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Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure (ALPHO)

Primary Purpose

Neuromuscular Blocking Agents Anaphylaxis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

intradermal pholcodine allergy test in cases

Blood sampling

About this trial

This is an interventional diagnostic trial for Neuromuscular Blocking Agents Anaphylaxis focused on measuring anaphylaxis, pholcodine, neuromuscular blocking agents

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, age ≥ 2 years old.
Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of occurrence of peranaesthetic anaphylactic reaction during anaesthesia with administration of NMBAs (only for case patient).
Having given his/her consent (or the 2 parents consent for minors).
Affiliated with a social security scheme or dependent.
Able to answer a medicinal product intake questionnaire
In a clinical condition compatible with skin tests (no skin disease or psychiatric illness, etc.) (only for case patient)
Having stopped any anti-histamine treatment at least 8 days previously (only for case patient).
With positive skin test for the suspected NMBA (ony for case patient).
Patient anaesthetised in a control recruitment centre (only for control patients)
Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic anaphylactic reaction whatever his medical history (only for control patients)

Exclusion Criteria:

Patients who have refused, or are unable to give their consent
Patients who have had negative control skin tests
Anaphylaxis suspected to be related to other drugs given on induction of anaesthesia, eg. antibiotics
Having presented with anaphylactic reaction during a previous anaesthesia without NMBA injection
Pregnant females at inclusion or during 12 months before anaesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

cases with NMBA anaphylaxis

controls

Arm Description

Patients who experienced NMBA anaphylaxis during anesthesia

Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis

Outcomes

Primary Outcome Measures

Exposure to pholcodine

Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's

Secondary Outcome Measures

Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.

Cases: 6 to 12 weeks after the general anesthetic procedure (corresponding to the day of inclusion) Controls: during their hospitalisation after the general anesthetic procedure (Maximum 90 days after the general anesthetic procedure, corresponding to the day of inclusion)

Concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.

Impact of non subjective sources in pholcodine exposure assessment

We will study if pholcodine exposure criteria measured by autoquestionnaire is modified by taking into account non subjectives sources which are the patient's pharmaceutical file and his drug history by his pharmacist's

Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.

IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L)

NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA.

Only for Cases : Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual)

Full Information

NCT ID

NCT02250729

First Posted

May 12, 2014

Last Updated

December 26, 2018

Sponsor

Central Hospital, Nancy, France

Collaborators

Zambon SpA, Laboratoires URGO, THE BOOTS COMPANY PLC, Pierre Fabre Medicament, LABORATOIRE HEPATOUM, Biocodex, Sanofi, Laboratoires Bouchara-Recordati, GlaxoSmithKline, ALLIANCE PHARMACEUTICALS LIMITED, BELL SONS & COMPANY, PINEWOOD LABORATORIES LIMITED, THORNTON & ROSS & Ross Ltd, ERNEST JACKSON & Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02250729

Brief Title

Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

Acronym

ALPHO

Official Title

Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (Actual)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls). The secondary objectives of the study are: To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups. To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file. To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition. To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine. To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuromuscular Blocking Agents Anaphylaxis

Keywords

anaphylaxis, pholcodine, neuromuscular blocking agents

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cases with NMBA anaphylaxis

Arm Type

Experimental

Arm Description

Patients who experienced NMBA anaphylaxis during anesthesia

Arm Title

controls

Arm Type

Other

Arm Description

Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis

Intervention Type

Other

Intervention Name(s)

intradermal pholcodine allergy test in cases

Intervention Type

Other

Intervention Name(s)

Blood sampling

Primary Outcome Measure Information:

Title

Exposure to pholcodine

Description

Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's

Time Frame

within the 12 months before the anesthetic procedure

Secondary Outcome Measure Information:

Title

Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.

Description

Time Frame

Between 1 day to 12 weeks after the general anesthetic procedure

Title

Time Frame

within the 12 months preceeding the general anesthesia

Title

Impact of non subjective sources in pholcodine exposure assessment

Description

Time Frame

within the 12 months preceeding general anesthetic procedure

Title

Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.

Description

IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L)

Time Frame

within the 12 months preceding the general anesthetic procedure

Title

NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA.

Description

Only for Cases : Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual)

Time Frame

6 to 12 weeks after the general anesthetic procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age ≥ 2 years old. Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of occurrence of peranaesthetic anaphylactic reaction during anaesthesia with administration of NMBAs (only for case patient). Having given his/her consent (or the 2 parents consent for minors). Affiliated with a social security scheme or dependent. Able to answer a medicinal product intake questionnaire In a clinical condition compatible with skin tests (no skin disease or psychiatric illness, etc.) (only for case patient) Having stopped any anti-histamine treatment at least 8 days previously (only for case patient). With positive skin test for the suspected NMBA (ony for case patient). Patient anaesthetised in a control recruitment centre (only for control patients) Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic anaphylactic reaction whatever his medical history (only for control patients) Exclusion Criteria: Patients who have refused, or are unable to give their consent Patients who have had negative control skin tests Anaphylaxis suspected to be related to other drugs given on induction of anaesthesia, eg. antibiotics Having presented with anaphylactic reaction during a previous anaesthesia without NMBA injection Pregnant females at inclusion or during 12 months before anaesthesia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre Gillet, MD PhD

pierre.gillet@univ.lorraine.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre GILLET, PU-PH MD

Organizational Affiliation

CHU de Nancy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul-Michel MERTES, PU-PH MD

Organizational Affiliation

CHU de Strasbourg

Official's Role

Study Director

Facility Information:

Facility Name

CHU d' ANGERS

City

Angers

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martine DROUET, Dr

Facility Name

CHU de Besançon

City

Besançon

ZIP/Postal Code

25030

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal GIRARDIN, MD

pgirardin@chu-besancon.fr

Facility Name

CHU de Bordeaux

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maryline Bordes

maryline.bordes@chu-bordeaux.fr

Facility Name

CHU de Caen

City

Caen

ZIP/Postal Code

14000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Delphine MARIOTTEFAUSSART, MD

mariotte-d@chu-caen.fr

Facility Name

CHU de Clermont-Ferrand

City

Clermont- Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omar OUTTAS, MD

oouttas@chu-clermontferrand.fr;

Facility Name

CHU de Dijon

City

Dijon

ZIP/Postal Code

21033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandrine SELTZER, MD

sandrine.seltzer@chu-dijon.fr

Facility Name

CHRU de Lille

City

Lille

ZIP/Postal Code

59037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

FACON Alain, MD

alain.facon@chru-lille.fr

Facility Name

CHU de Limoges

City

Limoges

ZIP/Postal Code

87042

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle ORSEL, MD

isabelle.orsel@chu-limoges.fr

Facility Name

AP-HM

City

Marseille

ZIP/Postal Code

13915

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marion GOUITAA-DETTORI, MD

marion.gouitaa@ap-hm.fr

Facility Name

CHU de MONTPELLIER

City

Montpellier

ZIP/Postal Code

34000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal DEMOLY, Pr

Facility Name

CHRU de Nancy

City

Nancy

ZIP/Postal Code

54000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gérard AUDIBERT, MD-PHD

g.audibert@chu-nancy.fr

Facility Name

CHU de NANTES

City

Nantes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ANAIS PIPET, Dr

Facility Name

CHU de Nice

City

Nice

ZIP/Postal Code

06000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sylvie LEROY, MD

leroy.s2@chu-nice.fr

Facility Name

Fondation Hôpital St Joseph

City

Paris

ZIP/Postal Code

75007

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Laure MEGRET-GABEAUD, Dr

Facility Name

AP-HP- Hôpital Bichat

City

Paris

ZIP/Postal Code

75877

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dan LONGROIS, MD- PHD

dan.longrois@bch.aphp.fr

Facility Name

AP-HP Paris TENON

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ANGELE SORIA, Dr

Facility Name

Hospices Civils de Lyon

City

Pierre-Bénite

ZIP/Postal Code

69495

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincent PIRIOU, MD

vincent.piriou@chu-lyon.fr

Facility Name

CHU de Poitiers

City

Poitiers

ZIP/Postal Code

86000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marion VERDAGUER, MD

marion.verdaguer@chu-poitiers.fr

Facility Name

CHU de Reims

City

Reims

ZIP/Postal Code

51100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Marc MALINVOSKY, MD-PHD

jmmalinovsky@chu-reims.fr

Facility Name

CHU de Rouen

City

Rouen

ZIP/Postal Code

76000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yannick MEUNIER, MD

yannick.meunier@chu-rouen.fr

Facility Name

CHU de Saint Etienne

City

Saint- Etienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charles DZVIGA, MD

c.dzviga@magic.fr

Facility Name

CHU de Strasbourg

City

Strasbourg

ZIP/Postal Code

670000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fréderic DE BLAY, MD- PHD

frederic.deblay@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Paul-Michel Mertes, MD- PHD

paul-michel.mertes@chru-strasbourg.fr

Facility Name

CHU de Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alain DIDIER, MD-PHD

didier.a@chu-toulouse.fr

Facility Name

CHU de TOURS

City

Tours

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cyrille HOARAU, Dr

12. IPD Sharing Statement

Learn more about this trial

Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

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Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure (ALPHO)

Neuromuscular Blocking Agents Anaphylaxis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial