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Hypersensitivity, ImmediateMEDIREPNCT05420935

Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room

A study testing IgG group, IgE group and IgG group + IgE group in people with Hypersensitivity, Immediate and Peri-operative Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
IgG group, IgE group and IgG group + IgE group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
12 Apr 2023to 15 Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Common to both groups:
  • Age ≥ 18 years old and ≤ 70 years old
  • Patient having presented an allergic reaction in the operating room in the last 10 years, regardless of the grade of severity, the causative agent or the type of anesthesia
  • Patient having benefited from an allergy-anaesthesia consultation in the investigator center
  • For IgE group:
  • presence of at least one positive skin test to one of the suspected agent (curare and/or antibiotic) during the allergist consultation
  • For the IgG group:
  • presence of circulating IgG-type antibodies directed against one of the suspected agents (curare, antibiotic, antiseptic), identified in the routine biological tests carried out at the time of the shock and / or the consultation of allergology.

Who cannot join

  • Common to both groups:
  • Absence of written informed consent
  • Protected person: under guardianship or curatorship
  • Patient without social security
  • Pregnancy of breast feeding
  • Ongoing immunosuppressive or chemotherapy
Show all 23Show fewer
  • Acute heart failure
  • Patient included in another interventional research with an exclusion period
  • For IgE group:
  • Taking oral or injectable anticoagulants
  • Taking a double antiplatelet aggregation
  • Previous sternotomy
  • Previous thoracic radiation therapy
  • Known allergy to local anesthesic or iodinated skin products
  • Previous major sternal cutaneous lesions
  • Prerequisites for carrying out the sternal sample in order to carry out a myelogram (IgE group):
  • Leukocytes \> 4 giga/L in the 2 months preceding inclusion
  • Platelets \> 100,000 / mm3 in the 2 months preceding inclusion
  • For the IgG group
  • Orthostatic hypotension
  • Realization of a blood donation in the 6 to 8 weeks preceding inclusion
  • Prerequisites for performing the blood sample (IgG group):
  • Hemoglobin \> 12.5 g/dL for women and \> 13 g/dL for men in the 2 months preceding inclusion

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aurelie Gouel, MD, PhD contact

00-33-1-40-25-83-55

aurelie.gouel@aphp.fr

Pierre Bruhns, PhD contact

00-33-1-45-68-86-29

bruhns@pasteur.fr

France1 site, 1 recruiting
  • Hôpital Bichat claude Bernard

    Paris, Paris, 75018

    Recruiting

Other trials in France

About this study

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.

Read the detailed description

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) used in the clinic (e.g., atracurium, suxamethonium, rocuronium, vecuronium) belong to the curare family and block the nicotinic acetylcholine receptor to cause muscle relaxation. They share the presence of quaternary ammonium groups that are required for binding the acetylcholine receptor, and thus for their biological activity. Even though NMBA are relatively safe molecules, two main types of adverse reactions have been reported.

The most striking are immediate and severe anti-drug reactions at NMBA infusion with 1/10,000 patients suffering from severe hypersensitivity reactions, i.e. anaphylaxis. Anaphylaxis is classically considered to rely on IgE antibodies against the culprit compound, and to involve massive histamine liberation by mast cells and basophils, following antigen-induced aggregation of IgE receptor (FcεRI)-bound specific IgE antibodies1. The clinical diagnosis of anaphylaxis to NMBA is based on this IgE paradigm. NMBA quaternary ammonium cations are considered their major allergenic epitopes2, even if patients are rarely hypersensitive to several NMBA, even closely related NMBA like rocuronium and vecuronium that derive from each other, suggesting that antibodies may bind NMBA-specific structures other than quaternary ammoniums. Antibodies may even interact with NMBA as a "whole" epitope due to NMBA very reduced size; NMBA indeed vary from 300-1,000 Da. Intriguingly, 10-20% of patients who experience NMBA-induced anaphylaxis do not present with any biological signs of IgE-dependent immune activation, suggestive of other potential mechanisms. 4 An IgG antibody pathway has recently been described in NMBA-induced human anaphylaxis, leading to Platelet-Activating Factor release, neutrophil and platelet activation, which may aggravate anaphylaxis in combination with the IgE-pathway or underlie anaphylaxis in the absence of specific IgE.

The other most common adverse reaction is not allergic in nature, and is due to prolonged presence of NMBA following surgery, i.e. "residual curarization". This very frequent complication (up to 83% of the patients) leads to adverse postoperative pulmonary events, pharyngeal dysfunction, urgent tracheal reintubation and prolonged stay in post-anesthesia care units that lead to a high economic burden13. The first option for pharmacological neuromuscular blockade reversal, prostigmine (used for atracurium reversal), is restricted to situations where half of the spontaneous reversal is effective. The second one is a synthetic cyclodextrin, sugammadex, that captures rocuronium or vecuronium in vivo within minutes following injection. Instant blockade reversal might be necessary, as in difficult intubation scenarios, explaining that it has been considered economically advantageous to administer sugammadex despite a cost of $100/dose, leading to a $400-$3,000 economy per patient.

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.

Being tested
IgG group, IgE group, IgG group + IgE group
Keywords
Hypersensitivity, IgE, IgG, repertoire, NMBA, anaphylaxis
Medical subject headings
Hypersensitivity, Immediate, Hypersensitivity, Epilepsy, Idiopathic Generalized, Anaphylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IgG groupDiagnostic test

    Will be performed :

    • a blood sampling of 5 ml (for realization of a basophil activation test)
    • a blood sampling of 250 ml
  • IgE groupDiagnostic test

    Will be performed :

    • a blood sampling of 5 ml (for realization of a basophil activation test)
    • a bone marrow sampling
  • IgG group + IgE groupDiagnostic test

    • a blood sampling of 5 ml (for realization of a basophil activation test)
    • a blood sampling of 250 ml
    • a bone marrow sampling
Study groups in NCT05420935
Study groupRoleWhat they receive
IgG groupOtherPatient in the IgG group will benefit from a blood sampling of 5 ml (for realization of a basophil activation test) and a blood sampling of 250 ml
Receives: Diagnostic Test: IgG group
IgE groupOtherPatient in the IgE will benefit from a blood sampling of 5 ml (for realization of a basophil activation test) and a bone marrow sampling (approx 2 ml)
Receives: Diagnostic Test: IgE group
IgG group + IgE groupOtherPatient in the IgG + IgE will benefit from a blood sampling of 5 ml (for realization of a basophil activation test), a blood sampling of 250 ml and a bone marrow sampling (approx 2 ml)
Receives: Diagnostic Test: IgG group + IgE group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 10 years

Secondary outcomes (8)
  1. Production of recombinant antibodies based on obtained sequences

    Purification system (AKTA 25L, Cytiva)

    Measured: up to 10 years

  2. Evaluate antibodies properties, such as specificity

    ELISA

    Measured: up to 10 years

  3. Evaluate antibodies properties, such as avidity

    Interferometry (Octet, ForteBio)

    Measured: up to 10 years

  4. 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

    Measured: up to 10 years

  5. 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

    Measured: up to 10 years

  6. 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

    Measured: up to 10 years

  7. 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

    Measured: up to 10 years

  8. 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

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2022
  2. Study start12 Apr 2023
  3. Primary completion12 Apr 2033 (estimated)
  4. Study completion15 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05420935
Sponsor's protocol ID
APHP211277
Acronym
MEDIREP
Status last verified
Sep 2024
First submitted
20 May 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IgG group, IgE group and IgG group + IgE group in people with Hypersensitivity, Immediate and Peri-operative Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurelie Gouel, MD, PhD (00-33-1-40-25-83-55, aurelie.gouel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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