Scorpion EnvenomationScorpionNCT06838715
Role of Steroids and Extended Scorpion Anti-Venom Use in Cardiac Affection Among Scorpion Stung Pediatric Cases
A study testing Dexamethasone in people with Scorpion Envenomation, run by Assiut University at 1 site in Egypt.
Trial summary
Scorpion envenomation is considered a serious public health issue in the Middle East and Northern Sahara . According to the world health organization (WHO), around 1.2 to 1.5 million individuals are suspected to scorpion stings annually in Middle East; with 3000 to 5000 deaths rate . Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Scorpion Envenomation
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Interventional
- 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 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with scorpion stings and diagnosed as grade 1, 2 \& 3 (according to recent history of scorpion sting and clinical presentation at the time of admission) .
Who cannot join
- Patients with history of cardiac disease, OR previous cardiac operation and or previous abnormal cardiac investigations .
- Patients with history of chronic renal, hepatic, chest or CNS diseases .
- Patients with chronic inflammatory diseases such as auto-immune diseases, with chronic use of corticosteroids .
- Envenomated cases that are described as grade 4 scorpion envenomation.
- Cases of scorpion sting above age of 18 years.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University Pediatric Hospital
Asyut
Zeinab Al- Badry Mohammed, Lecturer, 01095653919, Zeinab_albadry@aun.edu.eg
Marwa Khalifa Mohamed, Lecturer, 01004514945, marwakhalifa@aun.edu.eg
About this study
Scorpion envenomation is considered a serious public health issue in the Middle East and Northern Sahara . According to the world health organization (WHO), around 1.2 to 1.5 million individuals are suspected to scorpion stings annually in Middle East; with 3000 to 5000 deaths rate .
Read the detailed description
In Egypt, the percent of scorpion cases was 1.6% of all patients presented to Ain Shams University Poison Control Center during 2019.Initially within 1-2 hours of sting hypotension and bradycardia are encountered followed by hypotension and tachycardia between 4 and 48 hours due to severe left ventricular dysfunction and hypotension alone with good volume pulse and warm extremities is observed later in the recovery stage.
Cardiopulmonary problems such pulmonary edema and/or cardiogenic shock are the key characteristics of severe cases.Myocardial ischemia, release of catechol amines, and the direct impact of scorpion venom on cardiac fibers are the main three explanations to these cardiac complications.
Inflammation is one of the key processes involved in the pathogenesis. Neurotoxins can cause the release of inflammatory mediators. Increased pulmonary vascular permeability following the release of inflammatory mediators, such as platelet activating factor, leukotrienes, and prostaglandins had been suggested to explain the development of cardiogenic pulmonary edema.
Troponin is the biomarker of choice for the detection of cardiac injury. Cardiac troponin I (cTnI) isoform is predominant in myocardial tissue .Increased serum levels of pro-inflammatory cytokines, interleukins and tumor necrosis factor alpha had also been observed in many experimental studies following scorpion envenomation in plasma and in rat lungs respectively and on humans.
Scorpion Anti-Venom has a significant role in life saving of stung patients, but there is still a conflict about the duration of its administration mainly after occurrence of myocardial toxicity in stung patients. Corticosteroids are known to decrease the level of inflammatory mediators produced during the process of inflammation including cytokines. Dexamethasone is steroid with powerful anti-inflammatory effect that works by calming down body's immune response to reduce pain, itching and swelling .
- Conditions
- Scorpion Envenomation
- Being tested
- Dexamethasone
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Scorpion Anti Venom
Assessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases.
| Study group | Role | What they receive |
|---|---|---|
| Group of non extended anti-venom: | Active comparator | About 20 Patients treated with classical non extended anti-venom regimen as 3-5 ampoules by injection and supportive measure only with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. Receives: Drug: Dexamethasone |
| Group of Dexamethazone | Active comparator | About 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. Receives: Drug: Dexamethasone |
| Group of extended antivenom regimen | Active comparator | About 20 Patients treated with extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. Receives: Drug: Dexamethasone |
| Group of Dexamethazone and extended antivenom regimen | Active comparator | About 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) and extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of steroids and anti-venom regimen
80 of patients will take Treatment of the scorpion sting by using steroids and extended anti-venom regimen and assessing them after the treatment to see if they in need of intubation or ICU admission or hospital stay.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 May 2025 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scorpion EnvenomationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousef Ahmed Yousef Hasan, Assiut University
- Investigators
- Marwa Khalifa Mohamed, lecturer, Study director, Assiut UniversityNagwa Mahmoud Ali, professor, Study chair, Assiut UniversityHala Mohamed Fathi, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838715
- Sponsor's protocol ID
- Scorpion in Pediatrics
- Acronym
- Scorpion
- Status last verified
- Sep 2024
- First submitted
- 16 Dec 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abroug F, Ouanes-Besbes L, Tilouche N, Elatrous S. Scorpion envenomation: state of the art. Intensive Care Med. 2020 Mar;46(3):401-410. doi: 10.1007/s00134-020-05924-8. Epub 2020 Mar 3.
PubMed 32125457
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Steroids and Extended Scorpion Anti-Venom Use in Cardiac Affection Among Scorpion Stung Pediatric Cases
- ClinicalTrials.gov ID
- NCT06838715
- Acronym / sponsor ID
- Scorpion / Scorpion in Pediatrics
- Conditions
- Scorpion Envenomation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- 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.
Scorpion envenomation is considered a serious public health issue in the Middle East and Northern Sahara . According to the world health organization (WHO), around 1.2 to 1.5 million individuals are suspected to scorpion stings annually in Middle East; with 3000 to 5000 deaths rate .
Detailed description
In Egypt, the percent of scorpion cases was 1.6% of all patients presented to Ain Shams University Poison Control Center during 2019.Initially within 1-2 hours of sting hypotension and bradycardia are encountered followed by hypotension and tachycardia between 4 and 48 hours due to severe left ventricular dysfunction and hypotension alone with good volume pulse and warm extremities is observed later in the recovery stage.
Cardiopulmonary problems such pulmonary edema and/or cardiogenic shock are the key characteristics of severe cases.Myocardial ischemia, release of catechol amines, and the direct impact of scorpion venom on cardiac fibers are the main three explanations to these cardiac complications.
Inflammation is one of the key processes involved in the pathogenesis. Neurotoxins can cause the release of inflammatory mediators. Increased pulmonary vascular permeability following the release of inflammatory mediators, such as platelet activating factor, leukotrienes, and prostaglandins had been suggested to explain the development of cardiogenic pulmonary edema.
Troponin is the biomarker of choice for the detection of cardiac injury. Cardiac troponin I (cTnI) isoform is predominant in myocardial tissue .Increased serum levels of pro-inflammatory cytokines, interleukins and tumor necrosis factor alpha had also been observed in many experimental studies following scorpion envenomation in plasma and in rat lungs respectively and on humans.
Scorpion Anti-Venom has a significant role in life saving of stung patients, but there is still a conflict about the duration of its administration mainly after occurrence of myocardial toxicity in stung patients. Corticosteroids are known to decrease the level of inflammatory mediators produced during the process of inflammation including cytokines. Dexamethasone is steroid with powerful anti-inflammatory effect that works by calming down body's immune response to reduce pain, itching and swelling .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group of non extended anti-venom: | Active comparator | Drug: DexamethasoneAbout 20 Patients treated with classical non extended anti-venom regimen as 3-5 ampoules by injection and supportive measure only with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. |
| Group of Dexamethazone | Active comparator | Drug: DexamethasoneAbout 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. |
| Group of extended antivenom regimen | Active comparator | Drug: DexamethasoneAbout 20 Patients treated with extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. |
| Group of Dexamethazone and extended antivenom regimen | Active comparator | Drug: DexamethasoneAbout 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) and extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with scorpion stings and diagnosed as grade 1, 2 \& 3 (according to recent history of scorpion sting and clinical presentation at the time of admission) .
Key exclusion criteria (5 listed)
- Patients with history of cardiac disease, OR previous cardiac operation and or previous abnormal cardiac investigations .
- Patients with history of chronic renal, hepatic, chest or CNS diseases .
- Patients with chronic inflammatory diseases such as auto-immune diseases, with chronic use of corticosteroids .
- Envenomated cases that are described as grade 4 scorpion envenomation.
- Cases of scorpion sting above age of 18 years.
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 |
|---|---|---|
| DexamethasoneAlso: Scorpion Anti VenomAssessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases. | Drug | Group of Dexamethazone, Group of Dexamethazone and extended antivenom regimen, Group of extended antivenom regimen, Group of non extended anti-venom: |
Primary outcome
Safety and Tolerability of steroids and anti-venom regimen
Time frame: 7 days
80 of patients will take Treatment of the scorpion sting by using steroids and extended anti-venom regimen and assessing them after the treatment to see if they in need of intubation or ICU admission or hospital stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Results publication: PubMed 32125457Abroug F, Ouanes-Besbes L, Tilouche N, Elatrous S. Scorpion envenomation: state of the art. Intensive Care Med. 2020 Mar;46(3):401-410. doi: 10.1007/s00134-020-05924-8. Epub 2020 Mar 3.
- Individual participant dataSharing planned: No
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.
Marwa Khalifa Mohamed, lecturer study director
Assiut University
Nagwa Mahmoud Ali, professor study chair
Assiut University
Hala Mohamed Fathi, professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Scorpion Envenomation, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2025. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yousef Ahmed Yousef, M.D (01020098463, youssif_hassan@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of steroids and anti-venom regimen (time frame: 7 days). 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 NCT06838715, which also lists 1 linked publication.
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 21 Feb 2025.