Scorpion StingPhase 4NCT00739440
Randomized Controlled Trial to Compare Two Anti-scorpion Serums
A Phase 4 study testing serum antiscorpion in people with Scorpion Sting, run by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V..
Trial summary
The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Scorpion Sting
- What is being tested?
- serum antiscorpion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Nov 2008
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sting scorpion
- Informed consent
- Age 15-60
- Either sex
- Resident in study area
Who cannot join
- Previous treatment with gammaglobulin
- Blood transfusion at any stage of life
- Sensitivity or intolerance to serums antiscorpion or horse products
- Pregnancy
- Some immunodeficiency
About this study
Official title: Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum
The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum
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 15 and 60 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.
- Conditions
- Scorpion Sting
- Being tested
- serum antiscorpion
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum antiscorpionBiological
Also called anti-Scorpion venom Serum
The dose may be required for the patient according to clinical manifestations and evolution
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex Receives: Biological: serum antiscorpion |
| II | Experimental | Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn) Receives: Biological: serum antiscorpion |
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 posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionNov 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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
- Jimenez C Ma. Eugenia, PhD, Principal investigator, Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739440
- Sponsor's protocol ID
- Birmex-01-2008
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum
- ClinicalTrials.gov ID
- NCT00739440
- Acronym / sponsor ID
- Birmex-01-2008
- Conditions
- Scorpion Sting
- Phase
- Phase 4
- 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 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Aug 2008 (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 purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum
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 15 and 60 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Biological: serum antiscorpionPatients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex |
| II | Experimental | Biological: serum antiscorpionPatients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn) |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Sting scorpion
- Informed consent
- Age 15-60
- Either sex
- Resident in study area
Key exclusion criteria (5 listed)
- Previous treatment with gammaglobulin
- Blood transfusion at any stage of life
- Sensitivity or intolerance to serums antiscorpion or horse products
- Pregnancy
- Some immunodeficiency
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 |
|---|---|---|
| serum antiscorpionAlso: anti-Scorpion venom SerumThe dose may be required for the patient according to clinical manifestations and evolution | Biological | I, II |
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 Aug 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.
Jimenez C Ma. Eugenia, PhD principal investigator
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing serum antiscorpion in people with Scorpion Sting, run by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V..
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 5 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 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Aug 2013.