Clinical Trial: Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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 Summary:

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.

Sponsor: University of Illinois at Chicago

Current Primary Outcome: Safety of IV pentamidine for PJP prophylaxis [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of confirmed cases of PJP diagnosed [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: University of Illinois at Chicago

Dates:
Date Received: January 25, 2016
Date Started: March 2015
Date Completion:
Last Updated: June 29, 2016
Last Verified: June 2016