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

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

Detailed Description
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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.

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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Other: Planned Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A: with Periodontitis<br>Patients with periodontitis | Other: Planned Chemotherapy<br>* standard oncologic supportive care including antibiotic prophylaxis<br>|
| Arm B: without Periodontitis<br>Patients without periodontitis | Other: Planned Chemotherapy<br>* standard oncologic supportive care including antibiotic prophylaxis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Neutropenic fever | Number of participants experiencing Neutropenic fever (NF) by day 28 of chemotherapy | Day 28 of chemotherapy | 
| Number of participants exposed to different antibiotics | Number of participants with antibiotic exposure by day 28 of chemotherapy | Day 28 of chemotherapy | 
| Length of hospitalization | Number of days the patients were hospitalized | Day 28 of chemotherapy | 
| Number of participants who died | Number of participants who died by day 28 of chemotherapy | Day 28 of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BSI, Periodontitis, AML