Acute Myeloid Leukemia
Conditions
Keywords
BSI, Periodontitis, AML
Brief summary
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.
Detailed description
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.
Interventions
OTHERPlanned Chemotherapy
standard oncologic supportive care including antibiotic prophylaxis
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Blood stream infections | Day 28 of chemotherapy | Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Neutropenic fever | Day 28 of chemotherapy | Number of participants experiencing Neutropenic fever (NF) by day 28 of chemotherapy |
| Number of participants exposed to different antibiotics | Day 28 of chemotherapy | Number of participants with antibiotic exposure by day 28 of chemotherapy |
| Length of hospitalization | Day 28 of chemotherapy | Number of days the patients were hospitalized |
| Number of participants who died | Day 28 of chemotherapy | Number of participants who died by day 28 of chemotherapy |
Countries
United States
Outcome results
None listed