Health Condition 1: null- Bone marrow transplant patients Health Condition 2: C948- Other specified leukemias
Conditions
Interventions
None listed
Sponsors
TRAC TMC Research Administrative Council
Eligibility
Inclusion criteria
Inclusion criteria: Patients willing to give written informed consent. Bone Marrow Transplantation patients being initiated on Colistin. Neutropenic patients whose blood culture is showing sensitive to colistin (or) Neutropenic patients not responding to Meropenem defined as hemodynamically unstable or patients with persistent fever even after 24-48 hrs of start of meropenem. ECOG PS <= 2
Exclusion criteria
Exclusion criteria: History of allergy to Colistin Patients with active HIV infection or serology positive for HBV, HCV, HAV. Any other medical condition or any abnormal lab findings which may adversely affect the patient, based on physician discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify the pharmacokinetic parameter(s) which correlate with the response to colistin in Bone marrow transplant (BMT) patientsTimepoint: Blood sample collection at the following time-points: Predose 10 min 30 min (end of infusion) 45 min 1hr 3hr 6hr 8hr Steady state On day 3 (at dose 7 or 8 or 9) Pre-dose,30 mins, Only one sample between 1-8hr | — |
Secondary
| Measure | Time frame |
|---|---|
| Develop a population pharmacokinetics (PopPK) model to individualize dosing in order to achieve PK thresholds obtained from primary objective. ï?· Develop a limited sampling strategy for ColistinTimepoint: NA | — |
Countries
India
Contacts
Public ContactK Manjunath Nookala
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed