Cytomegalovirus (CMV) in solid organ transplant patients
| ISRCTN | ISRCTN10633953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10633953 |
| IRAS number | 287134 |
| Secondary identifying numbers | TAK620-5001, IRAS 287134, CPMS 46421 |
- Submission date
- 29/09/2021
- Registration date
- 25/11/2021
- Last edited
- 24/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Cytomegalovirus (CMV) is closely related to the viruses that cause chickenpox and mononucleosis (mono). CMV infections are very common, and most of us will probably have one in our lifetimes.
CMV is one of the most common infections that affect people with a solid organ transplant (SOT). The goal of this study is to describe the treatment patterns and outcomes of CMV in about 400 SOT recipients globally who required treatment for the management of CMV.
Who can participate?
Records from patients that were over 18 years old at the time of the SOT and subsequently were diagnosed with a CMV infection.
What does the study involve?
The study will use the healthcare information that has already been documented from January 1, 2014 (until no later than determined at site level) related to the SOT, CMV infections and outcomes including: hospital visits, clinic visits, written follow-up notes, drug treatments, tests, and procedures. This observational study uses records from routine healthcare. Thus, the results of the study are not expected to be directly or immediately relevant to patient care and will not be shared with each research participant.
What are the possible benefits and risks of participating?
This is a retrospective observational type of study so there are no physical risks that will result from taking part in this study. Taking part in this study has the very low risk of personally identifying information (PII) being accessed by unauthorized people (i.e., individuals who are not part of the study team). To reduce the risk of sharing PII with unauthorized persons, patient identifiers will be removed before being used in research so as to maintain confidentiality and privacy protection. None of the research data will enable identification of individual patients. It is expected there will be limited or no direct or immediate benefit to participants.
Where is the study run from?
Shire Human Genetic Therapies, Inc. a wholly-owned subsidiary of Takeda Pharmaceutical Company Ltd (USA)
When is the study starting and how long is it expected to run for?
May 2019 to December 2021
Who is funding the study?
Shire Human Genetic Therapies, Inc. a wholly-owned subsidiary of Takeda Pharmaceutical Company Ltd (USA)
Who is the main contact?
Ishan Hirji, Ishan.hirji@takeda.com
Contact information
Public
650 E. Kendall Street
Cambridge, MA
02142
United States of America
| Phone | +1 6175888190 |
|---|---|
| ishan.hirji@takeda.com |
Scientific
650 E. Kendall Street
Cambridge, MA
02142
United States of America
| Phone | +1 6175888190 |
|---|---|
| ishan.hirji@takeda.com |
Study information
| Study design | Multinational non-interventional retrospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Retrospective |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Multinational CMV Outcomes, Treatment Patterns and Healthcare Resource Utilization Study (OTUS) Following Solid Organ Transplant (SOT) |
| Study acronym | OTUS SOT |
| Study objectives | Primary: Evaluate and describe the clinical outcomes with current management patterns. Secondary: (1) Describe the treatment patterns of CMV management. (2) Describe the patient / clinical characteristics of transplant patients. (3) Describe the economic burden and healthcare resource utilization of CMV. |
| Ethics approval(s) | Approved 06/10/2020, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8085; bradfordleeds.rec@hra.nhs.uk), ref: 20/YH/0288 |
| Health condition(s) or problem(s) studied | Cytomegalovirus infection in transplanted patients |
| Intervention | The study will use the healthcare information that has already been documented from January 1, 2014 (until no later than determined at site level) related to the SOT, CMV infections and outcomes including: hospital visits, clinic visits, written follow-up notes, drug treatments, tests, and procedures. This observational study uses records from routine healthcare. |
| Intervention type | Other |
| Primary outcome measure | Patient outcomes measured using patient records: 1. Number of CMV viremia episodes 2. Time to CMV viremia clearance and control 3. Incidence and time to CMV recurrence 4. Incidence of tissue invasive disease, CMV syndrome, graft rejection, graft loss, anti-CMV treatment-related myelosuppression, nephrotoxicity, or CMV resistance 5. Overall survival |
| Secondary outcome measures | Patient outcomes measured using patient records: 1. Frequency of first-, second-and third-line anti-CMV therapies, duration of therapy and time to second-line (or third-line) therapy; time to incident CMV infection and treatment initiation, viral load at time of treatment initiation or switch; medication utilization. 2. Patient pre-transplant characteristics: demographics, transplant indication, viral coinfections, significant comorbidities, underlying immunodeficiencies; Clinical / transplant characteristics; Risk factors for resistant/refractory/intolerant CMV 3. Inpatient/outpatient healthcare utilization; length of hospital stay; diagnostic tests; CMV resistance testing; anti-CMV toxicity management. |
| Overall study start date | 20/05/2019 |
| Completion date | 21/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 218 |
| Key inclusion criteria | 1. Aged ≥18 years at the time of the SOT 2. Received a SOT after January 1, 2014 3. Diagnosed with CMV infection any time after the SOT date 4. Required ≥1 anti-CMV agent to manage CMV infection and were (a) resistant to currently available treatments OR (b) refractory to currently available treatments OR (c) considered intolerant to currently available treatments 5. Follow-up data are available for at least 12 months (1 year) after being characterized in item #4 (above) or until death, whichever occurs first |
| Key exclusion criteria | Positive test for HIV before the SOT |
| Date of first enrolment | 23/10/2020 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- England
- France
- Germany
- Spain
- United Kingdom
- United States of America
Study participating centres
SE1 7EH
United Kingdom
Spain
France
France
Germany
Spain
United States of America
United States of America
United States of America
United States of America
United States of America
Germany
Germany
Germany
Sponsor information
Industry
Takeda Development Centers
95 Hayden Avenue
Lexington, MA
02421
United States of America
| Phone | +1-617-953-7484 |
|---|---|
| polina.ioffe@takeda.com | |
| Website | https://www.takeda.com |
"ROR" |
https://ror.org/03bygaq51 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Takeda, Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals America, Inc., Takeda in the U.S., TPUSA
- Location
- United States of America
Results and Publications
| Intention to publish date | 28/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study are intended to be disseminated through publication in peer reviewed scientific journals and other publications (i.e. internal reports). |
| IPD sharing plan | The datasets generated and/or analysed during the study will be made available upon request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymization. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | Text-based summary of results | 30/07/2023 | 24/08/2023 | No | No |
Additional files
- ISRCTN10633953_Other unpublished results_30Jul2023.pdf
- Text-based summary of results
Editorial Notes
24/08/2023: A text-based summary of results has been added.
25/01/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/12/2021 to 21/12/2021.
2. The total final enrolment was added.
07/12/2021: Internal review.
27/10/2021: Trial's existence confirmed by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee.
