Scorpion Sting EnvenomationPhase 3NCT01599923
Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
A Phase 3 study testing Antivenin Centruroides (scorpion) equine immune F(ab')2 in people with Scorpion Sting Envenomation, run by Instituto Bioclon S.A. de C.V. at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Scorpion Sting Envenomation
- What is being tested?
- Antivenin Centruroides (scorpion) equine immune F(ab')2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMexico
- Study dates
- May 2005to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
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.
Read the 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.
- Conditions
- Scorpion Sting Envenomation
- Being tested
- Antivenin Centruroides (scorpion) equine immune F(ab')2
- Keywords
- scorpion, envenomation, Alacramyn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antivenin Centruroides (scorpion) equine immune F(ab')2Biological
Also called Alacramyn, Anascorp
3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Alacramyn | Experimental | Not described Receives: Biological: Antivenin Centruroides (scorpion) equine immune F(ab')2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of clinically important systemic signs of scorpion envenomation within four hours after Alacramyn administration.
Measured: Assessments conducted at 1, 2 and 4 hours post administration
Secondary outcomes (1)
Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2005
- Primary completionJun 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scorpion Sting EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bioclon S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona, Universidad Nacional Autonoma de Mexico
- Responsible party
- Sponsor
- Investigators
- Walter Garcia Ubbelohde, MD, Study director, Instituto BioclonLeslie V. Boyer, MD, Principal investigator, VIPER Institute, University of ArizonaNeydi Osnaya, MD, Principal investigator, Children's Hospital of MorelosAlejandro Alagon, PhD, Study chair, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599923
- Sponsor's protocol ID
- AL-02/05
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19439743Berg 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.
PubMed 2034501
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
- ClinicalTrials.gov ID
- NCT01599923
- Acronym / sponsor ID
- AL-02/05
- Conditions
- Scorpion Sting Envenomation
- Keywords
- scorpion, envenomation, Alacramyn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto Bioclon S.A. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona, Universidad Nacional Autonoma de Mexico
- Study start
- May 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alacramyn | Experimental | Biological: Antivenin Centruroides (scorpion) equine immune F(ab')2 |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antivenin Centruroides (scorpion) equine immune F(ab')2Also: Alacramyn, Anascorp3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes. | Biological | Alacramyn |
Primary outcome
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
1 secondary outcome
Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment.
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Background: PubMed 19439743Boyer 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.
- Background: PubMed 2034501Berg 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Garcia Ubbelohde, MD study director
Instituto Bioclon
Leslie V. Boyer, MD principal investigator
VIPER Institute, University of Arizona
Neydi Osnaya, MD principal investigator
Children's Hospital of Morelos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antivenin Centruroides (scorpion) equine immune F(ab')2 in people with Scorpion Sting Envenomation, run by Instituto Bioclon S.A. de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599923, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.