Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669706
• Other study ID #: 2014-1000
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2016
• Last updated: June 29, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematologic Malignancy
• Neoplasms
• Pneumonia, Pneumocystis

Intervention

Drug:
• Pentamidine
Pentamidine is an antimicrobial medication given for prevention and treatment of Pneumocystis pneumonia (PJP) caused by Pneumocystis jirovecii

Locations

Country	Name	City	State
United States	University of Illinois Hospital and Health Sciences System	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (6)

DeMasi JM, Cox JA, Leonard D, Koh AY, Aquino VM. Intravenous pentamidine is safe and effective as primary pneumocystis pneumonia prophylaxis in children and adolescents undergoing hematopoietic stem cell transplantation. Pediatr Infect Dis J. 2013 Sep;32(9):933-6. doi: 10.1097/INF.0b013e318292f560. — View Citation

Green H, Paul M, Vidal L, Leibovici L. Prophylaxis of Pneumocystis pneumonia in immunocompromised non-HIV-infected patients: systematic review and meta-analysis of randomized controlled trials. Mayo Clin Proc. 2007 Sep;82(9):1052-9. Review. — View Citation

Kim SY, Dabb AA, Glenn DJ, Snyder KM, Chuk MK, Loeb DM. Intravenous pentamidine is effective as second line Pneumocystis pneumonia prophylaxis in pediatric oncology patients. Pediatr Blood Cancer. 2008 Apr;50(4):779-83. — View Citation

Morris A, Norris KA. Colonization by Pneumocystis jirovecii and its role in disease. Clin Microbiol Rev. 2012 Apr;25(2):297-317. doi: 10.1128/CMR.00013-12. Review. — View Citation

Orgel E, Rushing T. Efficacy and tolerability of intravenous pentamidine isethionate for Pneumocystis jiroveci prophylaxis in a pediatric oncology population. Pediatr Infect Dis J. 2014 Mar;33(3):319-21. doi: 10.1097/INF.0000000000000044. — View Citation

Sahoo RC. Adenosine deaminase in the diagnosis of tubercular pleural effusion--how far it is helpful. J Assoc Physicians India. 1992 Nov;40(11):772. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of confirmed cases of PJP diagnosed		1 year	No