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Genotyping of Cytomegalovirus From Patients in Israel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00228202
First received: September 26, 2005
Last updated: August 17, 2006
Last verified: January 2006
  Purpose

The researchers select 100 cytomegalovirus (CMV) DNA samples from patients diagnosed with CMV infection. Patients include bone marrow transplant patients, pregnant women and newborns. The researchers determine viral load by real-time polymerase chain reaction (PCR). They amplify CMV-gB sequences by PCR and type by sequencing and restriction fragment length polymorphism (RFLP). The researchers obtain clinical data from patients' records. They examine association between patients' clinical status and CMV-gB genotype and viral load.


Condition
Cytomegalovirus Infections

Study Type: Observational
Study Design: Observational Model: Natural History
Time Perspective: Cross-Sectional
Official Title: Cytomegalovirus Glycoprotein B Genotypes in Israeli Patients: Relationship Between CMV Genotype, Clinical and Demographic Factors

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 100
Study Start Date: September 2005
Detailed Description:

The study aims at finding association between CMV viral load and viral glycoprotein B genotype and the clinical status of patients suffering from CMV infection. Bone marrow transplant patients are at increased risk of developing severe CMV disease and are routinely followed for viral load. Fetuses are also at high risk for developing severe malformations and neurological defects following maternal primary infection during pregnancy. Therefore amniotic fluid from women diagnosed with CMV infection is examined for CMV presence. Newborns having congenital defects are tested for CMV excretion.

There is not yet any confirmed marker for assessment of the potential severity of the viral infection and for prognosis. Therefore we shall attempt to find association between the viral load and genotype and the clinical status.

CMV DNA samples prepared at the Central Virology Laboratory from clinical specimens obtained from patients for diagnostic purposes will be coded and then subjected to viral load analysis using real-time PCR. The gB genotype will be determined by either of two methods described in the literature: (a) PCR and RFLP (b) PCR and sequencing.

Relevant clinical data will be retrieved from the patients clinical records and saved as coded information to match the samples. Bone marrow transplant patients will be followed for prolonged periods covering repeated viral reactivation events. Clinical records from mothers and newborns will be matched when present. Otherwise maternal and newborn samples will be kept as is.

Statistical analysis will be performed to try and find association between the clinical status of patients, the viral load and the viral genotype.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CMV DNA sample from a transplant patient with CMV disease.
  • CMV DNA from amniotic fluid of women with CMV infection
  • CMV DNA from urine of newborns with congenital defects compatible with CMV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228202

Contacts
Contact: Ella Mendelson, PhD 972-3-530-2421 ellamen@sheba.health.gov.il
Contact: Naty Keller, MD/PhD 972-3-530-2304 kelern@sheba.health.gov.il

Locations
Israel
Central Virology Laboratory, Chaim Sheba Medical Center Tel-Hashomer Recruiting
Ramat Gan, Israel, 52621
Contact: Ella Mendelson, PhD    972-3-530-2421    ellamen@sheba.health.gov.il   
Contact: Zehava Grossman, PhD    972-3-530-2458    zehava.grossman@sheba.health.gov.il   
Principal Investigator: Ella Mendelson, PhD         
Sub-Investigator: Musa Hindiyeh, PhD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Naty Keller, MD/PhD Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00228202     History of Changes
Other Study ID Numbers: SHEBA-05-3867-NK-CTIL, Sara Orzi MSc thesis
Study First Received: September 26, 2005
Last Updated: August 17, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
cytomegalovirus
CMV
pregnancy
amniotic fluid
bone marrow
transplantation
viral load
glycoprotein B
genotyping
PCR
real-time PCR
CMV disease
Congenital CMV infection

Additional relevant MeSH terms:
Cytomegalovirus Infections
Infection
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014