Clinical trial · Observational
Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia
Assessment of the Safety and Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia in Patients With Hematologic Malignancies and Stem Cell Transplant Recipients.
NCT02669706CI-TRIAL-00022795completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pentamidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- IV pentamidine
- description
- Pentamidine 4mg/kg IV every month (maximum 300mg)
- interventionNames
- Drug: Pentamidine
Primary outcomes (1)
- measure
- Safety of IV pentamidine for PJP prophylaxis
- timeFrame
- 1 year
- description
- Safety will be assessed via analyzing the number of patients experiencing adverse effects, with their severity graded using CTCAE v4.0.
Secondary outcomes (1)
- measure
- Number of confirmed cases of PJP diagnosed
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDMorris 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
- BACKGROUNDGreen 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
- BACKGROUNDOrgel 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
- BACKGROUNDSahoo 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
- BACKGROUNDDeMasi 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
- BACKGROUNDKim 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
- DERIVEDSweiss 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.