randomized controlled trial, the Optimization of Pneumonia Acute Care (OPTIPAC) study. Clin Microbiol Infect. 2025 Jan;31(1):64-70. doi: 10.1016/j.cmi.2024.08.001. Epub 2024 Aug 5.

Reference Type: BACKGROUND

PMID: 39111697 (View on PubMed)

Other Identifiers

16-367

Identifier Type: OTHER

Identifier Source: secondary_id

916352

Identifier Type: OTHER

Identifier Source: secondary_id

2016-A00483-48

Identifier Type: OTHER

Identifier Source: secondary_id

1508188

Identifier Type: -

Identifier Source: org_study_id