Lille University Hospital
Lille, 59037, France
Location status: Recruiting
Location contact
GUILLAUME LEFEVRE, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05664035
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Lille, 59037, France
Location status: Recruiting
GUILLAUME LEFEVRE, MD, PhD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diagnosis of SPAD using immunization with PPV23
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
Time frame: Througth study completion, an average 24 months
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
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
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.
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.
Time frame: Througth study completion, an average 24 months
To collect serum and mononuclear cells for future research projects in SPAD and undiagnosed patients
Contact information is provided by the study sponsor or research team.
University Hospital, Lille
Other
Detection of Specific Polysaccharide Antibody Deficiency in Adult Patients With Unexplained Recurrent and/or Severe Bacterial Infections
Acronym: DETECT
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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