Scorpion Sting EnvenomationNCT00696683
Establishment of Natural History of Scorpion Envenomation
An observational study of Scorpion Sting Envenomation, run by Instituto Bioclon S.A. de C.V. at 1 site in United States.
Trial summary
This retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom. 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?
- None, this is an observational study
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2005
- Phase
- Observational
- 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
Study population: Male and female patients 6 months to 18 years of age who presented for emergency treatment of scorpion sting and who had clinically important systemic signs of envenomation were included.
Who may be able to join
- Males and females 6 months to 18 years of age
- Presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation
Who cannot join
- Use of any antivenom within the last month or concomitantly
- Signs and symptoms confined to local sting site
- Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy)
- Incomplete or unavailable medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Arizona Health Science Center & Tucson Medical Center
Tucson, Arizona, 210202
About this study
Official title: Establishment of Natural History of Scorpion Envenomation in the Absence of Antivenom Treatment in Pediatric Patients
This retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom. The study consisted of a review of hospital records of patients who were admitted for intensive care management of scorpion envenomation, at the only two hospitals in North America known to admit children routinely for scorpion sting management without antivenom. The standard of care consisted of symptomatic and supportive care, including airway maintenance, fluid and electrolyte support and, if necessary, sedation.
Read the detailed description
The study objective was to document the clinical syndrome of scorpion envenomation in the absence of antivenom treatment in pediatric patients. This was done to establish historical control data on the time from sting to the time of resolution of signs of envenomation. These historical control data are intended to be used for comparison with Alacramyn treated patients in two prospective studies being conducted in Mexico and the U.S.for which a control population could not otherwise be established.
The total duration of clinically important systemic signs of envenomation was determined based upon overall investigator assessment of the last signs of any respiratory compromise, any pathological agitation or other indicator of continuing illness (e.g., continuing need for sedative administration).
To facilitate comparison of these historical data with prospective open label trials, periodic assessments of the overall presence or absence of clinically important signs was performed. Periodic assessments were also performed for each individual component indicator of respiratory compromise and of pathological agitation, when available.
A research nurse reviewed hospital discharge diagnoses for all pediatric charts coded for "scorpion sting". For these cases demographic, diagnostic, and therapeutic data were entered on the case report form (CRF) as well as data necessary to assess compliance with study inclusion and exclusion criteria.
A physician subinvestigator reviewed the research nurse's findings for the key outcome indicators, which consisted of clinically important systemic signs of scorpion envenomation and adjunctive sedation treatment (dose and timing of dose) when medical judgment was required.
- Conditions
- Scorpion Sting Envenomation
- Being tested
- None, this is an observational study
- Keywords
- scorpion, sting, envenomation, antivenom
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, this is an observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| A | Patients from the identified scorpion envenomation cases, who met inclusion/exclusion criteria. Receives: Other: None, this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of overall duration of clinically important signs of scorpion envenomation (Clinically important signs of envenomation were divided into those indicative of respiratory distress and those comprising pathological agitation)
Measured: 4 hours or discharge
Secondary outcomes (1)
To characterize treatment in the absence of antivenom (total dose, maximum rate per hour and duration of use of midazolam)
Measured: 4 hours or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startAug 2004
- Primary completionAug 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bioclon S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Investigators
- Walter García, MD, Study chair, Instituto Bioclon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696683
- Sponsor's protocol ID
- AL-03/06
- Status last verified
- Jun 2008
- First submitted
- 11 Jun 2008
- Last updated
- 13 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Natural History of Scorpion Envenomation in the Absence of Antivenom Treatment in Pediatric Patients
- ClinicalTrials.gov ID
- NCT00696683
- Acronym / sponsor ID
- AL-03/06
- Conditions
- Scorpion Sting Envenomation
- Keywords
- scorpion, sting, envenomation, antivenom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Instituto Bioclon S.A. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- University of Arizona
- Study start
- Aug 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 13 Jun 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.
This retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom. The study consisted of a review of hospital records of patients who were admitted for intensive care management of scorpion envenomation, at the only two hospitals in North America known to admit children routinely for scorpion sting management without antivenom. The standard of care consisted of symptomatic and supportive care, including airway maintenance, fluid and electrolyte support and, if necessary, sedation.
Detailed description
The study objective was to document the clinical syndrome of scorpion envenomation in the absence of antivenom treatment in pediatric patients. This was done to establish historical control data on the time from sting to the time of resolution of signs of envenomation. These historical control data are intended to be used for comparison with Alacramyn treated patients in two prospective studies being conducted in Mexico and the U.S.for which a control population could not otherwise be established.
The total duration of clinically important systemic signs of envenomation was determined based upon overall investigator assessment of the last signs of any respiratory compromise, any pathological agitation or other indicator of continuing illness (e.g., continuing need for sedative administration).
To facilitate comparison of these historical data with prospective open label trials, periodic assessments of the overall presence or absence of clinically important signs was performed. Periodic assessments were also performed for each individual component indicator of respiratory compromise and of pathological agitation, when available.
A research nurse reviewed hospital discharge diagnoses for all pediatric charts coded for "scorpion sting". For these cases demographic, diagnostic, and therapeutic data were entered on the case report form (CRF) as well as data necessary to assess compliance with study inclusion and exclusion criteria.
A physician subinvestigator reviewed the research nurse's findings for the key outcome indicators, which consisted of clinically important systemic signs of scorpion envenomation and adjunctive sedation treatment (dose and timing of dose) when medical judgment was required.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: None, this is an observational studyPatients from the identified scorpion envenomation cases, who met inclusion/exclusion criteria. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female patients 6 months to 18 years of age who presented for emergency treatment of scorpion sting and who had clinically important systemic signs of envenomation were included.
Key inclusion criteria (2 listed)
- Males and females 6 months to 18 years of age
- Presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation
Key exclusion criteria (4 listed)
- Use of any antivenom within the last month or concomitantly
- Signs and symptoms confined to local sting site
- Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy)
- Incomplete or unavailable medical record
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 |
|---|---|---|
| None, this is an observational study | Other | A |
Primary outcome
Assessment of overall duration of clinically important signs of scorpion envenomation (Clinically important signs of envenomation were divided into those indicative of respiratory distress and those comprising pathological agitation)
Time frame: 4 hours or discharge
1 secondary outcome
To characterize treatment in the absence of antivenom (total dose, maximum rate per hour and duration of use of midazolam)
Time frame: 4 hours or discharge
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 13 Jun 2008.
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 García, MD study chair
Instituto Bioclon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scorpion Sting Envenomation, run by Instituto Bioclon S.A. de C.V. at 1 site in United States.
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 2 inclusion and 4 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 13 Jun 2008. 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 United States. 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.
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?
Assessment of overall duration of clinically important signs of scorpion envenomation (Clinically important signs of envenomation were divided into those indicative of respiratory distress and those comprising pathological agitation) (time frame: 4 hours or discharge). 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 13 Jun 2008.