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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05420935
Other study ID # APHP211277
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 12, 2023
Est. completion date December 15, 2033

Study information

Verified date October 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Aurelie Gouel, MD, PhD
Phone 00-33-1-40-25-83-55
Email aurelie.gouel@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute per-anesthetic hypersensitivity reaction (HSA-PA) is a rapidly occurring systemic reaction following injection of a drug during anesthesia (mortality between 3 and 9%). The substances responsible for these reactions in France are curare in 60% of cases, followed by antibiotics. The main mechanism mentioned is an immediate systemic hypersensitivity immune reaction mediated by IgE antibodies (anaphylaxis). NeuroMuscular Blocking Agents (NMBA; curare) relax skeletal muscles to facilitate surgeries and permit intubation, but lead to adverse reactions: (a) severe hypersensitivity reactions (anaphylaxis) thought to rely on pre-existing anti-NMBA antibodies; (b) complications due to postoperative residual curarization. Identification of patients at risk remains suboptimal due to the lack of adequate tools to detect anti-NMBA antibodies. A capturing agent exists for only one out of the four most used NMBAs, allowing reversal of profound curarization. Case reports suggested that it might also ameliorate an ongoing anaphylaxis due to that NMBA. Based on strong preliminary results, our study proposes to characterize anti-drugs antibody repertoires in patients with various NMBA or antibiotics-anaphylaxis, describe activation pathways leading to anaphylaxis, develop and validate diagnostic and therapeutic molecules to ameliorate patient screening, NMBA-anaphylaxis and reverse profound neuromuscular block.


Description:

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Study Design


Intervention

Diagnostic Test:
IgG group
Will be performed : a blood sampling of 5 ml (for realization of a basophil activation test) a blood sampling of 250 ml
IgE group
Will be performed : a blood sampling of 5 ml (for realization of a basophil activation test) a bone marrow sampling
IgG group + IgE group
a blood sampling of 5 ml (for realization of a basophil activation test) a blood sampling of 250 ml a bone marrow sampling

Locations

Country Name City State
France Hôpital Bichat claude Bernard Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Obtain sequences of gene producers (VH and VL pairs) coding for the variable part of anti-drug antibodies, thanks to the isolation of B lymphocytes of antibodies directed against the responsible molecule, from blood cells or bone marrow up to 10 years
Secondary Production of recombinant antibodies based on obtained sequences Purification system (AKTA 25L, Cytiva) up to 10 years
Secondary Evaluate antibodies properties, such as specificity ELISA up to 10 years
Secondary Evaluate antibodies properties, such as avidity Interferometry (Octet, ForteBio) up to 10 years
Secondary Ability of antibodies expressed as N297A mutated human IgG1 to reduce or block target curare-induced neuromuscular blockade without an immune response triggered by the antibody drug Measure of muscle strength of mice up to 10 years
Secondary Ability of antibodies expressed as N297A mutated human IgG1 to reduce or block target curare-induced neuromuscular blockade without an immune response triggered by the antibody drug Measure of motricity of mice up to 10 years
Secondary Ability of antibodies expressed as N297A mutated human IgG1 to reduce or block target curare-induced neuromuscular blockade without an immune response triggered by the antibody drug Measure the survival rate of mice up to 10 years
Secondary Ability of antibodies expressed as N297A mutated human IgG1 to reduce or block target curare-induced neuromuscular blockade without an immune response triggered by the antibody drug Evaluate the absence of occurrence of anaphylactic shock up to 10 years
Secondary Core temperature loss greater than 3°C within 60 minutes after target drug injection only in mice pre-injected with anti-drug IgE or IgG Rectal probe thermometer for mice up to 10 years
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