Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.

Systemic Sclerosis Clinical Trial

— SCLERO-PID  

Official title:

Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271333
• Other study ID #: 2015_49
• Secondary ID: 2016-A00722-49
• Status: Recruiting
• Start date: April 10, 2018
• Est. completion date: April 2025

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: David Launay, MD,PhD
• Phone: 3 20 44 42 95
• Email: david.launay[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• systemic sclerosis
• Diffuse Infiltrating Pneumonia

Exclusion Criteria:

• infection
• other lung diseases
• non French native

Related Conditions & MeSH terms

• Pneumonia
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

Other:
• lung function tests
Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille
France	AH-HP, Hôpital Saint Antoine	Paris 12

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite criteria: forced vital capacity and CO diffusing capacity	Degradation of forced vital capacity (FVC) =10% and / or DLCO =15% of initial values at prospective follow-up at 24 months.	At 24 months
Secondary	composite criteria: forced vital capacity and CO diffusing capacity	Degradation of forced vital capacity (FVC) =10% and / or DLCO =15% of initial values at prospective follow-up at 12 months.	At 12 months