Immunotherapy for treating insect venom allergies.
Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Inmunotek S.L. · NCT06790368
This study is testing a new treatment for people aged 14 and older with insect venom allergies to see if it can safely reduce their allergic reactions in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Inmunotek S.L. (industry) |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Alcorcón, Madrid and 2 other locations) |
| Trial ID | NCT06790368 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of immunotherapy for patients with hymenoptera venom allergy under real-life conditions. It involves a multicentric approach across various hospitals in Spain, where data will be collected prospectively from participants aged 14 and older who are sensitized to insect venom. The study will include controlled and spontaneous sting evaluations to assess the treatment's impact on allergic reactions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 and older who are allergic to hymenoptera venom and have not received immunotherapy in the past five years.
Not a fit: Patients who are pregnant, breastfeeding, or have previously undergone immunotherapy for hymenoptera venom within the last five years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for individuals suffering from hymenoptera venom allergies.
How similar studies have performed: Other studies have shown success with immunotherapy for insect venom allergies, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice. * Participants of both sexes aged 14 years or more. * Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years. * Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign. Exclusion Criteria: * Pregnant or breastfeeding women. * Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study. * Participants who do not agree to participate and/or do not sign the informed consent form. * Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.
Where this trial is running
Alcorcón, Madrid and 2 other locations
- Hospital Universitario Fundación Alcorcón — Alcorcón, Madrid, Spain (RECRUITING)
- Hospital Reina Sofía — Córdoba, Spain (RECRUITING)
- Hospital Universitario de Guadalajara — Guadalajara, Spain (RECRUITING)
Study contacts
- Principal investigator: Arantza Vega Castro — University of Guadalajara
- Study coordinator: Miguel Casanovas
- Email: mcasanovas@inmunotek.com
- Phone: +34 91208942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allergy, Insect Venom, Allergy Insect Stinging, Insect Sting Allergy, Allergy, Immunotherapy, Apis mellifera, Vespula sp, controlled sting