- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02847156
Impact of Respiratory Viral Infections in Infants With Cystic Fibrosis. (PREVIMUC)
Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.
The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.
Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Bron, Frankrig, 69677
- Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- infant <24 months with cystic fibrosis
Exclusion Criteria:
- patient >24 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: cystic fibrosis infants
1 year follow-up in CF infants
|
1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Respiratory Viral Infection
Tidsramme: up to 12 months
|
up to 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Identification of respiratory viruses in throat-swabs
Tidsramme: up to 12 months
|
A panel of 10 viruses will be tested using polymerase chain reaction (PCR) and RT-PCR technology.
|
up to 12 months
|
|
Number of antibiotics treatments (oral or IV)
Tidsramme: up to 12 months
|
up to 12 months
|
|
|
Number of bronchodilator administrations
Tidsramme: up to 12 months
|
up to 12 months
|
|
|
Number of corticosteroids administrations
Tidsramme: up to 12 months
|
up to 12 months
|
|
|
Number of hospitalization or hospital admission due to upper or lower RVI
Tidsramme: up to 12 months
|
up to 12 months
|
|
|
Identification of bacterial flora in throat-swabs
Tidsramme: up to 12 months
|
up to 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Stéphanie VRIELYNCK, MD, Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon, 69677 Bron Cedex, France
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 69HCL14_0276
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