Health Condition 1: null- Patients undergoing bone marrow transplantation and identification of cutoffs for initiation of ganciclovir therapy in patients who show reactivation of CMV infection
Conditions
Interventions
Intervention1: Ganciclovir: Initiation of
preemptive therapy with
ganciclovir when CMV DNA
levels show a value of 1000
copies/ml and above (Group 1)
Sponsors
INVESTIGATOR INITIATED
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients who are initiated on pre-emptive therapy with ganciclovir using DNAemia cutoff of 1000 copies/ml whole blood vs. more than 0.5 log rise above 1000 copies/ml in bone marrow transplant recipientsTimepoint: Every 12 weeks for 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the kinetics of CMV DNA levels in BMT patients who reactivate CMV within the first 12 weeks post transplant (by serial monitoring with real time PCR) 2. To standardize CMV IE-mRNA reverse transcriptase PCR and determine the limit of detection of CMV IE-mRNA levels by RT-PCRTimepoint: FIRST 12 WEEKS POST TRANSPLANT | — |
Countries
India
Contacts
Public ContactDR BIJU GEORGE
CMC, VELLORE
Outcome results
None listed