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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study entry is open to adult patients regardless of gender, race or ethnic background. While there will be every effort to seek out and include women and minority patients, the patient population is expected to be similar to that of other relapsed AML studies at the University Of Minnesota

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Blood stream infections	Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy	Day 28 of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Neutropenic fever	Number of participants experiencing Neutropenic fever (NF) by day 28 of chemotherapy	Day 28 of chemotherapy
Number of participants exposed to different antibiotics	Number of participants with antibiotic exposure by day 28 of chemotherapy	Day 28 of chemotherapy
Length of hospitalization	Number of days the patients were hospitalized	Day 28 of chemotherapy
Number of participants who died	Number of participants who died by day 28 of chemotherapy	Day 28 of chemotherapy

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Armin Rashidi, MD, PhD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: AML; Periodontitis; BSI
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 2020LS191; HM2020-37 (Other Identifier: University of Minnesota Masonic Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No