Rabies Treatment by Exposure of Patient to X-Ray | NCT04261322

Studies
Rabies Treatment by Exposure of Patient to X-Ray

NCT04261322

Sponsor

National Institute For Research On Endemic Diseases And Liver, Egypt

Status

Unknown status

Last Update Posted

Feb 18, 2020Actual

Enrollment

4Estimated

Phase

Early Phase 1

Conditions

Treatment of Rabies

Interventions

x ray exposure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2020Estimated

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Jan 13, 2020

First Submission Date that Met QC Criteria

Feb 6, 2020

First Posted Date

Feb 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2020

Last Update Posted Date

Feb 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Samir Mohammed El Behwashy, Principal Investigator, National Institute For Research On Endemic Diseases And Liver, EgyptPrincipal Investigator

Lead Sponsor

National Institute For Research On Endemic Diseases And Liver, EgyptOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

x-ray has been proven to kill Rabies virus in vitro, so the investigators can use it in treatment of rabies infected patients.

Detailed Description

x-ray has been proven to kill Rabies virus in vitro, so the investigators can use it in treatment of rabies infected patients.

this can be done by exposure of infected , manifested patient who didn't receive prophylaxis or delayed in receiving immunoglobulins .

also can be applied to patients who have the injury in upper body near the CNS..

it's just an idea and the investigators need help to approve its effect and the investigators believe it will really work and give a new, rapid , cheap and very effective treatment to a 100% fatal disease..

the investigator also predict good results when x ray applied to some localized infections beside its current lines of treatment..

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rabies patient 1	Experimental	not received immunoglobulins and symptomatic	Radiation: x ray exposure
rabies patient 2	Experimental	received immunoglobulins and symptomatic	Radiation: x ray exposure
rabies patient 3	Experimental	not received immunoglobulins and not yet symptomatic	Radiation: x ray exposure
rabies patient 4	Experimental	received immunoglobulins and not symptomatic	Radiation: x ray exposure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
x ray exposure	Radiation	exposure of whole body to x ray	rabies patient 1 rabies patient 2 rabies patient 3 rabies patient 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of rabies infected, symptomatic patients who survived after x-ray exposure	detecting effect of x-ray exposure on treating Rabies	7 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient bitten by rabid animal with signs and symptoms

Exclusion Criteria:

bitten by non rabid animal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Samir El-Behwashy, fellowship	Contact	01001814806		ahmedelsamir@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided