Analysis of Human to Human Transmission of Middle East Re... | NCT02605109

Studies
Analysis of Human to Human Transmission of Middle East Respiratory Syndrom Coronavirus (MER-CoV)

NCT02605109

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Sep 1, 2016Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Viral Infection

Interventions

Risk of MERS infection

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

Aug 2016

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 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Nov 11, 2015

First Submission Date that Met QC Criteria

Nov 12, 2015

First Posted Date

Nov 16, 2015Estimated

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

Aug 30, 2016

Last Update Posted Date

Sep 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sang O, Park, Assistant Professor, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study aimed to analysis the characteristics of MERS transmission and the effect of our institutional personal protective equipment on the controlling the MERS at a tertiary Korean Hospital.

Detailed Description

Between May 2015 and Nov 2015, total 186 cases of MERS-Cov infections were reported in South Korea. In June 2015, a female patient visited our emergency department (ED) for care of femur fracture. She was suspected of having MERS-Cov and isolated after 10 hours from the visit of our hospital because her clinical feature was not concordance with typical MERS-Cov infection and she denied the any contact of MERS-Cov patient. Before the transport to the isolation room, she stayed at ED during 8 hours, and admitted the general ward during 2 hours. Approximately 150 including the healthcare providers, patients and laypersons were exposed to the case-patient directly or indirectly. The investigators monitored all possible contacts in the hospital during that time, and analysed the CCTV data of hospital and interviewed all risk-persons. After the hospital outbreak ended, The investigators analysed the data of all behavior and contact history of MERS patient, epidermic and clinical data of infected patients and data of personal protective equipments (PPE) of all exposed persons.

Descriptive analysis were conducted for basic epidemiology, transmission rout of MERS in hospital, and the effect of hospital infection control system and PPE of each contacts.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RiskMERS		Exposed to case-patients	Other: Risk of MERS infection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risk of MERS infection	Other	HCPs, patients and layperson to closely or indirectly contact a case-patients	RiskMERS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numbers of infected patient		Serologic confimred MERS case within 4 weeks after contacting to a case patients

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All aged persons who have risk of MERS transmission from a case-patients

Exclusion Criteria:

No risk of transmission

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

pesons who had the risk of MERS transmission from the case-patient

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyun Kyun Ki, MD	Devision of Infection, Department of Medicine, School of Medicine, Konkuk University, Seoul 143-729, Korea	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25379596	Background	Cetra A. MERS-CoV update: what you need to know. Lancet Infect Dis. 2014 Oct;14(10):924-5. doi: 10.1016/s1473-3099(14)70930-2. No abstract available.
26539018	Background	Oh MD, Choe PG, Oh HS, Park WB, Lee SM, Park J, Lee SK, Song JS, Kim NJ. Middle East Respiratory Syndrome Coronavirus Superspreading Event Involving 81 Persons, Korea 2015. J Korean Med Sci. 2015 Nov;30(11):1701-5. doi: 10.3346/jkms.2015.30.11.1701. Epub 2015 Oct 16.