Clinical trial · Observational
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
NCT04858594CI-TRIAL-00057698terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left and research was stopped
Summary
Brief summary (as posted)
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Planned Chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm A: with Periodontitis
- description
- Patients with periodontitis
- interventionNames
- Other: Planned Chemotherapy
- label
- Arm B: without Periodontitis
- description
- Patients without periodontitis
- interventionNames
- Other: Planned Chemotherapy
Primary outcomes (1)
- measure
- Number of participants with Blood stream infections
- timeFrame
- Day 28 of chemotherapy
- description
- Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.