Cytomegalo Virus infection reactivation in Bone Marrow Transplant patients with use of Ganciclovir.
Not Applicable
- Conditions
- Health Condition 1: null- Patients undergoing bone marrowtransplantation and identification of cutoffs forinitiation of ganciclovir therapy in patients whoshow reactivation of CMV infection
- Registration Number
- CTRI/2014/03/004483
- Lead Sponsor
- INVESTIGATOR INITIATED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 68
Inclusion Criteria
1. Patients undergoing allogeneic bone marrow transplant at our
centre
2. Patients who reactivate CMV within first 100 days following
allogeneic BMT
Exclusion Criteria
1. Patients who do not consent to the study
2. Patients who reactivate beyond 100 days following allogeneic
BMT
3. Patients where the initial level is 10,000 copies/ml
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the proportion of patients who are <br/ ><br>initiated on pre-emptive therapy with ganciclovir <br/ ><br>using DNAemia cutoff of 1000 copies/ml whole <br/ ><br>blood vs. more than 0.5 log rise above 1000 <br/ ><br>copies/ml in bone marrow transplant recipientsTimepoint: Every 12 weeks for 2 years.
- Secondary Outcome Measures
Name Time Method 1. To evaluate the kinetics of CMV DNA levels in <br/ ><br>BMT patients who reactivate CMV within the first <br/ ><br>12 weeks post transplant (by serial monitoring <br/ ><br>with real time PCR) <br/ ><br>2. To standardize CMV IE-mRNA reverse <br/ ><br>transcriptase PCR and determine the limit of <br/ ><br>detection of CMV IE-mRNA levels by RT-PCRTimepoint: FIRST 12 WEEKS POST TRANSPLANT