Clinical trial NCT04858594: Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy
Official title: Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Myeloid Leukemia
Keywords: BSI
Periodontitis
AML
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Number of participants with Blood stream infections
timeFrame: Day 28 of chemotherapy
Secondary outcomes:
measure: Number of participants with Neutropenic fever
timeFrame: Day 28 of chemotherapy
measure: Number of participants exposed to different antibiotics
timeFrame: Day 28 of chemotherapy
measure: Length of hospitalization
timeFrame: Day 28 of chemotherapy
measure: Number of participants who died
timeFrame: Day 28 of chemotherapy
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Armin Rashidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: