Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)

NCT06341543 | Recruiting DMC

• 2 other identifiers: QUANTIFOTPHRCI-2021-68
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

Context Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients. Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy. As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France). Aim of the study The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy. Methods Participation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL. The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).

• In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.
• in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive. In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect). The participants will be sampled:
• 5 to 12 days after QF-CMV sampling (V2) ;
• 7 to 14 days days after V2 (V3 - between D12 and D26) ;
• 7 to 14 days days after V3 (V4 - between D19 and D40) . Endpoints The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:
• Blood CMV viral load \>10,000 IU/mL \[4 log\];
• And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise \>5000 IU/mL;
• And/or the onset of CMV disease. The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).

Conditions

Cytomegalovirus Infections; Heart Transplantation; Kidney Transplantation; Lung Transplantation; Liver Transplantation

Keywords

solid organ transplantation; cytomegalovirus; CMV; quantiferon; IGRA; interferon gamma release assay; antiviral; adverse effect; viremia

Outcome Measures

Primary Outcomes (2)

• proportion of participants with CMV viral load (>10,000 IU/mL, or increase ≥0.5 log IU/mL)

  Uncontrolled infection 5 to 12 days after QF-CMV sampling is defined as follows: * Blood CMV viral load \>10,000 IU/mL \[4 log\]; * And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise \>5000 IU/mL

  5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection

• proportion of participants with CMV disease

  CMV disease is defined as follows: * pneumonia onset * colitis onset * encephalitis onset * hepatitis onset

  5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection

Secondary Outcomes (5)

• proportion of participants with antiviral-associated anemia

  5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection

• proportion of participants with antiviral-associated leucopenia

  5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection

• proportion of participants with antiviral-associated thrombopenia

  5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection

• proportion of participants with antiviral-associated tubulotoxicity (hypokaliemia)

  5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection

• antiviral-associated kidney failure (creatininemia)

  5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection

Study Arms (2)

Qantiferon CMV result communicated to the clinician in charge

EXPERIMENTAL

In this arm, the result of the CMV-QF will be communicated to the clinician in charge. If QF-CMV is positive, the clinician will be advised not to treat the patient. If QF-CMV is negative, he/she will be advised to use or not antiviral therapy, according to the guidelines and the local practice.

Diagnostic Test: Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes).; Other: Communication of the result of the QF-CMV to the clinician in charge

Qantiferon CMV result NOT communicated to the clinician in charge

OTHER

In this arm, the result of the CMV-QF will NOT be communicated to the clinician in charge. He/she will be advised to use or not antiviral therapy, according to the guidelines and the local practice.

Diagnostic Test: Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes).

Interventions

Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes). DIAGNOSTIC_TEST

The QF-CMV will be performed in all participants.

Qantiferon CMV result NOT communicated to the clinician in charge; Qantiferon CMV result communicated to the clinician in charge

Communication of the result of the QF-CMV to the clinician in charge OTHER

The result of the CMV-QF will be communicated to the clinician in charge only for the patients randomised in the group "communication of the QF-CMV result to the clinician in charge".

Qantiferon CMV result communicated to the clinician in charge

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Solid organ transplant recipient (heart, kidney, liver and lung)
• Detectable CMV viral load between 1,000 and 15,000 IU/mL (including 2 borderline values):
• Asymptomatic (no fever or organ dysfunction) ;
• Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis;
• Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used.
• Having signed an informed consent form.
• Affiliated to a social security scheme.

You may not qualify if:

• Presence of anti-Herpesviridae treatment when CMV replication is detected (\[val\]aciclovir, \[val\]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir).
• Pregnant or breast-feeding women.
• Persons under guardianship or trusteeship.
• Subjects under administrative or judicial supervision.
• Subject unable to be contacted in case of emergency.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, Maryland, 38043, France

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections; Viremia

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Martine Pernollet

  CHU Grenoble Alpes

  STUDY CHAIR

Central Study Contacts

Olivier Epaulard, MD, PhD

CONTACT

0476765291; oepaulard@chu-grenoble.fr

Martine Pernollet, MD

CONTACT

0476766326; mpernollet@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 2, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: beginning 3 months and ending 5 years following article publication.
• Access Criteria: beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal.will be given access to these data.

Locations

FR (1)