Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV

Spinal Muscular Atrophy Clinical Trial

— AVNIR  

Official title:

Exploratory Study of Respiratory Bacterial Infections or Superinfections and Colonizations in Patients With Spinal Muscular Atrophy Under NIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712330
• Other study ID #: PI2022_843_0095
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Arnaud BECOURT, MD
• Phone: 03.22.08.83.71
• Email: becourt.arnaud[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SMA (Spinal Muscular Atrophy) is a rare neuromuscular disease characterized by motoneuron damage. Symptoms consist of respiratory involvement with numerous respiratory infections and eventually respiratory failure, for which NIV (Non Invasive Ventilation) is often used. Ventilation machines are in close contact with the respiratory tract of patients. They contain heated water to humidify the circuit. These humid and warm environments are conducive to the development of bacteria such as Pseudomonas aeruginosa. In this context, it is interesting to look for the presence or absence of bacteria, in comparison with the respiratory ecology of the patients. The aim is to highlight the microbiological role of NIV on the occurrence of respiratory bacterial infections or secondary infections in patients with SMA. To do this, samples are taken from the machines, and ECBCs are performed on patients during respiratory physiotherapy sessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosis of AMS (previous diagnosis or new diagnosis during the inclusion period)

• Age from 0 to 12 years old

• Nusinersen treatment

• Benefiting from a NIV

• Current monitoring at the University Hospital of Amiens

Exclusion Criteria:

• Invasive ventilation on tracheotomy

• No ventilation

• Other treatment than Nusinersen or no treatment

• Parental refusal to participate in the study

Related Conditions & MeSH terms

• Atrophy
• Bacterial Infections
• Communicable Diseases
• Infections
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Non Invasive Ventilation
• Spinal Muscular Atrophy

Intervention

Other:
• non invasive ventilation samples
machine samples for bacterial culture will be performed
• patient samples
Patient samples for sputum culture
• parent questionnaire
parent questionnaire

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of hospitalization days for respiratory exacerbations with germs identical to protocol samples		one year