Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia
NCT ID: NCT02669706
Last Updated: 2016-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2015-03-31
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IV pentamidine
Pentamidine 4mg/kg IV every month (maximum 300mg)
Pentamidine
Pentamidine is an antimicrobial medication given for prevention and treatment of Pneumocystis pneumonia (PJP) caused by Pneumocystis jirovecii
Interventions
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Pentamidine
Pentamidine is an antimicrobial medication given for prevention and treatment of Pneumocystis pneumonia (PJP) caused by Pneumocystis jirovecii
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prisoners
* Patients with a documented allergy or hypersensitivity to pentamidine.
18 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Jennifer Anderson
PharmD
Principal Investigators
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Jennifer Anderson, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2014-1000
Identifier Type: -
Identifier Source: org_study_id