- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599923
Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this open label, confirmatory, controlled clinical trial in Mexico was to provide additional data safety and efficacy of Alacramyn® for treatment of patients envenomed by scorpion sting.
This study took place at Morelos Children's Hospital in Cuernavaca, Mexico.
Patients who arrived at the emergency department presenting with scorpion sting symptoms were evaluated for treatment with respect to the inclusion/exclusion criteria according to the study procedures. Only patients with clinically important systemic signs of scorpion sting envenomation were included in the study. Baseline measures included severity evaluation of the scorpion sting envenomation. The patient's vital signs, concomitant medication, medical history and demographic data were collected. Blood tests were done for haematology, chemistry, venom and anti-venom levels and urine test.
After informed consent and inclusion/exclusion criteria were obtained and verified, and the baseline measurements completed, three vials of Alacramyn® were administered. At the one hour assessment an additional vial of Alacramyn® was administered if important systemic signs of scorpion envenomation were present. The assessment was repeated at two hours and a final vial of Alacramyn® was administered if deemed necessary. Patient were discharged after the 4 hour assessment if symptoms were resolved. Prior to discharge repeat lab work, physical assessments, and vital signs were done. Those remaining for extended care underwent final study assessments at time of hospital discharge or at 24 hours after study drug infusion if hospitalization continued.
All patients who participated in the study were contacted 7 and 14 days after treatment, looking for symptoms suggestive of ongoing venom effect, delayed serum sickness, as well as for any other adverse event reported by the patient.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Morelos
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Cuernavaca, Morelos, Mexico
- Children's Hospital of Morelos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females 6 months to 18 years of age
- Presenting for emergency care within 5 hours with clinically important signs of scorpion sting envenomation
- Signed written Informed Consent by parent or legal guardian
- No participation in a clinical drug trial within the last month or concomitantly
Exclusion Criteria:
- Allergy to horse serum
- Use within the past 24 hours of drugs expected to alter immune response
- Use of any antivenom within the last month or concomitantly
- Underlying medical condition that significantly alters immune response
- Concurrent medical condition involving a baseline neurological status mimicking envenomation
- Pregnant and nursing women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alacramyn
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3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resolution of clinically important systemic signs of scorpion envenomation within four hours after Alacramyn administration.
Time Frame: Assessments conducted at 1, 2 and 4 hours post administration
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Assessments conducted at 1, 2 and 4 hours post administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment.
Time Frame: One hour
|
One hour
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Walter Garcia Ubbelohde, MD, Instituto Bioclon
- Principal Investigator: Leslie V. Boyer, MD, VIPER Institute, University of Arizona
- Principal Investigator: Neydi Osnaya, MD, Children's Hospital of Morelos
Publications and helpful links
General Publications
- Boyer LV, Theodorou AA, Berg RA, Mallie J; Arizona Envenomation Investigators, Chavez-Mendez A, Garcia-Ubbelohde W, Hardiman S, Alagon A. Antivenom for critically ill children with neurotoxicity from scorpion stings. N Engl J Med. 2009 May 14;360(20):2090-8. doi: 10.1056/NEJMoa0808455.
- Berg RA, Tarantino MD. Envenomation by the scorpion Centruroides exilicauda (C sculpturatus): severe and unusual manifestations. Pediatrics. 1991 Jun;87(6):930-3. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AL-02/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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