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

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: Planned Chemotherapy

• Registration Number: NCT04858594
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Status Verified: 2021-05
• Study Start: 2021-05-04
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A: with Periodontitis	Planned Chemotherapy	Patients with periodontitis
Arm B: without Periodontitis	Planned Chemotherapy	Patients without periodontitis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of participants with Neutropenic fever	Day 28 of chemotherapy	Number of participants experiencing Neutropenic fever (NF) 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
Number of participants exposed to different antibiotics	Day 28 of chemotherapy	Number of participants with antibiotic exposure by day 28 of chemotherapy

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States