Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of the Safety and Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia in Patients With Hematologic Malignancies and Stem Cell Transplant Recipients.

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Drug: Pentamidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IV pentamidine<br>Pentamidine 4mg/kg IV every month (maximum 300mg) | Drug: Pentamidine<br>* Pentamidine is an antimicrobial medication given for prevention and treatment of Pneumocystis pneumonia (PJP) caused by Pneumocystis jirovecii<br>* Other names: Pentam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of IV pentamidine for PJP prophylaxis | Safety will be assessed via analyzing the number of patients experiencing adverse effects, with their severity graded using CTCAE v4.0. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of confirmed cases of PJP diagnosed |  | 1 year |