Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia
Status: | Completed |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/1/2016 |
Start Date: | March 2015 |
End Date: | June 2016 |
Assessment of the Safety and Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia in Patients With Hematologic Malignancies and Stem Cell Transplant Recipients.
The main objective of this study is to assess the safety of administering intravenous (IV)
pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with
hematologic malignancies and stem cell transplant recipients. There will also be an
assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic
therapy.
pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with
hematologic malignancies and stem cell transplant recipients. There will also be an
assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic
therapy.
This study is a prospective, single arm study to assess safety of IV pentamidine for PJP
prophylaxis. Patient satisfaction associated with IV pentamidine will also be assessed using
a survey adapted from the validated Treatment Satisfaction Questionnaire for Medication
(version 1.4).
Adult patients with a hematologic malignancy or who are receiving or have received a
stem-cell transplant at the University of Illinois Hospitals and Clinics who have an
indication for PJP prophylaxis therapy. They will receive intravenous pentamidine during
their planned admissions for chemotherapy when they have an indication for and/or are due to
receive pentamidine prophylaxis. These patients are outlined below in the inclusion
criteria. Patients may or may not have received aerosolized or IV pentamidine prior to
inclusion in the study.
Eligible patients will receive IV pentamidine during hospital admissions. Patients will be
routinely monitored by nursing staff during and after the infusion. Nursing staff will
monitor the systolic and diastolic blood pressure at baseline and one hour post infusion.
Patients will also be monitored for nausea/vomiting. Patients who receive IV pentamidine
will have anti-emetics available on call to use in the event that they become nauseous. Data
will be collected on the type, grade, and incidence of adverse effects by research
personnel.
prophylaxis. Patient satisfaction associated with IV pentamidine will also be assessed using
a survey adapted from the validated Treatment Satisfaction Questionnaire for Medication
(version 1.4).
Adult patients with a hematologic malignancy or who are receiving or have received a
stem-cell transplant at the University of Illinois Hospitals and Clinics who have an
indication for PJP prophylaxis therapy. They will receive intravenous pentamidine during
their planned admissions for chemotherapy when they have an indication for and/or are due to
receive pentamidine prophylaxis. These patients are outlined below in the inclusion
criteria. Patients may or may not have received aerosolized or IV pentamidine prior to
inclusion in the study.
Eligible patients will receive IV pentamidine during hospital admissions. Patients will be
routinely monitored by nursing staff during and after the infusion. Nursing staff will
monitor the systolic and diastolic blood pressure at baseline and one hour post infusion.
Patients will also be monitored for nausea/vomiting. Patients who receive IV pentamidine
will have anti-emetics available on call to use in the event that they become nauseous. Data
will be collected on the type, grade, and incidence of adverse effects by research
personnel.
Inclusion Criteria:
- Adults (18 years or older)
- Hematologic malignancy diagnosis or stem-cell transplant recipient
- Eligible for PJP prophylaxis therapy at time of enrollment as per institutional
guidelines in compliance with NCCN guidelines. These patients include:
- Acute myeloid leukemia patients receiving induction and consolidation (first line and
relapsed/refractory)
- Acute lymphoid leukemia patients receiving HyperCVAD/R (cyclophosphamide,
vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, rituximab)
- Lymphoma patients receiving ICE (ifosfamide, carboplatin, etoposide), DA-R-EPOCH
(dose-adjusted rituximab, etoposide, prednisone, vincristine, cyclophosphamide,
doxorubicin), and other inpatient lymphoma regimens
- Patients receiving other inpatient chemotherapy regimens that are given on a monthly
basis
- Patients who have received an allogeneic stem cell transplant
- Have given informed consent
- May have previously received inhaled or IV pentamidine
Exclusion Criteria:
- Pregnancy
- Prisoners
- Patients with a documented allergy or hypersensitivity to pentamidine.
We found this trial at
1
site
Chicago, Illinois 60612
Phone: 312-996-1366
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