HypersensitivityTRO-b-lactNCT03553251
Protocol of Reintroduction of Beta-lactams in Children at Low Risk of Anaphylaxis.
An observational study of Hypersensitivity and Beta Lactam Adverse Reaction, run by Nantes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin… Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity, Beta Lactam Adverse Reaction
- How many people
- 195 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2018to 19 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children under 16 years of age with a clinical history that is not suggestive of IgE-mediated anaphylaxis or toxiderma to beta-lactams.
Who may be able to join
- Children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test.
Who cannot join
- Refusal of the legal representatives of the subject for their child to participate in the study,
- If his age permits, refusal of the subject to participate in the study,
- Subject aged over 16,
- Pregnancy,
- Absence of affiliation of the subject to a social security scheme,
- Skin tests with incriminated beta-lactam already made before the consultation,
Show all 9Show fewer
- Existence of contraindications to the realization of oral reintroduction drug test with the suspected antibiotic,
- Existence of criteria in the initial reaction suggestive of a non-low risk of IgE-mediated or delayed hypersensitivity to the incriminated beta-lactam, Taking antihistamine, corticosteroids or beta-blockers within 5 days prior to the oral reintroduction drug test,
- Travel abroad of the child scheduled within 7 days of the oral reintroduction drug test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Beta-lactam Drug Reintroduction Protocol, Without Previous Skin Tests, in Children Under 16 Years of Age With a Clinical History That is Not Suggestive of Immunoglobulin E (IgE)-Mediated Anaphylaxis or Toxidermia to Beta-lactams.
The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. The primary endpoint will be the risk of a severe IgE-mediated or delayed hypersensitivity reaction in children who received beta-lactam drug reintroduction protocol prior to skin testing.
- Conditions
- Hypersensitivity, Beta Lactam Adverse Reaction
- Keywords
- Hypersensitivity, Beta Lactam Adverse Reaction
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction
Demonstrate a low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction, without previous skin tests, in children selected by a questionnaire as being at low risk of IgE-mediated or delayed
Measured: At the end of the study, after 2 years.
Secondary outcomes (2)
Risk evaluation
Evaluate a risk of IgE-mediated or delayed non-severe hypersensitivity reactions.
Measured: At the end of the study, after 2 years.
explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity
If an IgE-mediated or delayed hypersensitivity reaction (s), severe or not, occurs during the oral beta-lactam drug reintroductions, analyze all the information collected in the inclusion questionnaire (s) of the patient (s) concerned, in order to find the element (s) most likely to explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity despite initial selection of patients at low risk of reaction.
Measured: At the end of the study, after 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start7 Sep 2018
- Primary completion5 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553251
- Sponsor's protocol ID
- RC18_0193
- Acronym
- TRO-b-lact
- Status last verified
- Jun 2026
- First submitted
- 25 May 2018
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Beta-lactam Drug Reintroduction Protocol, Without Previous Skin Tests, in Children Under 16 Years of Age With a Clinical History That is Not Suggestive of Immunoglobulin E (IgE)-Mediated Anaphylaxis or Toxidermia to Beta-lactams.
- ClinicalTrials.gov ID
- NCT03553251
- Acronym / sponsor ID
- TRO-b-lact / RC18_0193
- Conditions
- Hypersensitivity, Beta Lactam Adverse Reaction
- Keywords
- Hypersensitivity, Beta Lactam Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. The primary endpoint will be the risk of a severe IgE-mediated or delayed hypersensitivity reaction in children who received beta-lactam drug reintroduction protocol prior to skin testing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children under 16 years of age with a clinical history that is not suggestive of IgE-mediated anaphylaxis or toxiderma to beta-lactams.
Key inclusion criteria (1 listed)
- Children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test.
Key exclusion criteria (9 listed)
- Refusal of the legal representatives of the subject for their child to participate in the study,
- If his age permits, refusal of the subject to participate in the study,
- Subject aged over 16,
- Pregnancy,
- Absence of affiliation of the subject to a social security scheme,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction
Time frame: At the end of the study, after 2 years.
Demonstrate a low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction, without previous skin tests, in children selected by a questionnaire as being at low risk of IgE-mediated or delayed
2 secondary outcomes
Risk evaluation
Time frame: At the end of the study, after 2 years.
explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity
Time frame: At the end of the study, after 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Related trials for Hypersensitivity
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity and Beta Lactam Adverse Reaction, run by Nantes University Hospital 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction (time frame: At the end of the study, after 2 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 24 Jun 2026.