NCT03910478

Dried Blood Spot Testing of CMV Detection in HCT Recipients

Completed NA Results posted Last updated 25 February 2026

What this trial tests

NA trial testing DBS Self-Collection Kit in Cytomegalovirus Infection in 622 participants. Completed in 16 January 2024.

Timeline

3 May 2019

Primary endpoint
16 January 2024

16 January 2024

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	622
Start date	3 May 2019
Primary completion	16 January 2024
Estimated completion	16 January 2024
Sites	4 locations across United States

Drugs / interventions tested

• DBS Self-Collection Kit
• Standard Control Strategy

Conditions studied

• Cytomegalovirus Infection — all drugs for Cytomegalovirus Infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 15 to 99, any sex, with Cytomegalovirus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the ITT Population Primary · At one year after Hematopoietic cell transplantation (HCT)

To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed \>90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	27
Standard Monitoring Control	15

The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the mITT Population Primary · At one year after Hematopoietic cell transplantation (HCT)

To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed \>90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	22
Standard Monitoring Control	20

The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the ITT Population Secondary · By 1 year after Hematopoietic cell transplantation (HCT)

The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	6	0 – 45
Standard Monitoring Control	11	0 – 55

The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the mITT Population Secondary · By 1 year after Hematopoietic cell transplantation (HCT)

The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	11	0 – 45
Standard Monitoring Control	11	0 – 55

Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable Secondary · By 1 year after Hematopoietic cell transplantation (HCT)

Proven or probable CMV disease is a serious adverse event of special interest. The number of participants experiencing proven or probable CMV disease between Hematopoietic cell transplantation (HCT) and 365 days after HCT.

Possible

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	0
Standard Monitoring Control	0

Probable

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	0
Standard Monitoring Control	0

Proven

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	2
Standard Monitoring Control	2

Probable/Proven

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	2
Standard Monitoring Control	2

Number of Participants With Finger-stick Procedure-related Grade 3 Adverse Events (AEs) in the DBS Arm Secondary · By 1 year after Hematopoietic cell transplantation (HCT)

To evaluate the safety of DBS monitoring, Finger-stick procedure-related Grade 3 AEs were abstracted through medical chart review at quarterly contacts and at the final close-out contact. Participants were considered as meeting the outcome measure if they had at least one finger-stick procedure-related Grade 3 AE during the study period.

Group	Value	95% CI
Self-collected Dried Blood Spot (DBS) Monitoring	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Self-collected Dried Blood Spot (DBS) Monitoring

Serious: 2/94 (2%)

Deaths: 16/113

Standard Monitoring Control

Serious: 2/58 (3%)

Deaths: 7/59

Serious adverse events (5 terms)

Reaction	System	Self-collected Dried Blood…	Standard Monitoring Control
Cytomegalovirus gastroenteritis	Infections and infestations	—	—
Pneumonia cytomegaloviral	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Cytomegalovirus duodenitis	Infections and infestations	—	—
Cytomegalovirus colitis	Infections and infestations	—	—

Most-reported serious reactions: Cytomegalovirus gastroenteritis, Pneumonia cytomegaloviral, Pneumonia, Cytomegalovirus duodenitis, Cytomegalovirus colitis.

Data from ClinicalTrials.gov NCT03910478 adverse events section.

Sponsor's own description

This is a randomized clinical trial to assess whether a subject centered, self-collection of Dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients \> /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cytomegalovirus Infection in Solid Organ and Hematopoietic Cell Transplantation: State of the Evidence.
   Haidar G, Boeckh M, Singh N. · · 2020 · cited 94× · PMID 32134486 · DOI 10.1093/infdis/jiz454
2. Progress and Challenges in the Prevention, Diagnosis, and Management of Cytomegalovirus Infection in Transplantation.
   Limaye AP, Babu TM, Boeckh M. · · 2020 · cited 87× · PMID 33115722 · DOI 10.1128/cmr.00043-19
3. Laboratory diagnostic testing for cytomegalovirus infection in solid organ transplant patients.
   Lee H, Oh EJ. · · 2022 · cited 11× · PMID 35769434 · DOI 10.4285/kjt.22.0001