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SPAD in Adult Patients

NCT ID: NCT05664035

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2026-06-30

Brief Summary

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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, we 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.

Detailed Description

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Conditions

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Specific Antibody Deficiency Predominantly Antibody Deficiencies

Keywords

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Specific Antibody Deficiency Predominant antibody deficiencies Ig replacement therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Case group

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

Diagnosis of SPAD using immunization with PPV23

Intervention Type BIOLOGICAL

Diagnosis of SPAD using immunization with PPV23

Interventions

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Diagnosis of SPAD using immunization with PPV23

Diagnosis of SPAD using immunization with PPV23

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Healthcare network for rare immune and hematological disorders (MARIH)

UNKNOWN

Sponsor Role collaborator

Takeda

INDUSTRY

Sponsor Role collaborator

VitalAire

INDUSTRY

Sponsor Role collaborator

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume LEFEVRE, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

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Guillaume LEFEVRE, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Other Identifiers

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2022-A00574-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0699

Identifier Type: -

Identifier Source: org_study_id