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| ID | Type | Description | Link |
|---|---|---|---|
| 16-367 | Other Identifier | CCTIRS | |
| 916352 | Other Identifier | CNIL | |
| 2016-A00483-48 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Active Comparator | The children will benefit from the usual care : an antibiotic prevention treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OptiPAC | Other | Molecular and urinary tests. |
| |
| Usual care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CANTAIS Aymeric, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Marseille | Marseille | La Timone | 13385 | France | ||
| Chu Saint Etienne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39111697 | Result | 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. |
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| Other |
Antibiotics for prevention. |
|
| Saint-Etienne |
| Saint Etienne |
| 42000 |
| France |
| Chu Brest | Brest | 29200 | France |
| CHU CAEN | Caen | France |
| Chu Estaing | Clermont-Ferrand | 63003 | France |
| Chu Grenoble | Grenoble | 38043 | France |
| APHP - Béclère | Paris | France |
| APHP - Necker | Paris | France |
| Chu Reims | Reims | 51092 | France |
| Chu Strasbourg | Strasbourg | 67000 | France |
| Chu Toulouse | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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