Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy

Masonic Cancer Center, University of Minnesota3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Planned ChemotherapyOTHER

standard oncologic supportive care including antibiotic prophylaxis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>18 years * Diagnosis of AML, new diagnosis or relapsed/refractory disease * Planned intensive inpatient chemotherapy, defined as expected hospitalization for 4 weeks or longer * Sufficient time to perform periodontal examination and treatment by the end of day 1 of chemotherapy without delaying chemotherapy * Written informed consent prior to performance of any research related activities Exclusion Criteria: * Unstable for transfer to the School of Dentistry * Fever at the time of enrollment * Documented blood stream infection at the time of enrollment * Inherited bleeding diathesis * Periodontitis requiring treatment before starting chemotherapy * ANC \<0.5 x 10\^9/L at the time of enrollment * Unstable for transfer to the School of Dentistry * Fever at the time of enrollment * Documented blood stream infection at the time of enrollment * Inherited bleeding diathesis * Periodontitis requiring treatment before starting chemotherapy

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States