Scorpion StingPhase 3NCT01415830
Compare Two Anti-Scorpion Venom Serum In Children
A Phase 3 study testing Anti-scorpion venom serum Birmex and Anti-scorpion venom serum Alacramyn in people with Scorpion Sting, run by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. at 1 site in Mexico.
Trial summary
The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Scorpion Sting
- What is being tested?
- Anti-scorpion venom serum Birmex and Anti-scorpion venom serum Alacramyn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2011to May 2012
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scorpion sting
- Either sex
- Age 1 to 15 years
- Signing an informed consent (signed by parent or guardian)
- Being residents of the state of Guanajuato
Who cannot join
- Previous treatment with gamma globulin or immunoglobulin
- Blood transfusion at any stage of life
- Patients treated with drugs that interact with anti-scorpion serum
- History or history of sensitivity or intolerance to anti-scorpion serum or horse products
- Pregnancy
- Any immunodeficiency
- Patients who have participated in a research protocol in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population
The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.
On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).
Read the detailed description
We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.
This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum (Alacramyn).
- Conditions
- Scorpion Sting
- Being tested
- Anti-scorpion venom serum Birmex, Anti-scorpion venom serum Alacramyn
- Keywords
- Anti-Scorpion venom serum, venom, efficacy, safety, children
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-scorpion venom serum BirmexBiological
Also called anti-scorpion venom serum
the dose may be required for the patient according to clinical manifestations and evolution
Anti-scorpion venom serum AlacramynBiological
Also called antiscorpion venom serum
The dose may be required fot the patient according to clinical manifestations and evolution
| Study group | Role | What they receive |
|---|---|---|
| Anti-scorpion venom serum Birmex | Experimental | Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex Receives: Biological: Anti-scorpion venom serum Alacramyn |
| Anti-scorpion venom serum Alacramyn | Active comparator | Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn) Receives: Biological: Anti-scorpion venom serum Birmex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of signs and symptoms of scorpion envenomation
Measured: after treatment (expected average of 12 hrs)
Secondary outcomes (1)
Evaluate the adverse events in every treated child
Measured: inmediately after treatment and until 5 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scorpion StingStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ma. Eugenia Jimenez-Corona, PhD, Principal investigator, Laboratorios de Biologicos y Reactivos de México SA de CV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415830
- Sponsor's protocol ID
- BIRMEX-ECA-03-2011
- Status last verified
- Feb 2013
- First submitted
- 8 Aug 2011
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population
- ClinicalTrials.gov ID
- NCT01415830
- Acronym / sponsor ID
- BIRMEX-ECA-03-2011
- Conditions
- Scorpion Sting
- Keywords
- Anti-Scorpion venom serum, venom, efficacy, safety, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.University, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Aug 2011 (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.
The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.
On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).
Detailed description
We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.
This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum (Alacramyn).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-scorpion venom serum Birmex | Experimental | Biological: Anti-scorpion venom serum AlacramynPatients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex |
| Anti-scorpion venom serum Alacramyn | Active comparator | Biological: Anti-scorpion venom serum BirmexPatients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn) |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Scorpion sting
- Either sex
- Age 1 to 15 years
- Signing an informed consent (signed by parent or guardian)
- Being residents of the state of Guanajuato
Key exclusion criteria (7 listed)
- Previous treatment with gamma globulin or immunoglobulin
- Blood transfusion at any stage of life
- Patients treated with drugs that interact with anti-scorpion serum
- History or history of sensitivity or intolerance to anti-scorpion serum or horse products
- Pregnancy
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 |
|---|---|---|
| Anti-scorpion venom serum BirmexAlso: anti-scorpion venom serumthe dose may be required for the patient according to clinical manifestations and evolution | Biological | Anti-scorpion venom serum Alacramyn |
| Anti-scorpion venom serum AlacramynAlso: antiscorpion venom serumThe dose may be required fot the patient according to clinical manifestations and evolution | Biological | Anti-scorpion venom serum Birmex |
Primary outcome
Resolution of signs and symptoms of scorpion envenomation
Time frame: after treatment (expected average of 12 hrs)
1 secondary outcome
Evaluate the adverse events in every treated child
Time frame: inmediately after treatment and until 5 days later
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 7 Feb 2013.
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.
Ma. Eugenia Jimenez-Corona, PhD principal investigator
Laboratorios de Biologicos y Reactivos de México SA de CV
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 Anti-scorpion venom serum Birmex and Anti-scorpion venom serum Alacramyn in people with Scorpion Sting, run by Laboratorios de Biologicos y Reactivos de México, 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 5 inclusion and 7 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 7 Feb 2013. 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 signs and symptoms of scorpion envenomation (time frame: after treatment (expected average of 12 hrs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2013.