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Scorpion EnvenomationPhase 3NCT00753064

AScVS and/ or Prazosin for Scorpion Envenomation

A Phase 3 study testing Antiscorpion venom serum(AScVS)., T.Prazosin and AScVS + Prazosin in people with Scorpion Envenomation, run by Haffkine Bio-Pharmaceutical Corporation Ltd. at 5 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Scorpion Envenomation
What is being tested?
Antiscorpion venom serum(AScVS)., T.Prazosin and AScVS + Prazosin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
5 sitesIndia
Study dates
Sep 2006to Dec 2007
Phase
Phase 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 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients of both sexes, in the age range of 12-65 years
  • reporting to the PHC/ hospital within 48 hours of scorpion sting and
  • associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the criteria below:)
  • Criteria Grade Symptoms
  • Sweating 0 Limited to the extremity of the sting site.
  • Minimal sweating all over the body, slight nasal secretions
Show all 34Show fewer
  • Generalized sweating with rigors and cold extremities.
  • Gen.profuse sweating,wetting of clothes and cold clammy skin.
  • Pulse rate 0 70- 90
  • 91 - 100
  • 101 - 120 or < 70
  • 121 - 140 or < 60 or irreg pulse
  • 141 - 160
  • > 160
  • Respiratory rate 0 < 20
  • 20 - 30
  • 31 - 40 without crepitations
  • 31 - 40 with crepitations
  • > 40 with crepitations
  • > 40 with crepitations and cyanosis
  • Blood pressure 0 120/80
  • Systolic: 121 -140 and diastolic: 81 -90
  • Systolic: 141 -160 and diastolic: 91-100
  • Syst: 161 -180 and diast: 101-110 Or syst <100
  • Syst: 181 -200 and diast: 111-120 Or syst <100
  • Syst: > 200 and diast: >120 Or syst < 60
  • CNS effects 0 No sensory involvement
  • Minimal tingling numbness around mouth
  • Tingling, numbness around mouth and giddiness
  • Altered sensorium, patient roudy
  • Patient semiconscious
  • Patient unconscious
  • Priapism 2 Slight erection 3 Strong erection
  • To obtain a composite score, grades for individual criterion will be added. Maximum score: 25 and minimum score: 0

Who cannot join

  • Composite score less than 5 and greater than 21.
  • Grade of 5 in any of the criterion
  • Severe Pulmonary edema with oxygen saturation below 80%.
  • Severe scorpion envenomation with reporting time more than 2 days
  • Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc.
  • Severe anaphylactic reaction to any of the study drugs
  • Patient (or relative in case of child) not willing to participate

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

India5 sites
  • Kushte Hospital

    Chiplūn, Maharashtra, 415605

  • Natu Hospital

    Chiplūn, Maharashtra, 415605

  • Sane Hospital

    Chiplūn, Maharashtra, 415605

  • Mangaon cottage hospital, Mangaon.

    Dist. Raigad., Maharashtra, 402104

  • Vijayshree Hospital,At & Po.Umroli,Tal. Chiplun.

    Dist. Ratnagiri., Maharashtra, 415702

Other trials in India

About this study

Official title: Comparative Study of Efficacy of Antiscorpion Venom Serum(AScVS)vs Prazosin in the Management of Severe Scorpion(Mesobuthus Tamulus Concanesis Pocock)Envenomation and Evaluation of Effects of the Combination of AScVS + Prazosin Therapy.

The data available for the efficacy of AScVS and prazosin is generated through different trials done in different clinical setting. Hence it was felt worthwhile to confirm the documented efficacy of AScVS and prazosin in terms of time taken for clinical recovery in a clinical trial. Along with this, effects of both the therapies on various biochemical parameters will be recorded and compared with. It was also felt necessary to study the effect of combination on the clinical outcome.

Read the detailed description

Red Scorpion (Mesobuthus Tamulus Concanesis Pocock) sting is a common medical emergency in the coastal regions of India and is a cause for considerable morbidity and mortality.

Signs and symptoms show either cholinergic or adrenergic predominance. Cholinergic symptoms are profuse sweating, priapism, bradycardia, increased salivary and bronchial secretions and vomiting. Adrenergic symptoms are transient hypertension followed by hypotension, tachycardia, tachypnoea, pulmonary edema and circulatory failure in later stages. Scorpion venom blocks voltage dependent inactivation of sodium channels, resulting in intense persistent voltage depolarization of autonomic nerves with massive release of catecholamines from adrenal medulla and parasympathetic and sympathetic nerve endings.

Prazosin a selective alpha-1 blocker is used as the treatment for scorpion sting, which can only counteract the manifestations of sympathetic over-activity. Experimentally and clinically it is seen that scorpion venom stays in the body for 24-36 hours, as Prazosin does not neutralize the venom, 3 hourly round the clock doses of prazosin and continuous I.C.U. monitoring is necessary with alpha blocker therapy. However, ideal treatment modality remains neutralization of venom in the systemic circulation.

Since 1997 enzyme refined AScVS ( Monovalent Anti-scorpion venom serum against Mesobuthus tamulus concanesis Pocock.) has been made available by Haffkine Biopharmaceuticals, Mumbai for field use. Throughout the konkan(western coastal Maharashtra, India) area the same species of scorpions responsible for fatal envenomation is found.

From 1997-2002, 48 patients of serious scorpion envenomation were treated with AScVS(1). Based on this experience a clinical scoring system for dose requirement was evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. In our experience computed doses given as intravenous bolus are more effective and successfully ameliorated signs and symptoms in all patients. Subsequently 16 patients were given treatment with either AScVS (n=8), Prazosin (n=5) and a combination of both (n=3) so as to compare the effects of these available treatment modalities. It was found that the patients receiving either AScVs or a combination showed a complete recovery approximately within 4 hours of onset of therapy as against patients receiving Prazosin, who required 16 hours for recovery. There was no mortality in any of the group. There was not a single incidence of anaphylaxis after administration of AScVS. Release of adrenaline in the systemic circulation by scorpion sting itself appears to be protective against the danger of anaphylaxis. The label on the AScVS vials states that the maximum dose is 3 vials, which can be given either intramuscular or by intravenous route. However we used AScVS as slow bolus intravenously and dose was decided clinically depending upon the severity of the patient condition. (maximum 10-15vials.) Based on this experience, an open labeled, randomized controlled parallel group clinical trial has been initiated. Eighty-three patients have been recruited so far, 28 patients each, in AScVS and AScVS + prazosin group and 27 patients in Prazosin group, two patients out of 27 in Prazosin group were withdrawn as both the pediatric patients (around 12 years old) developed pulmonary edema after few hours, so AScVS had to be given. The onset of relief (based on composite score) with AScVS or combination of AScVS with prazosin was early and complete recovery occurred at 4.14+/- 1.6 hrs. and 3.46+/- 1.10hours. However, in patients receiving only prazosin, the clinical score was found to worsen initially, followed by a gradual improvement and subsequent complete recovery, at 19.28 +/- 5.03 hrs. (p<0.001 vs AScVS). Recovery time with AScVS is much shorter because after complete neutralization of venom, fresh secretion of catecholamines stop and adrenaline and nor-adrenaline which are already in circulation have action as short as 1 to 2 minutes. These findings appear consistent with our clinical experience and indicate that in the near future AScVS would evolve as a safe, efficacious and life saving treatment modality for patients with severe scorpion envenomation. Use of clinical scoring system can enable the clinician to select the optimum dose of AScVS to be administered.

Neutralization of venom is thus proved to be better than therapy for complications, akin to the dictum 'prevention is better than cure'.

References:

  1. Natu VS, Murthy RKK, Deodhar KP. Efficacy of species specific Antiscorpion venom serum (AScVS) against severe, serious scorpion stings (mesobuthus tamulus concanesis pocock.)-An experience from rural hospital in western Maharashtra. JAPI, 2006; 54: 283-7.
Being tested
Antiscorpion venom serum(AScVS)., T.Prazosin, AScVS + Prazosin
Keywords
Red Scorpion envenomation, Composite clinical scoring system, AScVS, Prazosin, Superiority
Medical subject headings
Scorpion Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiscorpion venom serum(AScVS).Drug

    Also called AScVS(Haffkine)

    AScVS therapy group

    If the score is 5 and if the patient belongs to pediatric group(>12-14): 1 vial AScVS as i.v. slow bolus after test dose If the score is 5 and if the patient is adult: 2 vials of AScVS as i.v. slow bolus after test dose. For injection, 1 vial will be dissolved in 10 ml distilled water and given over a period of 4 to 5 minutes.

    According to the scores 1 vial for pediatric and 2 vials for adult patient will be increased as shown below:

    Vials of AScVS Composite score Child Adult 5-10 2 4 > 10-15 3 6 >15- 21 4 8

  • T.PrazosinDrug

    Also called T.Prazosin (sun pharma)

    Prazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery.

  • AScVS + PrazosinDrug

    Also called AScVS (Haffkine), T. Prazosin (sun pharma)

    Combination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin(500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.

Study groups in NCT00753064
Study groupRoleWhat they receive
AScVSActive comparatora clinical scoring system for dose requirement for AScVS is evolved based on sweating, pulse rate, respiratory rate, blood pressure, CNS effects and presence of priapism. Computed doses were given according to clinical grading as intravenous bolus slowly.
Receives: Drug: Antiscorpion venom serum(AScVS).
Prazosin.Active comparatorPrazosin therapy Prazosin (30 micrograms/Kg/dose): 500 micrograms for pediatric patient, and 1mg for adult patients) will be given every 3 hourly orally till complete recovery.
Receives: Drug: T.Prazosin
AScVS + PrazosinActive comparatorCombination AScVS and Prazosin therapy In this group, AScVS therapy will be given as mentioned in AScVS therapy group and in addition, prazosin (500 micrograms for pediatric patient and 1mg for adult patients,30 micrograms/Kg/dose) every 3 hourly will be given.
Receives: Drug: AScVS + Prazosin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone.

    Measured: 1year 4 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00753064
Sponsor's protocol ID
AScVS vs Prazosin
Status last verified
Sep 2008
First submitted
14 Sep 2008
Last updated
16 Sep 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Antiscorpion venom serum(AScVS)., T.Prazosin and AScVS + Prazosin in people with Scorpion Envenomation, run by Haffkine Bio-Pharmaceutical Corporation Ltd. at 5 sites in India.

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 34 inclusion and 7 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 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in India. 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 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?

Superiority of AScVS and AScVS+Prazosin was confirmed over use of Prazosin alone. (time frame: 1year 4 months.). 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 16 Sep 2008.

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