Clinical trial NCT00846352: Early Versus Late Bronchoscopy in Bone Marrow Transplantation (BMT) Patients
Official title: Randomized Trial Comparing Early Versus Late Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Transplantation
Keywords: Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
Bronchoscopy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: University of Mississippi Medical Center
First posted: 2009-02-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the outcomes of bronchoscopy in Bome Marrow Transplant (BMT) patients who develop lung infiltrates suspicious for infections of the lungs. It will consist of two groups, one group will receive bronchoscopy within thirty six hours of enrollment, while the other group will receive bronchoscopy five days after enrollment. The purpose of this study is to determine the ideal time for bronchoscopy in this group of patients.

Detailed description: At this time there exist no studies that help Pulmonologists and Oncologists decide on the best time to perform diagnostic bronchoscopies in Bone Marrow Transplant patients with suspected pulmonary infections. Practice patterns vary from institution to institution and also vary widely within an institution based on the practice preferences of the attending physicians. This study is a prospective randomized trial comparing early ( within 24-36 hours of enrollment) to late ( day 5-6 after enrollment) bronchoscopy in Bone Marrow Transplant patients who develop pulmonary infiltrates or clinical evidence of respiratory infection. If patients in the late arm require earlier bronchoscopy or do not require bronchoscopy on day 5-6 then the care will be dictated by the attending physician. Only bronchoscopies that are clinically indicated will be performed.

The aim is to determine the optimal timing for performing bronchoscopy in this group of patients. The primary outcomes will be change of therapy as determined by addition or removal of antibiotics, antifungals, antivirals or steroids etc. as well as the oncologist's opinion on the impact the bronchoscopic results had on care of the patient. Patients will be followed throughout their hospitalization as well as receive a phone call 3 months after hospital discharge. Written consent will be obtained from the patients or health care power of attorney in relevant cases.

It is our hope that the results of this study will help better define the role of bronchoscopy in the management of Bone Marrow Transplant patients.

Eligibility criteria: Inclusion Criteria:

* All patients who have had allogenic or autologous HSCT who are admitted to the BMT, and felt to need bronchoscopy by their physician.

Exclusion Criteria:

* Active hemoptysis, allergies to topical and IV anesthetics with no appropriate substitutes available. Being on non-invasive positive pressure ventilation that would not allow for safe bronchoscopy.

Primary outcomes:
measure: Change in therapy due to results obtained from bronchoscopy.
timeFrame: When results of bronchoscopy are available
Secondary outcomes:
measure: In-Hospital and three month mortality
timeFrame: Three months from time of enrollment
measure: Duration of antibiotic therapy
timeFrame: Variable
Other outcomes:
Locations:
city: Jackson
country: United States
facility: The University of Mississippi Medical Center
state: Mississippi
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Wake Forest University Health Sciences
name: John F Conforti, D.O
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kantrow SP, Hackman RC, Boeckh M, Myerson D, Crawford SW. Idiopathic pneumonia syndrome: changing spectrum of lung injury after marrow transplantation. Transplantation. 1997 Apr 27;63(8):1079-86. doi: 10.1097/00007890-199704270-00006.
citation: Krowka MJ, Rosenow EC 3rd, Hoagland HC. Pulmonary complications of bone marrow transplantation. Chest. 1985 Feb;87(2):237-46. doi: 10.1378/chest.87.2.237.
citation: Seiden MV, Elias A, Ayash L, Hunt M, Eder JP, Schnipper LE, Frei E 3rd, Antman KH. Pulmonary toxicity associated with high dose chemotherapy in the treatment of solid tumors with autologous marrow transplant: an analysis of four chemotherapy regimens. Bone Marrow Transplant. 1992 Jul;10(1):57-63.
citation: Rano A, Agusti C, Jimenez P, Angrill J, Benito N, Danes C, Gonzalez J, Rovira M, Pumarola T, Moreno A, Torres A. Pulmonary infiltrates in non-HIV immunocompromised patients: a diagnostic approach using non-invasive and bronchoscopic procedures. Thorax. 2001 May;56(5):379-87. doi: 10.1136/thorax.56.5.379.
citation: White P, Bonacum JT, Miller CB. Utility of fiberoptic bronchoscopy in bone marrow transplant patients. Bone Marrow Transplant. 1997 Oct;20(8):681-7. doi: 10.1038/sj.bmt.1700957.