| NCT ID | NCT05664035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Specific Antibody Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 99 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 99 participants in total. It began in 2023-03-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The DETECT study aims to demonstrate the importance of detecting SPAD in adult patients with recurrent benign and/or severe unexplained bacterial upper/lower respiratory tract infections. Unlike children in whom the deficit may be transient, long-term strategies are warranted in SPAD adult patients to prevent severe infections and lung disability. Beyond the diagnosis of this still unrecognized PID in adult patients, the investigators want to assess the impact of prophylactic antibiotics or IgRT on infections prevention and on quality of life in adult patients with the most severe clinical phenotypes, recurrent infections with high frequency of antibiotics take and/or recurrent infections with complications like bronchiectasis and/or severe infections requiring hospitalizations.
Eligibility Criteria
Inclusion Criteria: * 18 to 65 year old patients * With a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years, and fulfilling the specific following criteria: * Recurrent benign infections currently requiring 6 courses of antibiotics /year or more, or Bilateral bronchiectasis/bronchiolitis (after exclusion of cystic fibrosis and ciliary dyskinesia) AND recurrent benign infections currently requiring 3 courses of antibiotics /year or more or A history of severe upper/lower respiratory tract bacterial infection, and/or invasive infection with Streptococcus pneumonia, Streptococcus pyogenes or Haemophilus influenzae, which required hospitalization in the last 2 years, AND recurrent benign infections currently requiring 3 courses of antibiotics /year. * Normal serum IgG, IgA, IgM and IgG subclasses levels, normal CH50 and serum complement C3 and C4 proteins levels, normal T cells count * Normal B cell count, normal serum protein electrophoresis and immunofixation. (\* excepted for Pseudomonas aeruginosa colonization) Exclusion Criteria: * Any general condition that predisposes to infections: solid or hematological malignancies, diabetes mellitus, severe alcohol or intravenous drug abuse, chronic liver or kidney failure, human immunodeficiency virus infection, anatomic or functional asplenia, drug-induced 1 neutropenia, or solid organ or hematopoietic stem cell transplantation; * Any local predisposing factor to infections: cigarette smoking (\> 10 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive pulmonary disease, oral, dental or skin conditions favorizing infections, streptococcal skin infections * Any other SID or PID diagnosed before inclusion * Pregnancy * PPV23 administration in the last 2 years (risk of hyporesponsiveness)
Contact & Investigator
Guillaume LEFEVRE, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT05664035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Specific Antibody Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05664035 currently recruiting?
Yes, NCT05664035 is actively recruiting participants. Contact the research team at guillaume.lefevre@chu-lille.fr for enrollment information.
Where is the NCT05664035 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT05664035 clinical trial?
NCT05664035 is sponsored by University Hospital, Lille. The principal investigator is Guillaume LEFEVRE, MD,PhD at University Hospital, Lille. The trial plans to enroll 99 participants.