Status:
ENROLLING_BY_INVITATION
Mobile App-Based Infection Monitoring in Familial Mediterranean Fever
Lead Sponsor:
Istanbul University
Conditions:
Familial Mediterranean Fever (FMF )
Infection
Eligibility:
All Genders
8-18 years
Brief Summary
Familial Mediterranean Fever (FMF) is an autoinflammatory disease characterized by recurrent episodes of fever, abdominal pain, and serositis. FMF attacks often present with fever and systemic symptom...
Detailed Description
Infections are well-recognized triggers of FMF attacks; however, the precise relationship between infection episodes and disease flares remains incompletely understood. Most available data on triggeri...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Children and adolescents aged 8-18 years
- FMF diagnosis established by Tel Hashomer and/or Eurofever criteria
- Regular follow-up at the participating pediatric rheumatology clinic
- Stable treatment regimen, defined as:
- Colchicine use for ≥ 4 weeks
- Biologic or other anti-inflammatory agents stable for ≥ 8 weeks (if applicable)
- Access to a smartphone or tablet (iOS/Android) with internet and ability to use the study mobile application (caregiver assistance allowed)
- Language proficiency (patient and/or caregiver) sufficient to use the app and respond to prompts
- Informed consent from a parent/guardian and assent from the child, as appropriate
- Exclusion Criteria
- Co-existing chronic inflammatory or autoimmune disorders that may confound flare/infection assessment (e.g., JIA, IBD, Behçet disease) other than FMF
- Known primary or secondary immunodeficiency or ongoing immunosuppressive chemotherapy outside standard FMF care
- Chronic active infection (e.g., TB, HBV, HCV, HIV) or acute febrile illness at enrollment precluding baseline assessment
- Cognitive, visual, or motor limitations preventing app use without caregiver support
- No reliable access to a compatible device or internet connection
- Concurrent participation in another clinical study likely to affect outcomes or reporting
- Anticipated non-adherence (e.g., inability to complete app entries) as judged by the investigator
- Refusal or withdrawal of consent/assent
Exclusion
Key Trial Info
Start Date :
November 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 15 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07212764
Start Date
November 5 2025
End Date
July 15 2026
Last Update
December 3 2025
Active Locations (1)
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1
Istanbul University Faculty of Medicine
Istanbul, Fatih, Turkey (Türkiye), 34093