Microbiological Keratitis in a Countryside City of Brazil | NCT00949468

Studies
Microbiological Keratitis in a Countryside City of Brazil

NCT00949468

Sponsor

Sao Jose do Rio Preto Medical School

Status

Completed

Last Update Posted

Jul 30, 2009Estimated

Enrollment

74Actual

Phase

Not provided

Conditions

Keratitis

Interventions

Not provided

Countries

Brazil

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

Jul 2009

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 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 29, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 30, 2009Estimated

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

Jul 29, 2009

Last Update Posted Date

Jul 30, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sao Jose do Rio Preto Medical SchoolOTHER

Collaborators

Name	Class
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

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 purpose of this study is to identify the predisposing factors, epidemiological features and clinical and microbiological diagnosis of infectious keratitis in two public referral centers of ophthalmology in a countryside city of Brazil.

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

Retention

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Keratitis group		37 patients with keratitis
Control Study Group		37 control volunteers

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted with clinical suspicious of keratitis from June 2008 to June 2009 (Keratitis group)
37 volunteers without any ophthalmologic claim, recruited in the two ophthalmology centers listed (Control study group)

Exclusion Criteria:

In the Control Study Group, no infectious ocular disease was accepted

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

37 patients admitted in two referral ophthalmology centers in a countryside city of Brazil. 37 volunteers were used as a control group.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thiago Lo Genaro, Academic	Sao Jose do Rio Preto Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sao Jose do Rio Preto University		São José do Rio Preto	São Paulo	15090000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007634	Keratitis

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided