Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02668237
Other study ID # 1508188
Secondary ID 16-3679163522016
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05722938 - Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) Phase 3
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Recruiting NCT06065618 - Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Not yet recruiting NCT03675178 - Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia Phase 4
Not yet recruiting NCT04166110 - Antibiotic Therapy In Respiratory Tract Infections N/A
Completed NCT02380352 - Short-course Antimicrobial Therapy for Paediatric Respiratory Infections Phase 4
Completed NCT01671280 - Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) N/A
Completed NCT02555852 - Proton Pump Inhibitors and Risk of Community-acquired Pneumonia N/A
Recruiting NCT00752947 - Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors Phase 4
Completed NCT00140023 - Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia Phase 3
Recruiting NCT04089787 - Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia Phase 4
Completed NCT05356494 - Postural Drainage and PEP Technique in Community Acquired Pneumonia N/A
Completed NCT05133752 - Oral Nemonoxacin in Treating Elderly Patients With CAP Phase 4
Not yet recruiting NCT06291012 - Stopping Pneumonia Antibiotherapy Regimen Early Phase 4
Recruiting NCT05002192 - A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Completed NCT03452826 - Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia N/A
Terminated NCT04071041 - Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. Phase 3
Completed NCT03474991 - KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP Phase 3
Withdrawn NCT01662258 - Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP N/A
Completed NCT01683487 - Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Phase 4