FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02250729

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Central Hospital, Nancy, France

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Pierre GILLET, PU-PH MDPaul-Michel MERTES, PU-PH MD
Principal Investigator Affiliation CHU de NancyCHU de Strasbourg

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherIndustryIndustryOtherIndustryOtherIndustryIndustryIndustryIndustryOtherOtherOtherOtherOther
Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Neuromuscular Blocking Agents Anaphylaxis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU d' ANGERS, Angers, France

Status

Recruiting

Address

CHU d' ANGERS

Angers, ,

Site Contact

Martine DROUET, Dr

CHU de Besançon, Besançon, France

Status

Not yet recruiting

Address

CHU de Besançon

Besançon, , 25030

Site Contact

Pascal GIRARDIN, MD

pgirardin@chu-besancon.fr

CHU de Bordeaux, Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux

Bordeaux, , 33000

Site Contact

Maryline Bordes

maryline.bordes@chu-bordeaux.fr

CHU de Caen, Caen, France

Status

Recruiting

Address

CHU de Caen

Caen, , 14000

Site Contact

Delphine MARIOTTEFAUSSART, MD

mariotte-d@chu-caen.fr

CHU de Clermont-Ferrand, Clermont- Ferrand, France

Status

Recruiting

Address

CHU de Clermont-Ferrand

Clermont- Ferrand, , 63003

Site Contact

Omar OUTTAS, MD

oouttas@chu-clermontferrand.fr;

CHU de Dijon, Dijon, France

Status

Recruiting

Address

CHU de Dijon

Dijon, , 21033

Site Contact

Sandrine SELTZER, MD

sandrine.seltzer@chu-dijon.fr

CHRU de Lille, Lille, France

Status

Recruiting

Address

CHRU de Lille

Lille, , 59037

Site Contact

FACON Alain, MD

alain.facon@chru-lille.fr

CHU de Limoges, Limoges, France

Status

Recruiting

Address

CHU de Limoges

Limoges, , 87042

Site Contact

Isabelle ORSEL, MD

isabelle.orsel@chu-limoges.fr

AP-HM, Marseille, France

Status

Not yet recruiting

Address

AP-HM

Marseille, , 13915

Site Contact

Marion GOUITAA-DETTORI, MD

marion.gouitaa@ap-hm.fr

CHU de MONTPELLIER, Montpellier, France

Status

Recruiting

Address

CHU de MONTPELLIER

Montpellier, , 34000

Site Contact

Pascal DEMOLY, Pr

CHRU de Nancy, Nancy, France

Status

Recruiting

Address

CHRU de Nancy

Nancy, , 54000

Site Contact

Gérard AUDIBERT, MD-PHD

g.audibert@chu-nancy.fr

CHU de NANTES, Nantes, France

Status

Recruiting

Address

CHU de NANTES

Nantes, ,

Site Contact

ANAIS PIPET, Dr

CHU de Nice, Nice, France

Status

Recruiting

Address

CHU de Nice

Nice, , 06000

Site Contact

Sylvie LEROY, MD

leroy.s2@chu-nice.fr

Fondation Hôpital St Joseph, Paris, France

Status

Recruiting

Address

Fondation Hôpital St Joseph

Paris, , 75007

Site Contact

Marie-Laure MEGRET-GABEAUD, Dr

AP-HP- Hôpital Bichat, Paris, France

Status

Recruiting

Address

AP-HP- Hôpital Bichat

Paris, , 75877

Site Contact

Dan LONGROIS, MD- PHD

dan.longrois@bch.aphp.fr

AP-HP Paris TENON, Paris, France

Status

Recruiting

Address

AP-HP Paris TENON

Paris, ,

Site Contact

ANGELE SORIA, Dr

Hospices Civils de Lyon, Pierre-Bénite, France

Status

Recruiting

Address

Hospices Civils de Lyon

Pierre-Bénite, , 69495

Site Contact

Vincent PIRIOU, MD

vincent.piriou@chu-lyon.fr

CHU de Poitiers, Poitiers, France

Status

Recruiting

Address

CHU de Poitiers

Poitiers, , 86000

Site Contact

Marion VERDAGUER, MD

marion.verdaguer@chu-poitiers.fr

CHU de Reims, Reims, France

Status

Recruiting

Address

CHU de Reims

Reims, , 51100

Site Contact

Jean-Marc MALINVOSKY, MD-PHD

jmmalinovsky@chu-reims.fr

CHU de Rouen, Rouen, France

Status

Recruiting

Address

CHU de Rouen

Rouen, , 76000

Site Contact

Yannick MEUNIER, MD

yannick.meunier@chu-rouen.fr

CHU de Saint Etienne, Saint- Etienne, France

Status

Recruiting

Address

CHU de Saint Etienne

Saint- Etienne, , 42055

Site Contact

Charles DZVIGA, MD

c.dzviga@magic.fr

CHU de Strasbourg, Strasbourg, France

Status

Recruiting

Address

CHU de Strasbourg

Strasbourg, , 670000

Site Contact

Fréderic DE BLAY, MD- PHD

frederic.deblay@chru-strasbourg.fr

CHU de Toulouse, Toulouse, France

Status

Recruiting

Address

CHU de Toulouse

Toulouse, , 31059

Site Contact

Alain DIDIER, MD-PHD

didier.a@chu-toulouse.fr

CHU de TOURS, Tours, France

Status

Recruiting

Address

CHU de TOURS

Tours, ,

Site Contact

Cyrille HOARAU, Dr

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.