CompletedNot Applicable

Systematic Search for Primary Immunodeficiency in Adults With Infections

France120 participantsStarted 2015-03

Plain-language summary

Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guidelines advocate screening adults for PIDs if they present recurrent benign especially upper and lower respiratory tract infections, or if they have experienced at least two severe bacterial infections and/or have a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in adult patients who present such recurrent infections and/or after the first severe bacterial infection, especially when the patients do not present with known, etiologically relevant comorbidities.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-65 yrs old patients * ≥ 2 bacterial upper or lower respiratory tract infections/years, for at least 2 years, or * ≥ 1 severe bacterial upper or lower respiratory tract infection requiring hospitalization and IV antibiotics, or * ≥ 1 invasive infection (meningitis, bacteriemia, arthritis) due to Streptococcus pneumoniae, group A Streptococcus, Haemophilus influenzae, Neisseria meningitidis or Neisseria gonorrhoeae Exclusion Criteria: * concomitant, systemic comorbidity that predisposes to infection (solid or hematological cancer, 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). * the presence of a local predisposing factor: cigarette smoking (\> 5 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis for pulmonary infections; cerebrospinal leak or preceding upper respiratory tract (URT) infections for non-meningococcal meningitis; oral, dental or skin condition for GAS infections * use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressants or cytotoxic chemotherapeutics * PID diagnosed before the infectious episode in question. * current or recent pregnancy * hospital-acquired infection (including infections of prostheses)…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study has already been completed, would it be worth asking whether the results have been published, and whether the findings about how common primary immunodeficiency is in adults with recurrent infections like mine could affect how my own case is evaluated?
2Given that this trial specifically looked at adults with recurrent or severe bacterial infections involving encapsulated bacteria — like pneumococcal, meningitis, or Haemophilus influenza infections — do my infection history and the types of bacteria involved match the pattern that might suggest an underlying primary immunodeficiency worth testing for?
3This study focused on conditions like antibody deficiency and complement deficiency — should I be asking to have my immune system tested for these specific problems, and if so, what tests would that actually involve?
4Even though this trial is completed and not enrolling, are there similar ongoing studies or clinical pathways at this hospital or institution where adults with my infection history are being systematically screened for immunodeficiency?
5If testing did reveal something like a complement or antibody deficiency, how would that change my treatment plan compared to continuing to manage my infections — such as my sinus infections or pneumonias — without that diagnosis?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria

Timeframe: At 6 months

Trial details

NCT IDNCT02972281

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03

View on ClinicalTrials.gov More Complement Deficiency trials