Poisoning by Scorpion StingPhase 2/3NCT01336660
A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco
A Phase 2/3 study testing Equine F(ab')2 antivenom in people with Poisoning by Scorpion Sting, run by Instituto Bioclon S.A. de C.V. at 2 sites in Morocco.
Trial summary
This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the treatment of North Africa and Middle East scorpions envenomation by reducing the severity of envenomation. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Poisoning by Scorpion Sting
- What is being tested?
- Equine F(ab')2 antivenom
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesMorocco
- Study dates
- 21 Jul 2018to 15 Nov 2018
- Phase
- Phase 2/3
- 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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 6 months to 15 years
- Class II B or III scorpion envenomation
- Presenting within 5 hours of sting
- Informed consent read and signed by parent or legal guardian
Who cannot join
- Unable to provide informed consent
- Prior use of antivenom for this envenomation
- Allergy to horse serum
- Pregnant or breast-feeding
- Patients with underlying condition mimicking symptoms of scorpion envenomation (congenital heart disease, chronic oxygen therapy, etcetera)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase 2/3 Study for Scorpion North Africa Middle East Envenomation With a Immune F(ab')2 (Equine) Antivenom Alacramyn NAMO. A Randomized, Double-Blind, Placebo-controlled, Prospective and Multicenter Study
This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the treatment of North Africa and Middle East scorpions envenomation by reducing the severity of envenomation. The primary endpoint is make a comparison between antivenom and placebo groups, at 4 hours after study drug, of the number of cases showing improvement in class of envenomation.
Read the detailed description
In an effort to shorten hospital stay and to further decrease mortality, a new antivenom has been developed. This antivenom is a third generation F(ab')2 "fabotherapeutic" agent.It is administered intravenously which should lead to rapid neutralization of circulating venom. This study will demonstrate whether or not use of the new antivenom in children receiving standardized supportive care leads to resolution of the syndrome within 4 hours of treatment.The onset of clinical symptoms following a scorpion envenomation is usually within 5 to 30 minutes following the sting.
Established a classification of the patient status to differentiate a simple scorpion sting from a severe envenomation. A simple sting (class I) is characterized by signs that are local only: pain at the inoculation point, redness, edema, and numbness.
A class II envenomation is characterized by the presence of some systemic signs: hypothermia, hyperthermia, chills, nausea, abdominal pain and diarrhea. Being 15 years old or younger or the presence of priapism, vomiting, sweating, or a body temperature greater than 39°C are factors predictive of severity.
A severe envenomation (class III) is characterized by cardiovascular failure, often leading to death; respiratory failure related to the cardiac failure; and neurologic failure due to hypoxia.
- Conditions
- Poisoning by Scorpion Sting
- Being tested
- Equine F(ab')2 antivenom, Intensive care support plus placebo
- Keywords
- Effectiveness, New Antivenom, North Africa and Middle East Scorpio Envenomation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine F(ab')2 antivenomBiological
Also called Alacramyn NA, Scorpion North Africa and Middle East Immune F(ab')2(Equine)
A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute
Intensive care support plus placeboOther
Intensive care support as needed plus placebo
| Study group | Role | What they receive |
|---|---|---|
| Equine F(ab')2 antivenom | Experimental | Intensive care support and Equine F(ab')2 antivenom Receives: Biological: Equine F(ab')2 antivenom |
| Placebo | Placebo comparator | Intensive care support plus placebo Receives: Other: Intensive care support plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation
Comparison between antivenom and placebo groups of the number of cases showing improvement in class of envenomation.
Measured: 4 hours after study drug
Secondary outcomes (1)
Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation.
Decrease in plasma venom levels from baseline to one hour after study drug administration; Respiratory rate (breaths per minute); Heart rate (beats per minute); Dose of dobutamine (cumulative, per hour);Incidence of cardiac failure; Incidence of ventilatory failure; Incidence of neurological failure; Mortality
Measured: To 16 hours after treatment until discharge time and date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study start21 Jul 2018
- Primary completion1 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poisoning by 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bioclon S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Antipoison et de Pharmacovigilane du Maroc, Institut Pasteur du Maroc
- Responsible party
- Sponsor
- Investigators
- Walter Garcia, MD, Study director, Instituto BioclonRachida Soulaymani, Pr, Study chair, Centre Antipoison et de Pharamacovigilance du MarocSanae Achour, Principal investigator, FES University HospitalAsmae Khattabi, Study chair, Ecole Nationale de Santé Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336660
- Sponsor's protocol ID
- XM-10/02
- Status last verified
- Dec 2018
- First submitted
- 14 Apr 2011
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Study for Scorpion North Africa Middle East Envenomation With a Immune F(ab')2 (Equine) Antivenom Alacramyn NAMO. A Randomized, Double-Blind, Placebo-controlled, Prospective and Multicenter Study
- ClinicalTrials.gov ID
- NCT01336660
- Acronym / sponsor ID
- XM-10/02
- Conditions
- Poisoning by Scorpion Sting
- Keywords
- Effectiveness, New Antivenom, North Africa and Middle East Scorpio Envenomation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Instituto Bioclon S.A. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- Centre Antipoison et de Pharmacovigilane du Maroc, Institut Pasteur du Maroc
- Study start
- 21 Jul 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 18 Apr 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.
This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the treatment of North Africa and Middle East scorpions envenomation by reducing the severity of envenomation. The primary endpoint is make a comparison between antivenom and placebo groups, at 4 hours after study drug, of the number of cases showing improvement in class of envenomation.
Detailed description
In an effort to shorten hospital stay and to further decrease mortality, a new antivenom has been developed. This antivenom is a third generation F(ab')2 "fabotherapeutic" agent.It is administered intravenously which should lead to rapid neutralization of circulating venom. This study will demonstrate whether or not use of the new antivenom in children receiving standardized supportive care leads to resolution of the syndrome within 4 hours of treatment.The onset of clinical symptoms following a scorpion envenomation is usually within 5 to 30 minutes following the sting.
Established a classification of the patient status to differentiate a simple scorpion sting from a severe envenomation. A simple sting (class I) is characterized by signs that are local only: pain at the inoculation point, redness, edema, and numbness.
A class II envenomation is characterized by the presence of some systemic signs: hypothermia, hyperthermia, chills, nausea, abdominal pain and diarrhea. Being 15 years old or younger or the presence of priapism, vomiting, sweating, or a body temperature greater than 39°C are factors predictive of severity.
A severe envenomation (class III) is characterized by cardiovascular failure, often leading to death; respiratory failure related to the cardiac failure; and neurologic failure due to hypoxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equine F(ab')2 antivenom | Experimental | Biological: Equine F(ab')2 antivenomIntensive care support and Equine F(ab')2 antivenom |
| Placebo | Placebo comparator | Other: Intensive care support plus placeboIntensive care support plus placebo |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female 6 months to 15 years
- Class II B or III scorpion envenomation
- Presenting within 5 hours of sting
- Informed consent read and signed by parent or legal guardian
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Prior use of antivenom for this envenomation
- Allergy to horse serum
- Pregnant or breast-feeding
- Patients with underlying condition mimicking symptoms of scorpion envenomation (congenital heart disease, chronic oxygen therapy, etcetera)
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 |
|---|---|---|
| Equine F(ab')2 antivenomAlso: Alacramyn NA, Scorpion North Africa and Middle East Immune F(ab')2(Equine)A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute | Biological | Equine F(ab')2 antivenom |
| Intensive care support plus placeboIntensive care support as needed plus placebo | Other | Placebo |
Primary outcome
To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation
Time frame: 4 hours after study drug
Comparison between antivenom and placebo groups of the number of cases showing improvement in class of envenomation.
1 secondary outcome
Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation.
Time frame: To 16 hours after treatment until discharge time and date
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 Dec 2018.
- Individual participant dataSharing planned: Undecided. not yet decided
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 Garcia, MD study director
Instituto Bioclon
Rachida Soulaymani, Pr study chair
Centre Antipoison et de Pharamacovigilance du Maroc
Sanae Achour principal investigator
FES University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Equine F(ab')2 antivenom in people with Poisoning by Scorpion Sting, run by Instituto Bioclon S.A. de C.V. at 2 sites in Morocco.
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 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Morocco. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation (time frame: 4 hours after study drug). 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 Dec 2018.