Swiss Study on Spider Bites | NCT01355744

Studies
Swiss Study on Spider Bites

NCT01355744

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 7, 2013Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Spider Bite

Interventions

Not provided

Countries

Switzerland

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

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

May 17, 2011

First Posted Date

May 18, 2011Estimated

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

Oct 1, 2013

Last Update Posted Date

Oct 7, 2013Estimated

Name	Class
University of Bern	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

About spider bites in Middle Europe, there are published only a dozen cases. The investigators suspect that they may be much more frequent than reflected by the literature analysis (but much less dangerous than thought by people). From June 1st 2011 to November 30st 2012 the investigators collect clinical data on patients treated for spider bites in Switzerland.

Detailed Description

Inclusion criteria: Every human treated for suspected spider bite in Switzerland willing to participate this study.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spider bite patients		All patients treated for an actual spider bite by a Swiss physician during study period.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical follow up of bite lesions.	Clinical evolutions of actual spider bite lesions in humans are observed.	14 days (or more if necessary)

Secondary Outcomes

Measure	Description	Time Frame
Time spread of spider bites	Frequencies of spider bites over the study period of 18 months are observed.	18 months
Causative animals	To determine spider species causing bites in Switzerland by sending spider specimens to an expert arachnologist.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult or child treated for a suspected spider bite in Switzerland

Exclusion Criteria:

unwillingness to participate to the study

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

Every person with a suspected spider and treated by a Swiss Physician.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus P. Gnädinger, MD	Department of General Practice University Hospital Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Praxis Dr. med. Markus Gnaedinger		Steinach	Canton of St. Gallen	9323	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24019004	Derived	Gnadinger M, Nentwig W, Fuchs J, Ceschi A. Swiss prospective study on spider bites. Swiss Med Wkly. 2013 Sep 4;143:w13877. doi: 10.4414/smw.2013.13877. eCollection 2013.

ID	Term
D001098	Spider Bites
D007299	Insect Bites and Stings

ID	Term
D001733	Bites and Stings
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries