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NCT02605109 Clinical Trial

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

Viral Infection Clinical Trial

— MKU  

Official title:
Analysis of Human to Human Transmission of Middle East Respiratory Syndrom Coronavirus (MER-CoV) and Infection Control Experiences in a Medical Institution of South Korea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02605109
Other study ID # MERSKORKUH
Secondary ID
Status Completed
Phase N/A
First received November 11, 2015
Last updated August 30, 2016
Start date June 2015
Est. completion date November 2015

Study information
Verified date August 2016
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Konkuk University Medical Center
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- No risk of transmission

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Risk of MERS infection
HCPs, patients and layperson to closely or indirectly contact a case-patients

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

References & Publications (7)

Cetra A. MERS-CoV update: what you need to know. Lancet Infect Dis. 2014 Oct;14(10):924-5. — View Citation

Gostin LO, Lucey D. Middle East Respiratory Syndrome: A Global Health Challenge. JAMA. 2015 Aug 25;314(8):771-2. doi: 10.1001/jama.2015.7646. — View Citation

Kayali G, Peiris M. A more detailed picture of the epidemiology of Middle East respiratory syndrome coronavirus. Lancet Infect Dis. 2015 May;15(5):495-7. doi: 10.1016/S1473-3099(15)70128-3. Epub 2015 Apr 8. — View Citation

Korean Society of Infectious Diseases; Korean Society for Healthcare-associated Infection Control and Prevention. An Unexpected Outbreak of Middle East Respiratory Syndrome Coronavirus Infection in the Republic of Korea, 2015. Infect Chemother. 2015 Jun;47(2):120-2. doi: 10.3947/ic.2015.47.2.120. Epub 2015 Jun 30. — View Citation

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. — View Citation

Yang JS, Park S, Kim YJ, Kang HJ, Kim H, Han YW, Lee HS, Kim DW, Kim AR, Heo DR, Kim JA, Kim SJ, Nam JG, Jung HD, Cheong HM, Kim K, Lee JS, Kim SS. Middle East Respiratory Syndrome in 3 Persons, South Korea, 2015. Emerg Infect Dis. 2015 Nov;21(11):2084-7. doi: 10.3201/eid2111.151016. — View Citation

Zumla A, Hui DS, Perlman S. Middle East respiratory syndrome. Lancet. 2015 Sep 5;386(9997):995-1007. doi: 10.1016/S0140-6736(15)60454-8. Epub 2015 Jun 3. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Numbers of infected patient Serologic confimred MERS case within 4 weeks after contacting to a case patients Yes
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