CYTOCOR
Trial question
Is immunoguided prophylaxis noninferior to standard care in preventing CMV disease in low-risk lung transplant recipients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 150
150 patients (48 female, 102 male).
Inclusion criteria: adult lung transplant recipients.
Key exclusion criteria: CMV seronegativity; HIV infection; pregnancy or lactation; multivisceral transplant recipients.
Interventions
N=75 immunoguided prophylaxis (3 months of universal prophylaxis followed by CMV-specific cell-mediated immunity-guided discontinuation for a total of 12 months).
N=75 standard prophylaxis (recommended prophylaxis with valganciclovir for 6 months followed by pre-emptive therapy for a total of 12 months).
Primary outcome
Cytomegalovirus disease at 18 months
18.7%
16%
18.7 %
14.0 %
9.3 %
4.7 %
0.0 %
Immunoguided
prophylaxis
Standard
prophylaxis
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in CMV disease at 18 months (18.7% vs. 16%; RD -0.03, 95% CI -0.15 to 0.06).
Secondary outcomes
Significant decrease in asymptomatic CMV replication (4% vs. 16%; RD 0.12, 95% CI 0.03 to 0.21).
No significant difference in CMV viral syndrome (17.3% vs. 10.7%; AD 6.6%, 95% CI -4.13 to 17.33).
No significant difference in CMV organ disease (1.3% vs. 5.3%; AD -4%, 95% CI -9.97 to 1.97).
Safety outcomes
No significant differences in neutropenia, transplant rejection.
Significant differences in number of days of antiviral prophylaxis (137 days vs. 198 days), > 180 days of antiviral prevention using valganciclovir (40% vs. 62.7%).
Conclusion
In adult lung transplant recipients, immunoguided prophylaxis was noninferior to standard prophylaxis with respect to CMV disease at 18 months.
Reference
Aurora Páez-Vega, José M. Vaquero-Barrios, Elisa Ruiz-Arabi et al. Safety and efficacy of immunoguided prophylaxis for cytomegalovirus disease in low-risk lung transplant recipients in Spain: a multicentre, open-label, randomised, phase 3, noninferiority trial. Lancet Reg Health Eur. 2025 May:52:101268.
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