MoralityPhase 4NCT06287905
A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin
A Phase 4 study testing Prazosin Oral Tablet in people with Morality, run by Sohag University at 1 site in Egypt.
Trial summary
Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Morality
- What is being tested?
- Prazosin Oral Tablet
- Type of treatment
- Vaccines, Pill or oral medicine, 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 Feb 2023to 1 Jul 2024
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History and clinical diagnosis of scorpion sting
- Admit in Sohag University hospitals
- During the period from February 2023 to July 2024.
- Accepting informed written consent from the case itself or the first degree relative if the case will underage or in a coma.
Who cannot join
- .All other envenomation cases or poisoning will be excluded.
Trial locations and contacts
1 site in 1 country.
Mai M Abd El Kader, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Meray Medhat Shokry Zaghary
Sohag, 82515
Meray M Shokry Zaghary, +201028911003, drevanho2013@gmail.com
Mai M Abd El Kader, +201028911003, drevanho2013@gmail.com
About this study
Official title: A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin Drug for Scorpion Stings Management in Sohag University Hospitals
Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. The second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. Both groups will receive proper first aid and supportive treatment
Read the detailed description
Tools of the study:
- Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019). Dose of antivenom 1-1 ampoule intramuscular and/ or, 2-1 to 5 Polyvalent anti-scorpion serum ampoules produced by the vaccine \& serum institution (VACSERA)in Egypt according to the severity of the case on 200 to 500 ml glucose 5% infusion and assess the patient clinically to repeat the dose after 4 to 6 hours. (Shoreit et al., 2019)
- A prepared sheet containing
- the demographic characteristics of each patient
- Vital signs and degree of coma at time of admission of the patient.
- First aid management as resuscitation.
- Supportive management will be done to the patients during the admission will be recorded.
- Cardiac enzymes measurements, duration of hospital stay and the outcome of patients in each group.
- Conditions
- Morality
- Being tested
- Prazosin Oral Tablet
- Keywords
- mortality, scorpion, antivenom, prazosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prazosin Oral TabletDrug
1-Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019).
| Study group | Role | What they receive |
|---|---|---|
| group of antivenom only | No intervention | Dose of antivenom 1-1 ampoule intramuscular and/ or, 2-1 to 5 Polyvalent anti-scorpion serum ampoules produced by the vaccine \& serum institution (VACSERA)in Egypt according to the severity of the case on 200 to 500 ml glucose 5% infusion and assess the patient clinically to repeat the dose after 4 to 6 hours. (Shoreit et al., 2019) |
| group of adding prazosin plus standard treatment | Experimental | 1-Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019). Receives: Drug: Prazosin Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
record the mortality rate in the two groups during the hospital stay
Measured: "up to 1 month"
Secondary outcomes (1)
Morbidity
assess any complications with the patients in the two groups fever, allergy, hypotension
Measured: "through the study completion an average of a 1 year "
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Feb 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (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 MoralityStudies of the same condition, open and under way.
- More trials run by Sohag 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- observational comparative
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meray Medhat Shokry, Sohag University
- Investigators
- Meray M Shokry Zaghary, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287905
- Sponsor's protocol ID
- Soh-Med-23-02-24
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shokry Zaghary MM, Abd ElKader MM. A comparative study of using scorpion antivenom versus scorpion antivenom and prazosin drug for scorpion stings management in Sohag University Hospitals. BMC Pharmacol Toxicol. 2025 Feb 14;26(1):31. doi: 10.1186/s40360-025-00854-x.
PubMed 39953590
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin Drug for Scorpion Stings Management in Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06287905
- Acronym / sponsor ID
- Soh-Med-23-02-24
- Conditions
- Morality
- Keywords
- mortality, scorpion, antivenom, prazosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 1 Mar 2024 (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.
Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. The second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. Both groups will receive proper first aid and supportive treatment
Detailed description
Tools of the study:
- Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019). Dose of antivenom 1-1 ampoule intramuscular and/ or, 2-1 to 5 Polyvalent anti-scorpion serum ampoules produced by the vaccine \& serum institution (VACSERA)in Egypt according to the severity of the case on 200 to 500 ml glucose 5% infusion and assess the patient clinically to repeat the dose after 4 to 6 hours. (Shoreit et al., 2019)
- A prepared sheet containing
- the demographic characteristics of each patient
- Vital signs and degree of coma at time of admission of the patient.
- First aid management as resuscitation.
- Supportive management will be done to the patients during the admission will be recorded.
- Cardiac enzymes measurements, duration of hospital stay and the outcome of patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- observational comparative
| Arm | Type | Receives |
|---|---|---|
| group of antivenom only | No intervention | –Dose of antivenom 1-1 ampoule intramuscular and/ or, 2-1 to 5 Polyvalent anti-scorpion serum ampoules produced by the vaccine \& serum institution (VACSERA)in Egypt according to the severity of the case on 200 to 500 ml glucose 5% infusion and assess the patient clinically to repeat the dose after 4 to 6 hours. (Shoreit et al., 2019) |
| group of adding prazosin plus standard treatment | Experimental | Drug: Prazosin Oral Tablet1-Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019). |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- History and clinical diagnosis of scorpion sting
- Admit in Sohag University hospitals
- During the period from February 2023 to July 2024.
- Accepting informed written consent from the case itself or the first degree relative if the case will underage or in a coma.
Key exclusion criteria (1 listed)
- .All other envenomation cases or poisoning will be excluded.
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 |
|---|---|---|
| Prazosin Oral Tablet1-Dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. Prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. Every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. When pain is the only symptom, prophylaxis shouldn't be given. To avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (Shoreit et al., 2019). | Drug | group of adding prazosin plus standard treatment |
Primary outcome
Mortality
Time frame: "up to 1 month"
record the mortality rate in the two groups during the hospital stay
1 secondary outcome
Morbidity
Time frame: "through the study completion an average of a 1 year "
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 39953590Shokry Zaghary MM, Abd ElKader MM. A comparative study of using scorpion antivenom versus scorpion antivenom and prazosin drug for scorpion stings management in Sohag University Hospitals. BMC Pharmacol Toxicol. 2025 Feb 14;26(1):31. doi: 10.1186/s40360-025-00854-x.
- Individual participant dataSharing planned: No
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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.
Mai M Abd El Kader, PhD contact
Meray M Shokry Zaghary principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prazosin Oral Tablet in people with Morality, run by Sohag 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 4 inclusion and 1 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 1 Mar 2024. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meray M Shokry Zaghary, PhD (+201028911003, drevanho2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: "up to 1 month"). 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 NCT06287905, 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 1 Mar 2024.