Drug HypersensitivityNewBLNCT02839551
Optimal Doses for Drug Provocation Tests to Beta-lactams
A study testing simplified drug provocation test in people with Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Drug Hypersensitivity
- What is being tested?
- simplified drug provocation test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,252 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2016to 16 Nov 2021
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with positive Drug Provocation Test (DPT) to beta-lactams
Who cannot join
- contra-indications to DPT
- refusal of participation
- vulnerable patients according to French regulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.
investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).
- Conditions
- Drug Hypersensitivity
- Being tested
- simplified drug provocation test
- Keywords
- Betalactams, Drug hypersensitivity, Drug provocation test, Reactive dose
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simplified drug provocation testProcedure or surgery
Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
| Study group | Role | What they receive |
|---|---|---|
| Simplified drug provocation test | Experimental | Assessment of the Hypersensitivity to betalactams by simplified drug provocation test Receives: Procedure: simplified drug provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the new simplified drug provocation test
Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start4 May 2016
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839551
- Sponsor's protocol ID
- RECHMPL15_0269
- Acronym
- NewBL
- Status last verified
- Dec 2021
- First submitted
- 18 Jul 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
- ClinicalTrials.gov ID
- NCT02839551
- Acronym / sponsor ID
- NewBL / RECHMPL15_0269
- Conditions
- Drug Hypersensitivity
- Keywords
- Betalactams, Drug hypersensitivity, Drug provocation test, Reactive dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,252 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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.
Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.
investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simplified drug provocation test | Experimental | Procedure: simplified drug provocation testAssessment of the Hypersensitivity to betalactams by simplified drug provocation test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with positive Drug Provocation Test (DPT) to beta-lactams
Key exclusion criteria (3 listed)
- contra-indications to DPT
- refusal of participation
- vulnerable patients according to French regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simplified drug provocation testAssessment of the Hypersensitivity to betalactams by simplified drug provocation test | Procedure or surgery | Simplified drug provocation test |
Primary outcome
Assessment of the new simplified drug provocation test
Time frame: up to 1 hour
Assessment of the non inferiority of the new drug provocation test compared to the present drug provocation test
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 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing simplified drug provocation test in people with Drug Hypersensitivity, run by University Hospital, Montpellier 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 3 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 30 Sep 2025. 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?
Assessment of the new simplified drug provocation test (time frame: up to 1 hour). 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 30 Sep 2025.