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Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

Study acronym: SPYSI
StatusUnknown
PhaseNot specified
Started2023-09-04
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 29, 2024 (before its estimated September 4, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-13
Trial status changed: Recruiting → Unknown
2024-03-28
Study Status v4
Trial statusRecruiting→Unknown
Primary completion date2025-09-01→2025-09-04
Completion date2026-09-01→2026-09-04
Start dateestimated 2023-09-01→confirmed 2023-09-04
2023-07-11
Study Status v3
Primary completion date2023-09-01→2025-09-01
Completion date2023-12-30→2026-09-01
Start date2021-09-01→2023-09-01
2021-10-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2021-08-27
Study Status, Outcome Measures v1
Secondary endpoints1 entry, revised
ToRate of to evaluate the sensitivity of our systematic screening
2021-07-26
Original filing
Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown. The aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.
Trial Details
NCT Number NCT04990908
Lead Sponsor University Hospital, Montpellier
Conditions Severe Infection, Severe Immune Deficiency
Enrollment 100 participants
Start Date 2023-09-04
Primary Completion 2025-09-04 (estimated)
Study Completion 2026-09-04 (estimated)
Updated on ClinicalTrials.gov 2024-03-29