Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture
Device Trial: Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture
1 other identifier
observational
12,550
1 country
15
Brief Summary
PCR detection of HSV DNA shedding in the female genital tract using the GeneXpert system (Cepheid, Sunnyvale CA) will be compared with traditional (routine) PCR (pregnant and nonpregnant women) and with HSV culture (nonpregnant women). The GeneXpert system performs all sample-processing steps and real-time PCR in a single integrated cartridge. The standard cartridge is an inexpensive disposable plastic cartridge with filtration and ultrasonic lysis capabilities. It consists chiefly of several combined molded plastic components: a cartridge body containing eleven fluid reservoirs or chambers along with an attached PCR tube, a specialized valve body with an ultrasonic interface containing a sub-micron filter and glass lysis beads, and a rotary valve with an axial syringe barrel. The operation of the cartridge is simple. The rotary valve contains an inlet and an outlet port. Fluid such as a sample buffer can be drawn up into a syringe drive through the inlet port of the rotary valve and then dispensed into any other chamber within the cartridge by rotating the valve and expelling the fluid through the outlet port. The fluid can either be passed through a filter contained within the valve assembly or it can be passed directly into the next chamber without filtration, depending on the path that is chosen. The cartridge fluidics and subsequent real-time PCR all are performed within the GeneXpert instrument. The GeneXpert contains multiple modules (ICORE units) that can be independently programmed to drive the syringe/rotary valve, and to perform four-color real-time PCR. Each cartridge fits inside one module, and all processing, PCR, and analysis steps are performed automatically. Each ICORE module can be run and analyzed independently, so batching of samples is unnecessary.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedResults Posted
Study results publicly available
September 9, 2020
CompletedSeptember 9, 2020
August 1, 2020
6 years
June 12, 2013
July 10, 2020
August 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sensitivity of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From the Genital Tract of Non-pregnant Women in STI Clinics, as Compared With HSV Culture
Assessing the vaginal specimen collected via a swab of non-pregnant women presenting to their provider at the time of active HSV outbreak with standard HSV culture compared to the assay of new device called a GeneXpert. Percent of GeneXpert assessment in agreement with standard HSV culture, for subjects who were positive for HSV according to culture.
on day of enrollment
Positive Percent Agreement of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From Genital Tract of Pregnant Women, as Compared With Routine PCR Detection of Viral DNA
Detection of HSV DNA by GeneXpert PCR compared to routine PCR detection by viral DNA. Percent of GeneXpert assessment in agreement with routine PCR detection, for subjects who are positive for HSV according to routine PCR.
DAY OF ENROLLMENT
Negative Percent Agreement of Detection of HSV DNA by GeneXpert PCR From Specimens Obtained From Genital Tract of Pregnant Women, as Compared With Routine PCR Detection of Viral DNA
Detection of HSV DNA by GeneXpert PCR compared to routine PCR detection by viral DNA. Percent of GeneXpert assessments in agreement with routine PCR detection, for subjects who were negative for HSV according to routine PCR.
DAY OF ENROLLMENT
Study Arms (2)
Non-pregnant women/active HSV lesions
Women presenting to local health department
Pregnant women/no active HSV lesions
Women presenting in active labor
Interventions
Eligibility Criteria
Pregnant and non-pregnant women
You may qualify if:
- ≥ 19 years of age
- Female gender
- In active labor with a viable fetus, OR non-pregnant and being evaluated in STI clinics for herpetic genital lesions
You may not qualify if:
- Receipt of acyclovir, valacyclovir, or famciclovir within the previous 14 days
- Known HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Louisiana State University Health Science Center-Shreveport
Shreveport, Louisiana, 71103, United States
Washington University in St Louis School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth Medical School
Lebanon, New Hampshire, 03756, United States
Steven & Alexandra Cohen Children's Medical Center of New York (CCMC)
Manhasset, New York, 11030, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Carolinas Medical Center - Charlotte
Charlotte, North Carolina, 28203, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Nationwide Children Hospital
Columbus, Ohio, 43205-2664, United States
McGee Women's Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Kimberlin, MD
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
David W Kimberlin, MD
University of Alabama at Birmingham
- PRINCIPAL INVESTIGATOR
Richard Whitley, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 14, 2013
Study Start
January 1, 2014
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
September 9, 2020
Results First Posted
September 9, 2020
Record last verified: 2020-08