AScVS and/ or Prazosin for Scorpion Envenomation

NCT00753064 | Completed Phase 3

• 1 other identifier: AScVS vs Prazosin
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Scorpion Envenomation

Keywords

Red Scorpion envenomation; Composite clinical scoring system; AScVS; Prazosin; Superiority

Outcome Measures

Primary Outcomes (1)

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

  1year 4 months.

Study Arms (3)

AScVS

ACTIVE COMPARATOR

a 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.

Drug: Antiscorpion venom serum(AScVS).

Prazosin.

ACTIVE COMPARATOR

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.

Drug: T.Prazosin

AScVS + Prazosin

ACTIVE COMPARATOR

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.

Drug: AScVS + Prazosin

Interventions

Antiscorpion venom serum(AScVS). DRUG

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

Also known as: AScVS(Haffkine)

AScVS

T.Prazosin DRUG

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.

Also known as: T.Prazosin (sun pharma)

Prazosin.

AScVS + Prazosin DRUG

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.

Also known as: AScVS (Haffkine), T. Prazosin (sun pharma)

AScVS + Prazosin

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Generalized sweating with rigors and cold extremities.
• Gen.profuse sweating,wetting of clothes and cold clammy skin.
• Pulse rate 0 70- 90
• or \< 70
• or \< 60 or irreg pulse
• \> 160
• Respiratory rate 0 \< 20
• without crepitations
• with crepitations

You may not qualify if:

• 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

Sponsors & Collaborators

• Haffkine Bio-Pharmaceutical Corporation Ltd.: lead

Study Sites (5)

Kushte Hospital

Chiplūn, Maharashtra, 415605, India

Location

Natu Hospital

Chiplūn, Maharashtra, 415605, India

Location

Sane Hospital

Chiplūn, Maharashtra, 415605, India

Location

Mangaon cottage hospital, Mangaon.

Dist. Raigad., Maharashtra, 402104, India

Location

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

Dist. Ratnagiri., Maharashtra, 415702, India

Location

MeSH Terms

Conditions

Scorpion Stings

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr Vivek S Natu, M.S.

  Vijayshree Hospital, Umroli, Chiplun, Ratnagiri, Maharashtra, India.

  PRINCIPAL INVESTIGATOR

• Dr. Santosh Kamerkar, M.S

  Cottage Hospital Mangaon,Raigad,Maharashtra, India

  STUDY CHAIR

• Dr. Geeta Kadam, M.B.B.S.

  Cottage Hospital Mangaon,Raigad,Maharashtra, India

  STUDY CHAIR

• Dr. Vidya Kamble, M.B.B.S.

  Cottage Hospital Mangaon,Raigad,Maharashtra, India

  STUDY CHAIR

• Dr. Vikas Natu, MBBS DCH

  Natu Hospital Chiplun,Ratnagiri, Maharashtra,India

  STUDY CHAIR

• Dr. Sanjeev Sane, MBBS DCH

  Sane Hospital Chiplun,Ratnagiri, Maharashtra,India

  STUDY CHAIR

• Dr. Rajesh Kushte, MBBSDCH

  Kushte Hospital Chiplun,Ratnagiri, Maharashtra,India

  STUDY CHAIR

• Dr. Sunil Thatte, M.D.

  Attending physician at Natu, Sane & Kushte Hospital Chiplun,Ratnagiri, Maharashtra,India

  STUDY CHAIR

• Dr. Uchil Dinesh, Ph.D.

  A.R.C. K.E.M. Hospital Mumbai,Maharashtra,India

  STUDY CHAIR

• Dr. Nirmala Rege, M.D.

  A.R.C. K.E.M. Hospital Mumbai,Maharashtra,India

  STUDY CHAIR

• Dr. Ravindra Bapat, M.S.

  K.E.M. Hospital Mumbai,Maharashtra,India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2008
• First Posted: September 16, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 16, 2008

Record last verified: 2008-09

Locations

IN (5)