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OpenTrials
Completed

NCT Number: NCT00566072

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

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.

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Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

instructions and coaching

Behavioral

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

Primary outcomes

  1. relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation

    Time frame: weekly follow-up

Secondary outcomes

  1. relation between compliance and the instructions which a patient gets about intake of medication

    Time frame: weekly follow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Important dates

Study start
2001
Study completion
2003
First posted
Dec 3, 2007
Registry last updated
Dec 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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