Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

Scorpion Sting Envenomation Clinical Trial

Official title:

Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599923
• Other study ID #: AL-02/05
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2012
• Last updated: May 14, 2012
• Start date: May 2005
• Est. completion date: August 2006

Study information

• Verified date: May 2012
• Source: Instituto Bioclon S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

There is no FDA approved therapy for the treatment of scorpion envenomation in the United States. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms early in the clinical course while avoiding the clinical deterioration that can occur en route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than the present standard of care in the United States, midazolam, and faster-acting thus eliminating the need to transport most rural patients and reducing hospitalization time.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Poisoning
• Scorpion Sting Envenomation
• Scorpion Stings

Intervention

Biological:
• Antivenin Centruroides (scorpion) equine immune F(ab')2
3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.

Locations

Country	Name	City	State
Mexico	Children's Hospital of Morelos	Cuernavaca	Morelos

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Bioclon S.A. de C.V.	Universidad Nacional Autonoma de Mexico, University of Arizona

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Berg RA, Tarantino MD. Envenomation by the scorpion Centruroides exilicauda (C sculpturatus): severe and unusual manifestations. Pediatrics. 1991 Jun;87(6):930-3. — View Citation

Boyer LV, Theodorou AA, Berg RA, Mallie J; Arizona Envenomation Investigators, Chávez-Méndez A, García-Ubbelohde W, Hardiman S, Alagón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of clinically important systemic signs of scorpion envenomation within four hours after Alacramyn administration.		Assessments conducted at 1, 2 and 4 hours post administration	No
Secondary	Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment.		One hour	No