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Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.
Once eligibility is confirmed, participants will undergo a specialized baseline periodontal examination, gingival sulcus microbiota sampling and saliva sample at baseline before starting chemotherapy. Patients will be separated into 2 cohorts, with periodontitis (Arm A) and without periodontitis (Arm B). All patients will receive standard oncologic supportive care including antibiotic prophylaxis. Serum samples will be obtained at baseline, at the onset of neutropenic fever, and weekly until day 28 or discharge (whichever sooner). Study participation will continue during the duration of standard of care chemotherapy for 28 days or until discharge from hospital, whichever later.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Start Date
May 4, 2021
Primary Completion Date
February 28, 2022
Completion Date
February 28, 2022
Last Updated
April 11, 2022
3
ACTUAL participants
Planned Chemotherapy
OTHER
Lead Sponsor
Masonic Cancer Center, University of Minnesota
NCT06285890
NCT06220162
NCT04065399
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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