NCT06188182

Brief Summary

  1. 1.The effect of D-index on the onset and severity of FN in AML patients.
  2. 2.Relationship between the c-D-index and duration of FN in AML patients.
  3. 3.Correlation between D-index and MDR.
  4. 4.Correlation between D-index and invasive fungal infection.
  5. 5.Comparison of FN in different treatment protocols for AML using D-index.
  6. 6.Prediction of pulmonary, fungal or blood stream infection.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Jun 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jun 2024Jun 2026

First Submitted

Initial submission to the registry

December 14, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

December 14, 2023

Last Update Submit

January 1, 2024

Conditions

AML, Adult

Outcome Measures

Primary Outcomes (1)

  • The effect of D-index on the onset and severity of FN in AML patients.

    Determine if the D-index can predict the onset, severity, duration and complications of febrile neutropenia

    during the period of chemotherapy completion, an average of 1 year

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients meeting the inclusion criteria will be recruited in the study. The period of data collection will be continued for 12 months.

You may qualify if:

  • Adult Patients (≥18 years) newly diagnosed as acute myeloid leukemia according to WHO 2016 diagnostic criteria.
  • Hematologic diagnosis of de novo AML.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
  • Standard induction chemotherapy (7+3 regimen) or consolidation regimens (HiDAC).

You may not qualify if:

  • \) AML on top of other hematological disorders. 2) Acute promyelocytic leukemia. 3) Patients who received palliative care or low-intensity treatment. 4) Poor PS (≥3) at the time of diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Deschler B, Lubbert M. Acute myeloid leukemia: epidemiology and etiology. Cancer. 2006 Nov 1;107(9):2099-107. doi: 10.1002/cncr.22233.

    PMID: 17019734RESULT

  • Boeriu E, Borda A, Vulcanescu DD, Sarbu V, Arghirescu ST, Ciorica O, Bratosin F, Marincu I, Horhat FG. Diagnosis and Management of Febrile Neutropenia in Pediatric Oncology Patients-A Systematic Review. Diagnostics (Basel). 2022 Jul 25;12(8):1800. doi: 10.3390/diagnostics12081800.

    PMID: 35892511RESULT

  • Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of Americaa. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2011 Feb 15;52(4):427-31. doi: 10.1093/cid/ciq147. Epub 2011 Jan 4.

    PMID: 21205990RESULT

  • Amanati A, Sajedianfard S, Khajeh S, Ghasempour S, Mehrangiz S, Nematolahi S, Shahhosein Z. Bloodstream infections in adult patients with malignancy, epidemiology, microbiology, and risk factors associated with mortality and multi-drug resistance. BMC Infect Dis. 2021 Jul 2;21(1):636. doi: 10.1186/s12879-021-06243-z.

    PMID: 34215207RESULT

  • Guarnera L, Trotta GE, Boldrini V, Cardillo L, Cerroni I, Mezzanotte V, Pasqualone G, Savi A, Borsellino B, Buzzatti E, Palmieri R, Paterno G, Maurillo L, Buccisano F, Venditti A, Del Principe MI. Fever of Unknown Origin and Multidrug Resistant Organism Colonization in AML Patients. Mediterr J Hematol Infect Dis. 2023 Jan 1;15(1):e2023013. doi: 10.4084/MJHID.2023.013. eCollection 2023.

    PMID: 36660358RESULT

  • Rattanathammethee T, Munsamai K, Punnachet T, Hantrakun N, Piriyakhuntorn P, Hantrakool S, Chai-Adisaksopha C, Rattarittamrong E, Tantiworawit A, Norasetthada L. D-index and invasive fungal infections (IFIs) in adult acute myeloid leukemia (AML) patients with the first episode of febrile neutropenia. PLoS One. 2023 May 22;18(5):e0286089. doi: 10.1371/journal.pone.0286089. eCollection 2023.

    PMID: 37216345RESULT

  • Portugal RD, Garnica M, Nucci M. Index to predict invasive mold infection in high-risk neutropenic patients based on the area over the neutrophil curve. J Clin Oncol. 2009 Aug 10;27(23):3849-54. doi: 10.1200/JCO.2008.21.0856. Epub 2009 Jul 13.

    PMID: 19597026RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Esraa Nageh

CONTACT

01012386384esraanageh24434@gmail.com

Yomna Refaat

CONTACT

01060178482yomna-rm@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecture

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 3, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

January 3, 2024

Record last verified: 2024-01