Ganciclovir Resistant Cytomegalovirus Infection in SOT Recipients.

NCT05234723 | Unknown

• 1 other identifier: ReCySOT
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

ReCySOT study is a multicenter, retrospective, observational case-control study on risk factors for developing a ganciclovir-resistant (GCV-R) cytomegalovirus infection in patients receiving solid organ transplant. Aims of the study are to investigate the incidence of and risk factors for GCV-R CMV infection in SOT recipients in order to design further studies aimed at preventing and improving the patient management of GCV-R CMV infections.

Conditions

Cytomegalovirus Infections

Keywords

Ganciclovir-resistant CMV; Cytomegalovirus; Solid Organ Transplant; Ganciclovir

Outcome Measures

Primary Outcomes (2)

• To define incidence of GCV-R CMV-infection in SOT patients

  To define incidence of GCV-R CMV-infection in SOT patients

  Through study completion, an average of 1 year

• To define the risk factors for GCV-R CMV-infection development in SOT patients

  To define the risk factors for GCV-R CMV-infection development in SOT patients

  Through study completion, an average of 1 year

Secondary Outcomes (9)

• To compare type of CMV episode between SOT patients with GCV-R versus GCV-S CMV-infection.

  Through study completion, an average of 1 year

• To compare virological cure between SOT patients with GCV-R versus GCV-S CMV-infection.

  Through study completion, an average of 1 year

• To compare clinical cure between SOT patients with GCV-R versus GCV-S CMV-infection.

  Through study completion, an average of 1 year

• To compare graft outcome between SOT patients with GCV-R versus GCV-S CMV-infection.

  Through study completion, an average of 1 year

• To compare the need of ICU and hospital stay between SOT patients with GCV-R versus GCV-S CMV-infection.

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult (≥ 18 years) patients who underwent SOT developing CMV-infection during the study period will be screened for inclusion according to inclusion and exclusion criteria. Eligible patients will be classified as cases or controls according to the following definitions: * Case: SOT recipients with genotypically confirmed GCV-R CMV-event; * Control: SOT recipients with "presumed" GCV-S CMV-event on the basis of good microbiological and clinical response to standard GCV/VGC treatment.

You may qualify if:

• Diagnosis of CMV infection in adult (age ≥ 18 years) patients underwent SOT
• Ability to understand the purpose of the study and provide signed and dated informed consent

You may not qualify if:

• Lack of clinical and/or laboratory data to establish the type of CMV event
• Lack of the serological mismatch at transplantation
• Lack of the type of SOT
• Lack of the patient and graft outcome at 30, 60 or 90 days after CMV event diagnosis.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

MeSH Terms

Conditions

Cytomegalovirus Infections; Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases

Central Study Contacts

Renato Pascale, MD

CONTACT

+390512143199; renato.pascale@aosp.bo.it

Maddalena Giannella, MD, PHD

CONTACT

+390512143199; maddalena.giannella@unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 10, 2022
• Study Start: February 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02