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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04858594
• Other study ID #: 2020LS191
• Secondary ID: HM2020-37
• Status: Terminated
• Start date: May 4, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2021
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Periodontitis

Intervention

Other:
• Planned Chemotherapy
standard oncologic supportive care including antibiotic prophylaxis

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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