Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study

NCT03862092 | Completed DMC

• 1 other identifier: 2014-1186
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to identify the frequency of enteric zoster using salivary varicella zoster virus (VZV) DNA PCR in patients who visit the emergency room due to acute abdominal pain.

Conditions

Abdominal Pain; Zoster With Other Complications

Keywords

varicella zoster virus; enteric zoster; saliva

Outcome Measures

Primary Outcomes (1)

• Frequency of enteric zoster in patients with acute abdominal pain

  The frequency of putative enteric zoster in patients with acute abdominal pain regardless of their underlying diseases

  At the time of enrolled.

Study Arms (1)

Patients with acute abdominal pain

EXPERIMENTAL

Salivary VZV-DNA PCR was performed in patients who visited the emergency room due to acute abdominal pain.

Diagnostic Test: Salivary VZV-DNA PCR

Interventions

Salivary VZV-DNA PCR DIAGNOSTIC_TEST

VZV-DNA PCR of saliva samples

Patients with acute abdominal pain

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18, and \< 80 years
• ER-visited patients with acute abdominal pain
• Numerical rating scale (NRS) score ≥ 4
• Unresponsive to gastrointestinal motility drug, antacid

You may not qualify if:

• Unwilling or unable to give informed consent forms
• Patients taking antiviral agents
• Patients complaining mild abdominal pain (NRS score ≤ 3)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Related Publications (9)

• Zerboni L, Sen N, Oliver SL, Arvin AM. Molecular mechanisms of varicella zoster virus pathogenesis. Nat Rev Microbiol. 2014 Mar;12(3):197-210. doi: 10.1038/nrmicro3215. Epub 2014 Feb 10.

  PMID: 24509782 BACKGROUND

• Dworkin RH, Johnson RW, Breuer J, Gnann JW, Levin MJ, Backonja M, Betts RF, Gershon AA, Haanpaa ML, McKendrick MW, Nurmikko TJ, Oaklander AL, Oxman MN, Pavan-Langston D, Petersen KL, Rowbotham MC, Schmader KE, Stacey BR, Tyring SK, van Wijck AJ, Wallace MS, Wassilew SW, Whitley RJ. Recommendations for the management of herpes zoster. Clin Infect Dis. 2007 Jan 1;44 Suppl 1:S1-26. doi: 10.1086/510206.

  PMID: 17143845 BACKGROUND

• Gilden DH, Kleinschmidt-DeMasters BK, LaGuardia JJ, Mahalingam R, Cohrs RJ. Neurologic complications of the reactivation of varicella-zoster virus. N Engl J Med. 2000 Mar 2;342(9):635-45. doi: 10.1056/NEJM200003023420906. No abstract available.

  PMID: 10699164 BACKGROUND

• Gilden DH, Wright RR, Schneck SA, Gwaltney JM Jr, Mahalingam R. Zoster sine herpete, a clinical variant. Ann Neurol. 1994 May;35(5):530-3. doi: 10.1002/ana.410350505.

  PMID: 8179298 BACKGROUND

• Edelman DA, Antaki F, Basson MD, Salwen WA, Gruber SA, Losanoff JE. Ogilvie syndrome and herpes zoster: case report and review of the literature. J Emerg Med. 2010 Nov;39(5):696-700. doi: 10.1016/j.jemermed.2009.02.010. Epub 2009 Mar 27.

  PMID: 19327938 BACKGROUND

• Gershon AA, Gershon MD. Pathogenesis and current approaches to control of varicella-zoster virus infections. Clin Microbiol Rev. 2013 Oct;26(4):728-43. doi: 10.1128/CMR.00052-13.

  PMID: 24092852 BACKGROUND

• Mehta SK, Tyring SK, Gilden DH, Cohrs RJ, Leal MJ, Castro VA, Feiveson AH, Ott CM, Pierson DL. Varicella-zoster virus in the saliva of patients with herpes zoster. J Infect Dis. 2008 Mar 1;197(5):654-7. doi: 10.1086/527420.

  PMID: 18260763 BACKGROUND

• Park SY, Kim JY, Kim JA, Kwon JS, Kim SM, Jeon NY, Kim MC, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Kim SH. Diagnostic Usefulness of Varicella-Zoster Virus Real-Time Polymerase Chain Reaction Analysis of DNA in Saliva and Plasma Specimens From Patients With Herpes Zoster. J Infect Dis. 2017 Dec 27;217(1):51-57. doi: 10.1093/infdis/jix508.

  PMID: 29029120 BACKGROUND

• Ra SH, Kwon JS, Kim JY, Cha HH, Lee HJ, Jung J, Kim MJ, Chong YP, Lee SO, Choi SH, Kim YS, Kim WY, Kim SH. Frequency of putative enteric zoster diagnosed using saliva samples in patients with abdominal pain: a prospective study. Infect Dis (Lond). 2021 Sep;53(9):713-718. doi: 10.1080/23744235.2021.1908593. Epub 2021 Apr 8.

  PMID: 33830871 DERIVED

MeSH Terms

Conditions

Abdominal Pain; Chickenpox

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Sung-Han Kim, MD.PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 5, 2019
• Study Start: April 24, 2019
• Primary Completion: November 19, 2019
• Study Completion: December 31, 2019
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)