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

Sponsor

Masonic Cancer Center, University of Minnesota (Other)

Overall Status

Terminated

CT.gov ID

NCT04858594

Collaborator

(none)

Enrollment

Location

9.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Other: Planned 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.

Study Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia

Actual Study Start Date :

May 4, 2021

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Arm A: with Periodontitis Patients with periodontitis	Other: Planned Chemotherapy standard oncologic supportive care including antibiotic prophylaxis
Arm B: without Periodontitis Patients without periodontitis	Other: Planned Chemotherapy standard oncologic supportive care including antibiotic prophylaxis

Arm

Intervention/Treatment

Arm A: with Periodontitis

Patients with periodontitis

Other: Planned Chemotherapy

standard oncologic supportive care including antibiotic prophylaxis

Arm B: without Periodontitis

Patients without periodontitis

Other: Planned Chemotherapy

standard oncologic supportive care including antibiotic prophylaxis

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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