CMV Refractory and Resistant Infection in Solid Organ Transplant Recipients in Argentina

NCT07787767 | Not Yet Recruiting DMC

• 1 other identifier: 7752
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will describe the frequency and characteristics of refractory and resistant cytomegalovirus (CMV) infection in adults who received a solid organ transplant in Argentina between 2017 and 2024. Researchers will review medical records from transplant centers across the country to identify episodes of CMV infection that did not respond adequately to standard antiviral treatment (refractory) or that showed genetic mutations associated with drug resistance. The study will describe the clinical features, treatments used, and outcomes (including graft function and survival) of patients with these episodes, in order to better understand how common this problem is and what factors are associated with it in the local population.

Conditions

Cytomegalovirus Infections; Solid Organ Transplantation Recipient; Solid Organ Transplantation

Keywords

CMV; refractory infection; antiviral resistance; solid organ transplant; Drug Resistance, Viral

Outcome Measures

Primary Outcomes (1)

• Incidence of refractory or resistant CMV infection

  Proportion of solid organ transplant recipients with CMV infection who meet operational criteria for refractory infection (viral load unchanged or increased after 2 weeks of appropriate antiviral treatment) or resistant infection (refractory infection plus documented genetic mutation, e.g. UL97 and/or UL54, associated with antiviral resistance)

  Within 18 months post-transplant, assessed retrospectively for the period January 2017 to December 2024

Secondary Outcomes (8)

• Incidence of overall CMV infection

  Within 18 months post-transplant, 2017-2024

• Distribution of clinical forms of CMV infection

  Within 18 months post-transplant, 2017-2024

• Frequency of antiviral resistance mutations

  From T3 (declaration of refractoriness) to T4 (episode resolution), up to 12 months

• Antiviral treatment lines and combination therapy use

  From T2 (treatment initiation) to T4 (negativization) or last available PCR if not resolved, up to 12 months

• All-cause mortality

  90 days and 1 year post-episode onset

Study Arms (1)

CMV-infected SOT recipients

Adult solid organ transplant recipients (kidney, liver, heart, lung, pancreas, or combined transplants) who developed CMV infection within 18 months post-transplant between 2017 and 2024, followed to identify episodes meeting criteria for refractory or resistant infection

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

Adult patients (≥18 years) who received a solid organ transplant (kidney, liver, heart, lung, pancreas, or combined transplant) at one of the participating centers in Argentina, and who developed cytomegalovirus (CMV) infection within 18 months following transplantation, during the period from January 1, 2017 to December 31, 2024. Cases are identified retrospectively from the transplant databases and medical records of each participating center.

You may qualify if:

• Adult patients (≥18 years) who received a solid organ transplant (kidney, liver, heart, lung, pancreas, or combined) at a participating center in Argentina between January 1, 2017 and December 31, 2024
• Documented CMV infection within 18 months post-transplant
• Followed for at least 18 months from transplant and at least 12 months from CMV infection onset

You may not qualify if:

• Patients with incomplete medical records precluding assessment of CMV infection status or key study variables
• Patients not meeting the minimum follow-up period from transplant or from infection onset

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., 1199, Argentina

Location

Related Publications (9)

• Navarro D, Fernandez-Ruiz M, Aguado JM, Sandonis V, Perez-Romero P. Going beyond serology for stratifying the risk of CMV infection in transplant recipients. Rev Med Virol. 2019 Jan;29(1):e2017. doi: 10.1002/rmv.2017. Epub 2018 Oct 25.

  PMID: 30358016 BACKGROUND

• Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P; Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.

  PMID: 30137245 BACKGROUND

• Mehta Steinke SA, Alfares M, Valsamakis A, Shoham S, Arav-Boger R, Lees L, Ostrander D, Forman MS, Shedeck A, Ambinder RF, Jones RJ, Avery RK. Outcomes of transplant recipients treated with cidofovir for resistant or refractory cytomegalovirus infection. Transpl Infect Dis. 2021 Jun;23(3):e13521. doi: 10.1111/tid.13521. Epub 2020 Dec 2.

  PMID: 33220125 BACKGROUND

• Tamzali Y, Pourcher V, Azoyan L, Ouali N, Barrou B, Conti F, Coutance G, Gay F, Tourret J, Boutolleau D. Factors Associated With Genotypic Resistance and Outcome Among Solid Organ Transplant Recipients With Refractory Cytomegalovirus Infection. Transpl Int. 2023 Jun 15;36:11295. doi: 10.3389/ti.2023.11295. eCollection 2023.

  PMID: 37398559 BACKGROUND

• Aguado JM, Navarro D, Montoto C, Yebenes M, de Castro-Oros I. Incidence of refractory CMV infection with or without antiviral resistance in Spain: A systematic literature review. Transplant Rev (Orlando). 2024 Jan;38(1):100804. doi: 10.1016/j.trre.2023.100804. Epub 2023 Nov 6.

  PMID: 37949797 BACKGROUND

• Fisher CE, Knudsen JL, Lease ED, Jerome KR, Rakita RM, Boeckh M, Limaye AP. Risk Factors and Outcomes of Ganciclovir-Resistant Cytomegalovirus Infection in Solid Organ Transplant Recipients. Clin Infect Dis. 2017 Jul 1;65(1):57-63. doi: 10.1093/cid/cix259.

  PMID: 28369203 BACKGROUND

• Kotton CN, Kumar D, Manuel O, Chou S, Hayden RT, Danziger-Isakov L, Asberg A, Tedesco-Silva H, Humar A; Transplantation Society International CMV Consensus Group. The Fourth International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2025 Jul 1;109(7):1066-1110. doi: 10.1097/TP.0000000000005374. Epub 2025 Apr 9. No abstract available.

  PMID: 40200403 BACKGROUND

• Kampouri E, Manuel O. Preemptive therapy versus universal prophylaxis: Time for reconciliation? Transpl Infect Dis. 2023 Apr;25(2):e14014. doi: 10.1111/tid.14014. Epub 2023 Feb 3. No abstract available.

  PMID: 36734636 BACKGROUND

• Stern M, Hirsch H, Cusini A, van Delden C, Manuel O, Meylan P, Boggian K, Mueller NJ, Dickenmann M; Members of Swiss Transplant Cohort Study. Cytomegalovirus serology and replication remain associated with solid organ graft rejection and graft loss in the era of prophylactic treatment. Transplantation. 2014 Nov 15;98(9):1013-8. doi: 10.1097/TP.0000000000000160.

  PMID: 24837540 BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections; Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases

Central Study Contacts

Laura Alicia Barcan, MD

CONTACT

+549 1149590200; laura.barcan@hospitalitaliano.org.ar

Emilio Felipe Huaier Arriazu, MD

CONTACT

+549 011 49590200; emilio.huaier@hospitalitaliano.org.ar

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co investigator

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)