Drug Hypersensitivity Clinical Trial
— NewBLOfficial title:
Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
| NCT number | NCT02839551 |
| Other study ID # | 9611 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 4, 2016 |
| Est. completion date | November 16, 2021 |
| Verified date | December 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 1252 |
| Est. completion date | November 16, 2021 |
| Est. primary completion date | November 16, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - patients with positive Drug Provocation Test (DPT) to beta-lactams Exclusion Criteria: - contra-indications to DPT - refusal of participation - vulnerable patients according to French regulation |
| Country | Name | City | State |
|---|---|---|---|
| France | University hospital of Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | up to 1 hour |
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