NCT02668237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 9, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

January 22, 2016

Last Update Submit

July 21, 2025

Conditions

Community-Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: OptiPAC

Control Group

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

OptiPACOTHER

Molecular and urinary tests.

Experimental group
Usual careOTHER

Antibiotics for prevention.

Control Group

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Nosocomial pneumonia
  • Pleuropneumopathy
  • Pneumonia occurring in immunosuppressed and transplanted
  • Patient with proven allergy to antibiotics
  • Inability to perform certain microbiological samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Chu Marseille

Marseille, La Timone, 13385, France

Location

Chu Saint Etienne

Saint-Etienne, Saint Etienne, 42000, France

Location

Chu Brest

Brest, 29200, France

Location

CHU CAEN

Caen, France

Location

Chu Estaing

Clermont-Ferrand, 63003, France

Location

Chu Grenoble

Grenoble, 38043, France

Location

APHP - Béclère

Paris, France

Location

APHP - Necker

Paris, France

Location

Chu Reims

Reims, 51092, France

Location

Chu Strasbourg

Strasbourg, 67000, France

Location

Chu Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 39111697BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • CANTAIS Aymeric, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 29, 2016

Study Start

June 9, 2016

Primary Completion

December 28, 2018

Study Completion

January 14, 2019

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)