Viral InfectionMKUNCT02605109
Analysis of Human to Human Transmission of Middle East Respiratory Syndrom Coronavirus (MER-CoV)
An observational study of Viral Infection, run by Konkuk University Medical Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Viral Infection
- What is being tested?
- Risk of MERS infection
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pesons who had the risk of MERS transmission from the case-patient
Who may be able to join
- All aged persons who have risk of MERS transmission from a case-patients
Who cannot join
- No risk of transmission
About this study
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
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.
Read the 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.
- Conditions
- Viral Infection
- Being tested
- Risk of MERS infection
- Keywords
- MERS-CoV, Infection control, Case-control studies
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk of MERS infectionOther
HCPs, patients and layperson to closely or indirectly contact a case-patients
| Study group | Role | What they receive |
|---|---|---|
| RiskMERS | Exposed to case-patients Receives: Other: Risk of MERS infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of infected patient
Measured: Serologic confimred MERS case within 4 weeks after contacting to a case patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang O, Park, Konkuk University Medical Center
- Investigators
- Hyun Kyun Ki, MD, Study director, Devision of Infection, Department of Medicine, School of Medicine, Konkuk University, Seoul 143-729, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605109
- Sponsor's protocol ID
- MERSKORKUH
- Acronym
- MKU
- Status last verified
- Aug 2016
- First submitted
- 11 Nov 2015
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 25379596Oh 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.
PubMed 26539018Yang 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.
PubMed 26488745Korean 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.
PubMed 26157591Gostin 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. No abstract available.
PubMed 26084030Zumla 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.
PubMed 26049252Kayali 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. No abstract available.
PubMed 25863563Ki HK, Han SK, Son JS, Park SO. Risk of transmission via medical employees and importance of routine infection-prevention policy in a nosocomial outbreak of Middle East respiratory syndrome (MERS): a descriptive analysis from a tertiary care hospital in South Korea. BMC Pulm Med. 2019 Oct 30;19(1):190. doi: 10.1186/s12890-019-0940-5.
PubMed 31666061
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02605109
- Acronym / sponsor ID
- MKU / MERSKORKUH
- Conditions
- Viral Infection
- Keywords
- MERS-CoV, Infection control, Case-control studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RiskMERS | – | Other: Risk of MERS infectionExposed to case-patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pesons who had the risk of MERS transmission from the case-patient
Key inclusion criteria (1 listed)
- All aged persons who have risk of MERS transmission from a case-patients
Key exclusion criteria (1 listed)
- No risk of transmission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk of MERS infectionHCPs, patients and layperson to closely or indirectly contact a case-patients | Other | RiskMERS |
Primary outcome
Numbers of infected patient
Time frame: Serologic confimred MERS case within 4 weeks after contacting to a case patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Background: PubMed 25379596Cetra 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.
- Background: PubMed 26539018Oh 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.
- Background: PubMed 26488745Yang 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.
- Background: PubMed 26157591Korean 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.
- Background: PubMed 26084030Gostin 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. No abstract available.
- Background: PubMed 26049252Zumla 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.
- Results publication: PubMed 25863563Kayali 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. No abstract available.
- Derived from this study: PubMed 31666061Ki HK, Han SK, Son JS, Park SO. Risk of transmission via medical employees and importance of routine infection-prevention policy in a nosocomial outbreak of Middle East respiratory syndrome (MERS): a descriptive analysis from a tertiary care hospital in South Korea. BMC Pulm Med. 2019 Oct 30;19(1):190. doi: 10.1186/s12890-019-0940-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Kyun Ki, MD study director
Devision of Infection, Department of Medicine, School of Medicine, Konkuk University, Seoul 143-729, Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Infection, run by Konkuk University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of infected patient (time frame: Serologic confimred MERS case within 4 weeks after contacting to a case patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605109, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.