NCT04858594

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Planned Chemotherapy	standard oncologic supportive care including antibiotic prophylaxis

Timeline

• Start date: 2021-05-04
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-04-26
• Last updated: 2022-04-11

Locations

1 site across 1 country: United States