Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients
NCT ID: NCT00685230
Last Updated: 2011-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
15 participants
INTERVENTIONAL
2004-05-31
2005-10-31
Brief Summary
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The working hypotheses are as follows:
1. The investigational antivenom is safe as treatment of scorpion sting envenomation.
2. The investigational antivenom is effective as treatment of scorpion sting envenomation.
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Detailed Description
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This study will take place in two pediatric Intensive care units in Tucson, Arizona.
Patients who arrive at the emergency clinic presenting with scorpion sting symptoms will be 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 will be included in the study. Baseline measures will include severity evaluation of the scorpion sting envenomation. The patient's vital signs, concomitant medication, medical history and demographic data will be collected. Blood tests will be done for haematology, chemistry, venom and anti-venom levels and urine test.
After informed consent and inclusion7exclusion criteria have been obtained and verified, and the baseline measurements have been done, three vials of Alacramyn® or placebo will be administered. During the following 3 hours, midazolam will continue, if indicated for control of agitation.
Patients off midazolam sedation after receiving study drug and no longer manifesting clinically important systemic signs of scorpion envenomation will be discharge at 4 hours, or 2 hours following cessation of midazolam drip, whichever occurs later. Prior to discharge repeat lab work, physical assessments, and vital signs will be done. Patients still requiring midazolam sedation and/or manifesting clinically important systemic signs of scorpion envenomation will be treated with standard of care for the duration of clinical symptoms. Those remaining for extended care undergo final study assessments at time of hospital discharge or at 24 hours after study drug infusion if hospitalization continues.
All patients who participated in the study will be 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Alacramyn and midazolam as needed
Antivenin Centruroides (scorpion) equine immune F(ab)2
3 vials of Alacramyn reconstitued in 50 ml of normal saline as a IV infusion over 10 minutes.
2
placebo and midazolam as needed
Placebo
Placebo reconstituted in 50 ml of normal saline administered over 10 min
Interventions
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Antivenin Centruroides (scorpion) equine immune F(ab)2
3 vials of Alacramyn reconstitued in 50 ml of normal saline as a IV infusion over 10 minutes.
Placebo
Placebo reconstituted in 50 ml of normal saline administered over 10 min
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presenting for emergency treatment within 5 hours with clinically important systemic signs of scorpion sting envenomation.
* Signed written Informed Consent by patient or legal guardian.
* No participation in a clinical drug trial within the last month or concomitantly.
Exclusion Criteria
* Use within the past 24 hours of drugs expected to alter immune response: H1 or H2 blockers, corticosteroids.
* Use of any antivenom within the last month or concomitantly.
* Underlying medical conditions that significantly alter immune response: bone marrow suppression congenital or acquired immuno-deficiency state, chemotherapy and chronic corticosteroid use.
* Allergy to midazolam.
* More than 0.3mg/kg of body weight of midazolam administered during the hour prior to study drug infusion.
* Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy).
* Pregnant and nursing women.
6 Months
18 Years
ALL
No
Sponsors
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University of Arizona
OTHER
Universidad Nacional Autonoma de Mexico
OTHER
Instituto Bioclon S.A. de C.V.
INDUSTRY
Responsible Party
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Instituto Bioclon
Principal Investigators
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Leslie Boyer, MD
Role: PRINCIPAL_INVESTIGATOR
Poison and Drug Center
Walter Garcia, MD
Role: STUDY_DIRECTOR
Instituto Bioclon S.A. de C.V.
Alejandro Alagon, PhD
Role: STUDY_CHAIR
Universidad Nacional Autonoma de Mexico
Locations
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Tucson Medical Center
Tucson, Arizona, United States
University Medical Center
Tucson, Arizona, United States
Countries
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References
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Likes K, Banner W Jr, Chavez M. Centruroides exilicauda envenomation in Arizona. West J Med. 1984 Nov;141(5):634-7.
Connor, D.A., Seldon, B.S., Scorpion Envenomation. Chapter in Wilderness Medicine; Management of Wilderness and Environmental Emergencies. 3rd edition. Auerbach PS, ed., Mosby Yearbook, Inc. St. Louis, MO. pp 831-842
Gibly R, Williams M, Walter FG, McNally J, Conroy C, Berg RA. Continuous intravenous midazolam infusion for Centruroides exilicauda scorpion envenomation. Ann Emerg Med. 1999 Nov;34(5):620-5. doi: 10.1016/s0196-0644(99)70164-2.
Curry SC, Vance MV, Ryan PJ, Kunkel DB, Northey WT. Envenomation by the scorpion Centruroides sculpturatus. J Toxicol Clin Toxicol. 1983-1984;21(4-5):417-49. doi: 10.3109/15563658308990433.
Chavez-Haro A., Gonzalez J., Paniagua nJ., Efficiency and Security Comparison between Two Different Scorpion-derived Antivenom in Mexico, Abstract, Leon Study Data Analysis.
Gonzalez, C., et al, Development of an Immunoenzymatic Assay for the Quantification of Scorpion Venom in Plasma, Abstract, Cuernavaca, 2000
LoVecchio F, Welch S, Klemens J, Curry SC, Thomas R. Incidence of immediate and delayed hypersensitivity to Centruroides antivenom. Ann Emerg Med. 1999 Nov;34(5):615-9. doi: 10.1016/s0196-0644(99)70176-9.
Alagon Cano, A., Gozalez Juarez, C., From Serotherapy to Fabotherapy, Abstract, Cuernavaca, 1998.
Cabral-Soto, J., et al, Comparison of Efficacy between Two Antiscorpion Antivenoms, Abstract, Cuernavaca, 2000, Clinical Study Report, Randomized, Double-Blind, Variable dosing of Alacramyn in Patients With Scorpion Sting (this was done with two approved products in Mexico, Alacramyn and Birmex), March 2002.
Madrazo Navarro, M., et al, Animales Ponzoñosos en la Población Derechohabiente del IMSS 1990-1996.
Dart, R.C., Horowitz, R.S., Use of Antibodies as Antivenoms: A primitive Solution for Complex Problem? Rocky Mountain Poison and Drug Center, Denver Co, USA.
TESS Data Collection Manual (available upon request)
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.
Rachesky IJ, Banner W Jr, Dansky J, Tong T. Treatments for Centruroides exilicauda envenomation. Am J Dis Child. 1984 Dec;138(12):1136-9. doi: 10.1001/archpedi.1984.02140500042015.
Rimsza ME, Zimmerman DR, Bergeson PS. Scorpion envenomation. Pediatrics. 1980 Aug;66(2):298-302.
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.
Related Links
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The University of Arizona
Instituto de Biotecnologia de la UNAM
Other Identifiers
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AL-02/03
Identifier Type: -
Identifier Source: org_study_id
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