Laboratory Diagnosis of of Rickettsial and Rickettsia-lik... | NCT01137175

Studies
Laboratory Diagnosis of of Rickettsial and Rickettsia-like Diseases

NCT01137175

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Unknown status

Last Update Posted

Oct 1, 2012Estimated

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Rickettsioses

Interventions

Not provided

Countries

Taiwan

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 3, 2010

First Submission Date that Met QC Criteria

Jun 3, 2010

First Posted Date

Jun 4, 2010Estimated

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

Sep 28, 2012

Last Update Posted Date

Oct 1, 2012Estimated

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

The low confirmed rickettsioses cases rate may indicate the presence of rickettsiosis other than scrub typhus, murine typhus, and Q fever. The clinical presentation of rickettsiosis is variable and atypical that laboratory confirmation is necessary. This project is aimed to set up the laboratory to diagnose rickettsial and rickettsial like disease, which could help in develop rapid diagnostic kits, epidemiologic surveillance and prognostic factor.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

4,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rickettsioses reported cases

Accepts Healthy Volunteers

Yes

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

patients suspect to be infected by Rickettsia pathogen

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jessie Jou, Assistant	Contact	886-7-3121101	6361	r93445113@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Chung-Ho Memorial Hospital	Recruiting	Kaohsiung City	Kaohsiung	807	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012282	Rickettsia Infections
D012612	Scrub Typhus
D011778	Q Fever
D014437	Typhus, Endemic Flea-Borne
D000073605	Spotted Fever Group Rickettsiosis

Ancestor Terms

ID	Term
D012288	Rickettsiaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided