A Phase 2 interventional study of Antivenom in Snake Bite, sponsored by CTU. Completed at 3 sites in Nepal. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2017-02-07.
Sponsored by CTU · Phase 2, Interventional, and Treatment
This study aims at comparing two doses of antivenom in the treatment of snake bite envenoming. It will take place in 3 centers in rural Nepal and will involve 250 snake bite victims presenting with one or more sign of neurotoxic envenoming. The objective of the study is to generate enough scientific evidence to improve Nepal's current national guidelines for the management of snake bites.
Snake bites are considered as one of the major neglected public health issues of tropical areas. They occur chiefly in developing countries and mainly affect poor rural communities. Besides the inadequate supply, distribution and accessibility of antivenom, a major problem is the absence of standardized and adequate treatment protocol. There is a significant diversity in clinical practices, in particular concerning the dose of antivenom given. Additionally, antivenom is often given even in the absence of a clear indication for envenoming. Altogether, this leads to an incredible waste of a scarce and costly resource.
In Nepal there are gross disparities in the management and outcomes of snake bite envenoming. The country's national guidelines, issued in 2004, prescribe an initial antivenom dose that is 5 times less than the one advocated by most experts. The dosage recommended by the National guidelines is not based on scientific or clinical evidence, and currently, there is confusion about the adequate dose to be administered. Some physicians follow recommendations published by experts, others follow the National guidelines, but for most, dosage is arbitrary. These discrepancies directly impact on morbidity and mortality and lead to wastage of a costly treatment that few can afford.
The principal objective of the study is to establish unequivocally which dosage regimen is the most appropriate for the treatment of snake bite neurotoxic envenoming. It is a randomized, double-blind, clinical trial comparing high and low initial doses of snake polyvalent antivenom also known as Anti Snake Venom Serum (ASVS). 250 snake bite victims showing signs of neurotoxic envenoming will be enrolled over 2 years in three health centres of Southern Nepal. Each participant will initially receive either 2 vials or 10 vials of snake polyvalent antivenom. Mortality, the proportion of patients needing assisted respiration, and the percentage of patients who show worsening of neurotoxic signs and therefore require additional doses of antivenom will be compared in both arms. The kinetics of recovery and the total consumption of antivenom will also be compared. Finally, the incidence and severity of early and late adverse reactions to antivenom will be assessed. The economical impact of snake bite envenoming will also be determined by measuring direct and indirect costs to both health services and individual victims. Because they chiefly affect agricultural workers and children, snake bites have serious economic consequences, a fact that is frequently overlooked by national authorities.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's planned enrollment of 250 is above the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →CTU is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arms corresponds to Nepal national protocol and involves the initial administration of 2 vials of antivenom over one hour followed by the slow infusion of 4 vials over 4 hours
Drug: Antivenom
This arms corresponds to Indian national protocol and involves the initial administration of 10 vials of antivenom over one hour followed by the slow infusion of saline over 4 hours
Drug: Antivenom
Polyvalent antivenom directed against Indian spectacled cobra (N. naja), common Indian krait (B. caeruleus), saw-scaled viper (Echis carinatus) and Russell's viper.
Also known as: VINS Bioproduct
Composite endpoint: Number of patients who either 1) died, or 2) needed assisted ventilation, or 3) showed a worsening of envenoming signs during hospital stay
The endpoint is composite and includes the number of patients who * die during hospitalization * are put under assisted ventilation during hospitalization * necessitate additional doses of antivenom because of a worsening of neurotoxicity. A worsening of neurotoxicity will be defined as the appearance of 2 new neurotoxic signs OR the appearance of a severe neurotoxic sign (i.e. loss of gag reflex or paradoxical breathing)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of patients with a Serious Adverse Events
Time frame: Last follow-up visit (6 months after randomization)
Mortality
Number of deaths
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Total amount of antivenom administered
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Time to recovery
Time between admission to the health centre and the disappearance of all neurotoxic sign s
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Total cost of treatment
Including direct (antivenom and other drugs costs, costs of hospitalization, and costs of Adverse Events management)and indirect costs (working days missed)
Time frame: Last follow-up visit (6 months after randomization)
Number of patients with Adverse Events
Time frame: Last follow-up visit (6 months after randomization)
Number of patients who needed assisted ventilation during hospitalization
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of patients who showed a worsening of neurotoxicity during hospitalization
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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