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

University of Minnesota (UMN)

Status: Terminated

Conditions: Acute Myeloid Leukemia

Treatments: Other: Planned Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT04858594

HM2020-37 (Other Identifier)

2020LS191

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

3 participants in 2 patient groups

Arm A: with Periodontitis

Description:

Patients with periodontitis

Treatment:

Other: Planned Chemotherapy

Arm B: without Periodontitis

Description:

Patients without periodontitis

Treatment:

Other: Planned Chemotherapy