Drug HypersensitivityNPVDPTNCT02844712
Negative Predictive Value of Drug Provocation Tests to Beta-lactams
A study testing Evaluation of reexposure to a negatively tested betalactam in people with Drug Hypersensitivity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Drug Hypersensitivity
- What is being tested?
- Evaluation of reexposure to a negatively tested betalactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Nov 2016
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elderly patients with at least 5 years at the time of consultation for allergy suspected allergy to beta-lactam antibiotics in the University Hospital of Montpellier and with a negative provocation test to a betalactam
- The patient or the patient's legal representatives are not their opposition to participate in this study
- The patient must be affiliated or beneficiary in a health insurance system
Who cannot join
- The patient is exclusion period determined by a previous study
- The patient is under judicial protection, guardianship or curatorship
- The patient or the patient's legal representatives do not read fluently the French language
Trial locations and contacts
1 site in 1 country.
France1 site
Allergy Unit, Arnaud de Villeneuve Hospital, University Hospital of Montpellier
Montpellier, 34295
About this study
Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.
- Conditions
- Drug Hypersensitivity
- Being tested
- Evaluation of reexposure to a negatively tested betalactam
- Keywords
- Drug hypersensitivity, Betalactam, Drug provocation test
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of reexposure to a negatively tested betalactamOther
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of reexposure to a negatively tested betalactam | Other | Not described Receives: Other: Evaluation of reexposure to a negatively tested betalactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value of drug provocation tests to betalactams
Measured: one day
Secondary outcomes (1)
The types of reactions upon reexposure to a negatively tested betalactam
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionNov 2016 (estimated)
Why it stopped: End of the period of inclusion, NSN not achieved
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.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 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
- NCT02844712
- Sponsor's protocol ID
- 9394
- Acronym
- NPVDPT
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Predictive Value of Drug Provocation Tests to Beta-lactams
- ClinicalTrials.gov ID
- NCT02844712
- Acronym / sponsor ID
- NPVDPT / 9394
- Conditions
- Drug Hypersensitivity
- Keywords
- Drug hypersensitivity, Betalactam, Drug provocation test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of the period of inclusion, NSN not achieved
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (estimated)
- First posted
- 26 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.
Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of reexposure to a negatively tested betalactam | Other | Other: Evaluation of reexposure to a negatively tested betalactam |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Elderly patients with at least 5 years at the time of consultation for allergy suspected allergy to beta-lactam antibiotics in the University Hospital of Montpellier and with a negative provocation test to a betalactam
- The patient or the patient's legal representatives are not their opposition to participate in this study
- The patient must be affiliated or beneficiary in a health insurance system
Key exclusion criteria (3 listed)
- The patient is exclusion period determined by a previous study
- The patient is under judicial protection, guardianship or curatorship
- The patient or the patient's legal representatives do not read fluently the French language
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 |
|---|---|---|
| Evaluation of reexposure to a negatively tested betalactam | Other | Evaluation of reexposure to a negatively tested betalactam |
Primary outcome
Negative predictive value of drug provocation tests to betalactams
Time frame: one day
1 secondary outcome
The types of reactions upon reexposure to a negatively tested betalactam
Time frame: one day
Results and safety
The study was stopped early (reason given: End of the period of inclusion, NSN not achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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 Evaluation of reexposure to a negatively tested betalactam 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 3 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: stopped early, as of the sponsor's last update on 26 Jul 2016. 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 was stopped early (reason given: End of the period of inclusion, NSN not achieved). Results are not available in the source record.
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?
Negative predictive value of drug provocation tests to betalactams (time frame: one day). 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 26 Jul 2016.