NCT02040350

Brief Summary

To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

January 9, 2014

Last Update Submit

January 16, 2014

Conditions

Deaths

Keywords

Pralidoxime, atropine, organophosphorous poisoning.

Outcome Measures

Primary Outcomes (1)

  • mortality rate

    upto one year

Secondary Outcomes (1)

  • duration of ventilation

    upto one year

Other Outcomes (1)

  • duration of ICU stay

    upto one year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo was given to compare the effects

Drug: Pralidoxime

Pralidoxime

ACTIVE COMPARATOR

Pralidoxime for treating organophosphorous poisoning patients

Drug: Pralidoxime

Interventions

PralidoximeDRUG

Pralidoxime was compared to placebo to study the effects of the drug on mortatlity

Also known as: Oximes
PlaceboPralidoxime

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • history of alleged organophosphorus intake age \> 14 years \< 60 years clinical signs and symptoms of organophosphorus poisoning.

You may not qualify if:

  • \< 14 years or \> 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses
  • ≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheri kashmir insititute of medical sciences

Srinagar, Srinagar Kashmir, 190006, India

Location

Related Publications (1)

  • Eddleston M, Buckley NA, Eyer P, Dawson AH. Management of acute organophosphorus pesticide poisoning. Lancet. 2008 Feb 16;371(9612):597-607. doi: 10.1016/S0140-6736(07)61202-1.

    PMID: 17706760BACKGROUND

MeSH Terms

Conditions

Death

Interventions

pralidoximeOximes

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxylaminesAminesOrganic Chemicals

Study Officials

  • Showkat Gurcoo, MD

    SKIMS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registar

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 20, 2014

Study Start

April 1, 2012

Primary Completion

August 1, 2013

Study Completion

November 1, 2013

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

IN(1)