Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia

NCT02669706 | Completed

• 1 other identifier: 2014-1000
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of confirmed cases of PJP diagnosed

  1 year

Study Arms (1)

IV pentamidine

Pentamidine 4mg/kg IV every month (maximum 300mg)

Drug: Pentamidine

Interventions

Pentamidine DRUG

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

Also known as: NebuPent, Pentam

IV pentamidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of adult patients with hematologic malignancies and/or hematopoietic stem cell transplant recipients who have an indication for PJP prophylaxis with pentamidine. Further details are outlined in the inclusion/exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Prisoners
• Patients with a documented allergy or hypersensitivity to pentamidine.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, 60612, United States

Location

Related Publications (7)

• 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.

  PMID: 22491773 BACKGROUND

• 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. doi: 10.4065/82.9.1052.

  PMID: 17803871 BACKGROUND

• 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.

  PMID: 24030353 BACKGROUND

• 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. No abstract available.

  PMID: 1307553 BACKGROUND

• 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.

  PMID: 23538522 BACKGROUND

• 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. doi: 10.1002/pbc.21287.

  PMID: 17635000 BACKGROUND

• Sweiss K, Anderson J, Wirth S, Oh A, Quigley JG, Khan I, Saraf S, Mactal-Haaf C, Rondelli D, Patel P. A prospective study of intravenous pentamidine for PJP prophylaxis in adult patients undergoing intensive chemotherapy or hematopoietic stem cell transplant. Bone Marrow Transplant. 2018 Mar;53(3):300-306. doi: 10.1038/s41409-017-0024-1. Epub 2017 Dec 21.

  PMID: 29269796 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals

Study Officials

• Jennifer Anderson, PharmD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 1, 2016
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 30, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)