Snake BitePhase 1/2NCT00811239
A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus
A Phase 1/2 study testing Bungarus multicinctus-candidus Antivenom and Supportive Care in people with Snake Bite, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Snake Bite
- What is being tested?
- Bungarus multicinctus-candidus Antivenom and Supportive Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteVietnam
- Study dates
- Mar 2004to Dec 2006
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Envenomed by B. multicinctus
- Showed clinical signs of systemic envenomation (neuromuscular signs)
- Provided written informed consent (during the year 2006)
Who cannot join
- Pregnancy
- Patients had a known history of intolerance to equine serum
Trial locations and contacts
1 site in 1 country.
About this study
In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom.
Read the detailed description
Venomous snakebites constitute a serious health problem in many Asian countries. In Vietnam, the burden of snakebite on the public health stimulated Calmette to conduct original studies at the Vaccine Institute in Saigon over a hundred years ago and to develop the first snake antivenom ever.
In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus, which is the only krait species giving rise to significant morbidity and mortality in the area. Its venom contains toxins which can cause severe neuromuscular blockade but which do not give rise to swelling or necrosis at the site of the bite.
Supportive care is an important part of the management of snakebites, but antivenom administration is the mainstay therapy in the majority of medically significant envenomings. Such specific therapy may dramatically reduce the consequences of the envenomation. In Vietnam, no specific antivenom against B. multicinctus has been available until recently when it has produced for clinical use.
- Conditions
- Snake Bite
- Being tested
- Bungarus multicinctus-candidus Antivenom, Supportive Care
- Keywords
- antivenom, snake bite, Bungarus multicinctus, Vietnam
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bungarus multicinctus-candidus AntivenomDrug
Five to ten ampoules of antivenom, depending on severity of muscle paralysis, were diluted with isotonic glucose solution to have total 50 ml and infused intravenously by electric pump during one hour. After a period of 6-8 hours, a second infusion was administered, under similar condition to the first, if no clinical improvement or adverse reaction had been noted. The patients also received supportive care such as intubation, ventilation...if necessary.
Supportive CareOther
Supportive Care only (endotracheal intubation, mechanical ventilation...)
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | As the antivenom was not yet clinically available until 2006, all patients included during the first two years (2004-2005) received supportive therapy only. Receives: Other: Supportive Care |
| antivenom group | Active comparator | The patients included during the third year (2006) were treated with antivenom therapy and supportive care. Receives: Drug: Bungarus multicinctus-candidus Antivenom |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of mechanical ventilation
Measured: the length of ICU stay
Secondary outcomes (4)
clinical course during ICU stay
Measured: the length of ICU stay
complications (Ventilator associated pneumonia...)
Measured: the length of ICU stay
adverse effects (anaphylaxis, serum sickness...)
Measured: the length of ICU stay
hyponatremia, renal and liver function
Measured: the length of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startMar 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Snake BiteStudies 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 1/2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)
- Investigators
- Jonas Höjer, MD, PhD, Study director, Karorinska Institute, Swedish Poisons Information Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811239
- Sponsor's protocol ID
- antivenom
- Other IDs
- second study on snakebite
- Status last verified
- Dec 2008
- First submitted
- 16 Dec 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan JC, Cockram CS, Buckley T, Young K, Kay R, Tomlinson B. Evenoming by Bungarus multicinctus (many-banded krait) in Hong Kong. J Trop Med Hyg. 1995 Dec;98(6):457-60.
PubMed 8544231Pe T, Myint T, Htut A, Htut T, Myint AA, Aung NN. Envenoming by Chinese krait (Bungarus multicinctus) and banded krait (B. fasciatus) in Myanmar. Trans R Soc Trop Med Hyg. 1997 Nov-Dec;91(6):686-8. doi: 10.1016/s0035-9203(97)90524-1.
PubMed 9509180Cheng AC, Winkel KD. Snakebite and antivenoms in the Asia-Pacific: wokabaut wantaim, raka hebou ("walking together"). Med J Aust. 2001 Dec 3-17;175(11-12):648-51. doi: 10.5694/j.1326-5377.2001.tb143762.x. No abstract available.
PubMed 11837876Dart RC, McNally J. Efficacy, safety, and use of snake antivenoms in the United States. Ann Emerg Med. 2001 Feb;37(2):181-8. doi: 10.1067/mem.2001.113372.
PubMed 11174237White J. Envenoming and antivenom use in Australia. Toxicon. 1998 Nov;36(11):1483-92. doi: 10.1016/s0041-0101(98)00138-x.
PubMed 9792162Karlson-Stiber C, Persson H, Heath A, Smith D, al-Abdulla IH, Sjostrom L. First clinical experiences with specific sheep Fab fragments in snake bite. Report of a multicentre study of Vipera berus envenoming. J Intern Med. 1997 Jan;241(1):53-8. doi: 10.1046/j.1365-2796.1997.80896000.x.
PubMed 9042094Ha TH, Hojer J, Trinh XK, Nguyen TD. A controlled clinical trial of a novel antivenom in patients envenomed by Bungarus multicinctus. J Med Toxicol. 2010 Dec;6(4):393-7. doi: 10.1007/s13181-010-0051-4.
PubMed 20358414
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus
- ClinicalTrials.gov ID
- NCT00811239
- Acronym / sponsor ID
- antivenom
- Conditions
- Snake Bite
- Keywords
- antivenom, snake bite, Bungarus multicinctus, Vietnam
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)
- Study start
- Mar 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Dec 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.
In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom.
Detailed description
Venomous snakebites constitute a serious health problem in many Asian countries. In Vietnam, the burden of snakebite on the public health stimulated Calmette to conduct original studies at the Vaccine Institute in Saigon over a hundred years ago and to develop the first snake antivenom ever.
In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus, which is the only krait species giving rise to significant morbidity and mortality in the area. Its venom contains toxins which can cause severe neuromuscular blockade but which do not give rise to swelling or necrosis at the site of the bite.
Supportive care is an important part of the management of snakebites, but antivenom administration is the mainstay therapy in the majority of medically significant envenomings. Such specific therapy may dramatically reduce the consequences of the envenomation. In Vietnam, no specific antivenom against B. multicinctus has been available until recently when it has produced for clinical use.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Supportive CareAs the antivenom was not yet clinically available until 2006, all patients included during the first two years (2004-2005) received supportive therapy only. |
| antivenom group | Active comparator | Drug: Bungarus multicinctus-candidus AntivenomThe patients included during the third year (2006) were treated with antivenom therapy and supportive care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Envenomed by B. multicinctus
- Showed clinical signs of systemic envenomation (neuromuscular signs)
- Provided written informed consent (during the year 2006)
Key exclusion criteria (2 listed)
- Pregnancy
- Patients had a known history of intolerance to equine serum
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 |
|---|---|---|
| Bungarus multicinctus-candidus AntivenomFive to ten ampoules of antivenom, depending on severity of muscle paralysis, were diluted with isotonic glucose solution to have total 50 ml and infused intravenously by electric pump during one hour. After a period of 6-8 hours, a second infusion was administered, under similar condition to the first, if no clinical improvement or adverse reaction had been noted. The patients also received supportive care such as intubation, ventilation...if necessary. | Drug | antivenom group |
| Supportive CareSupportive Care only (endotracheal intubation, mechanical ventilation...) | Other | control group |
Primary outcome
duration of mechanical ventilation
Time frame: the length of ICU stay
4 secondary outcomes
clinical course during ICU stay
Time frame: the length of ICU stay
complications (Ventilator associated pneumonia...)
Time frame: the length of ICU stay
adverse effects (anaphylaxis, serum sickness...)
Time frame: the length of ICU stay
hyponatremia, renal and liver function
Time frame: the length of ICU stay
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 18 Dec 2008.
- Results publication: PubMed 8544231Chan JC, Cockram CS, Buckley T, Young K, Kay R, Tomlinson B. Evenoming by Bungarus multicinctus (many-banded krait) in Hong Kong. J Trop Med Hyg. 1995 Dec;98(6):457-60.
- Results publication: PubMed 9509180Pe T, Myint T, Htut A, Htut T, Myint AA, Aung NN. Envenoming by Chinese krait (Bungarus multicinctus) and banded krait (B. fasciatus) in Myanmar. Trans R Soc Trop Med Hyg. 1997 Nov-Dec;91(6):686-8. doi: 10.1016/s0035-9203(97)90524-1.
- Results publication: PubMed 11837876Cheng AC, Winkel KD. Snakebite and antivenoms in the Asia-Pacific: wokabaut wantaim, raka hebou ("walking together"). Med J Aust. 2001 Dec 3-17;175(11-12):648-51. doi: 10.5694/j.1326-5377.2001.tb143762.x. No abstract available.
- Results publication: PubMed 11174237Dart RC, McNally J. Efficacy, safety, and use of snake antivenoms in the United States. Ann Emerg Med. 2001 Feb;37(2):181-8. doi: 10.1067/mem.2001.113372.
- Results publication: PubMed 9792162White J. Envenoming and antivenom use in Australia. Toxicon. 1998 Nov;36(11):1483-92. doi: 10.1016/s0041-0101(98)00138-x.
- Results publication: PubMed 9042094Karlson-Stiber C, Persson H, Heath A, Smith D, al-Abdulla IH, Sjostrom L. First clinical experiences with specific sheep Fab fragments in snake bite. Report of a multicentre study of Vipera berus envenoming. J Intern Med. 1997 Jan;241(1):53-8. doi: 10.1046/j.1365-2796.1997.80896000.x.
- Derived from this study: PubMed 20358414Ha TH, Hojer J, Trinh XK, Nguyen TD. A controlled clinical trial of a novel antivenom in patients envenomed by Bungarus multicinctus. J Med Toxicol. 2010 Dec;6(4):393-7. doi: 10.1007/s13181-010-0051-4.
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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.
Jonas Höjer, MD, PhD study director
Karorinska Institute, Swedish Poisons Information Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bungarus multicinctus-candidus Antivenom and Supportive Care in people with Snake Bite, run by Hanoi Medical University at 1 site in Vietnam.
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 3 inclusion and 2 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 18 Dec 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 Vietnam. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
duration of mechanical ventilation (time frame: the length of ICU stay). 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 NCT00811239, which also lists 7 linked publications.
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 18 Dec 2008.