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NCT00566072 Clinical Trial

The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

Cytomegalovirus Infections Clinical Trial

Official title:
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00566072
Other study ID # 2001/181
Secondary ID
Status Completed
Phase N/A
First received November 30, 2007
Last updated December 4, 2007
Start date May 2001
Est. completion date May 2003

Study information
Verified date December 2007
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

21 patients were randomised to receive instructions and coaching or no intervention on the use and intake of ganciclovir. Intake of medication was measured by an electronic pill box. The duration of the study was 100 days.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date May 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- men and women between 18 and 65 years old

- de novo kidney transplant patients

- patients who need CMV prophylaxis with ganciclovir during 3 months

- patients who gave informed consent after an oral explanation of the study

Exclusion Criteria:

- patients who are seronegative for CMV virus and who received a kidney from a CMV negative donor

- patients with a creatinin clearance of less than 10 ml/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• instructions and coaching
instructions and coaching or no intervention on the use and intake of ganciclovir

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Hoffmann-La Roche

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation weekly follow-up No
Secondary relation between compliance and the instructions which a patient gets about intake of medication weekly follow-up No
See also
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Completed NCT02642822 - The Epidemiologic Study of Human Cytomegalovirus（CMV） in Female Students of Xiamen University N/A
Completed NCT02134184 - The Influence of Chronic CMV Infection on Influenza Vaccine Responses Phase 4
Completed NCT00673868 - Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants Phase 1
Active, not recruiting NCT05089630 - A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults Phase 1/Phase 2
Not yet recruiting NCT06058858 - Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
Active, not recruiting NCT04904614 - Letermovir Use in Heart Transplant Recipients Phase 4
Completed NCT01986010 - Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001) Phase 1

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