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NCT Number: NCT05664035

Frequency of SPAD in Adult Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, 59037, France

Location status: Recruiting

Location contact

GUILLAUME LEFEVRE, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

This multicenter observational prospective study will be conducted in 15 university or general hospitals, mostly centers included in the national network of the reference center CEREDIH. Pulmonologists, clinical immunologists and ENT specialists will be solicited in each center to refer patients for inclusions.

All patients who fulfill eligibility criteria will be tested for anti-pneumococcal polysaccharides (PnPSs) response with the 23-valent pneumococcal (unconjugated) vaccine (PPV23) (V1, Day 0: blood sample anti-PnPS antibodies, and immunization; V2, Day 28-56): blood sample for anti-PnPS antibodies).

If a SPAD would be diagnosed, the investigator will be free to consider prophylactic antibiotics and/or IgRT according to the medical history of the patient (notably in case of persistent infections while using prophylactic antibiotics). The efficiency on infections prevention and the impact on health-related quality of life (HRQoL) will be assessed 12 months after initiation of IgRT or prophylactic antibiotics (Visit 3).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diagnosis of SPAD using immunization with PPV23

Biological

Diagnosis of SPAD using immunization with PPV23

Primary outcomes

  1. To assess the frequency of SPAD in adult patients with unexplained recurrent bacterial respiratory infections

    Time frame: 4 to 8 weeks after immunization

    Diagnosis of SPAD according to the AAAAI proposed consensus criteria for an impaired selective response to PS using immunization with PPV23 and assessment of anti-PnPS IgG response by the serotype-specific WHO-standardized ELISA 4 to 8 weeks after immunization

Secondary outcomes

  1. To describe infectious and non infectious associated diseases, including allergy and autoimmune diseases, in SPAD patients.

    Time frame: Througth study completion, an average 24 months

  2. To assess the benefit of IgRT on the frequency of courses of antibiotic therapy.

    Time frame: Througth study completion, an average 24 months

    Outcome measure: number of courses of antibiotics in the 12 months following IgRT start compared to the 12 months before IgRT

  3. To assess the benefit of IgRT on QoL and daily life.

    Time frame: Througth study completion, an average 24 months

    Outcome measure: number of missed work or school/university days in the 12 months following IgRT start compared to the 12 months before IgRT

  4. To assess the benefit of prophylactic antibiotics on the frequency of courses of antibiotic therapy.

    Time frame: Througth study completion, an average 24 months

    Outcome measure: frequency of courses of antibiotics in the 6 months following prophylaxis start compared to the 12 months before and/or number of patients switched to IgRT during the first 12 months.

  5. To assess the benefit of prophylactic antibiotics on QoL and daily life.

    Time frame: Througth study completion, an average 24 months

    Outcome measure: number of missed work or school/university days in the 12 months following prophylaxis start (or at the end of prophylactic antibiotics) compared to the 12 months before.

  6. To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients.

    Time frame: Througth study completion, an average 24 months

    To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume LEFEVRE, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • French Healthcare network for rare immune and hematological disorders (MARIH)
  • Laboratoire français de Fractionnement et de Biotechnologies
  • Takeda
  • VitalAire

Registry information

Official study title

Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections

Acronym: DETECT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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