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

NCT ID: NCT04858594

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2022-02-28

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm A: with Periodontitis

Patients with periodontitis

Planned Chemotherapy

Intervention Type: OTHER

standard oncologic supportive care including antibiotic prophylaxis

Arm B: without Periodontitis

Patients without periodontitis

Planned Chemotherapy

Intervention Type: OTHER

standard oncologic supportive care including antibiotic prophylaxis

Interventions

Planned Chemotherapy

standard oncologic supportive care including antibiotic prophylaxis

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armin Rashidi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

HM2020-37

Identifier Type: OTHER

Identifier Source: secondary_id

2020LS191

Identifier Type: -

Identifier Source: org_study_id