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FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328873
First Posted: April 5, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
Results First Submitted: October 5, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Infiltrate New
Intervention: Other: Microbiological analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period - May 2011 - Sept 2015 Patients were identified in either the outpatient clinic or inpatient BMT/Leukemia unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded only if they refused to participate or required antibiotic changes within the 7 days prior to being approached for the study. An additional 2 pateints were considered screen failures for this study and did not proceed.

Reporting Groups
  Description
Laboratory Testing

All patients will receive the lab testing on bronchoscopy specimens

Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens


Participant Flow:   Overall Study
    Laboratory Testing
STARTED   49 
COMPLETED   49 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Laboratory Testing

All patients will receive the lab testing on bronchoscopy specimens

Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens


Baseline Measures
   Laboratory Testing 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age [1] 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      36  73.5% 
>=65 years      13  26.5% 
[1] Patients were treated in an adult center. All patients were over the age of 18.
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18  36.7% 
Male      31  63.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3   6.1% 
Not Hispanic or Latino      46  93.9% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   4.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      8  16.3% 
White      39  79.6% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   49 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Positive Culture or Molecular Results After Brochoscopy   [ Time Frame: 30 days ]

2.  Secondary:   Number of Patients With Positive CT Result   [ Time Frame: 30 days ]

3.  Secondary:   Number of Participants With Positive Bacterial Results by PCR   [ Time Frame: 24-48 hours ]

4.  Secondary:   Number of Patients With Positive Fungal Results by PCR   [ Time Frame: 24-48 hours ]

5.  Secondary:   Number of Participants With Positive Viral Results by PCR   [ Time Frame: 24-48 hours ]

6.  Secondary:   Number of Participants With Positive Myocbacteria Results by Culture   [ Time Frame: 24-48 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: H. Kent Holland, MD
Organization: Northside Hospital
phone: 404-255-1930
e-mail: kholland@bmtga.com


Publications:

Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01328873     History of Changes
Other Study ID Numbers: NSH 909
First Submitted: March 1, 2011
First Posted: April 5, 2011
Results First Submitted: October 5, 2016
Results First Posted: April 26, 2017
Last Update Posted: July 11, 2017