AML, AdultNCT06188182
D-index as a Predictor of Complication of Treatment of Patients With Acute Myeloid Leukemia
An observational study of AML, Adult, run by Assiut University.
Trial summary
1. The effect of D-index on the onset and severity of FN in AML patients. 2. Relationship between the c-D-index and duration of FN in AML patients. 3. Correlation between D-index and MDR. 4. Correlation between D-index and invasive fungal infection. 5. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AML, Adult
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 1) 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.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: D-index as a Predictor of Complications of Febrile Neutropenia in Patients With Acute Myeloid Leukemia
- The effect of D-index on the onset and severity of FN in AML patients.
- Relationship between the c-D-index and duration of FN in AML patients.
- Correlation between D-index and MDR.
- Correlation between D-index and invasive fungal infection.
- Comparison of FN in different treatment protocols for AML using D-index.
- Prediction of pulmonary, fungal or blood stream infection.
Read the detailed description
Acute myeloid leukemia (AML) is highly malignant neoplasm responsible for a large number of cancer-related deaths. It continuously shows 2 peaks in occurrence in early childhood and later adulthood. With an incidence of 3.7 per 100,000 persons per year.
Neutropenia, defined as the absolute neutrophil count (ANC) below 500 cells/ μL or ANC expected to drop below 500 cells/ μL in the next 48 h, represents a potentially fatal complication and is associated with a high risk of developing bacterial infections. Fever is defined as having a bodily temperature above 38.3 ˚C, measured orally, or two measurements above 38 ˚C that are taken at different time points, at least an hour apart.
Concomitance of severe neutropenia (≤ 500 cells/ μL) with high fever (≥ 38.3˚C) is called febrile neutropenia (FN) by the definition of the Infectious Diseases Society of America (IDSA).
Invasive fungal infection (IFI) and bacterial blood stream infection (BSI) consideded a major complications during AML treatment and associated with high morbidity and mortality. Immunosuppression caused by chemotherapy and prolonged hospitalizations expose AML patients to life threatening infections, which can be sustained by multi-drug resistant organisms (MDROs), accounting for one of the major causes of mortality.
A clinical parameter that evaluates the dynamics of neutropenia, combining intensity and duration, could be a good tool to identify patients at high risk for infection. This tool could be used to stratify patients, helping clinicians to select appropriate antibiotics and antifungal therapy in persistently febrile neutropenic patients. An index (called the D-index) that uses data from WBC counts and combines intensity and duration of neutropenia.
The D-index was developed by the calculated area over the neutrophil curve from the plot of ANC<500 /μl and duration of grade 4 neutropenia. Cumulative D-index (c-D-index) was also defined from the grade 4 neutropenia to the onset of febrile neutropenia, it reflects an accumulation of neutropenia until FN. Therefore, this study aim to describe and investigate the impacts of D-index performance on infectious complications in adult AML patients who developed the first episode of FN after receiving high-intensity chemotherapy.
- Conditions
- AML, Adult
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the period of chemotherapy completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Nageh Adam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188182
- Sponsor's protocol ID
- neutropnic fever in AML
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deschler B, Lubbert M. Acute myeloid leukemia: epidemiology and etiology. Cancer. 2006 Nov 1;107(9):2099-107. doi: 10.1002/cncr.22233.
PubMed 17019734Boeriu 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.
PubMed 35892511Freifeld 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.
PubMed 21205990Amanati 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.
PubMed 34215207Guarnera 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.
PubMed 36660358Rattanathammethee 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.
PubMed 37216345Portugal 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.
PubMed 19597026
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-index as a Predictor of Complications of Febrile Neutropenia in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06188182
- Acronym / sponsor ID
- neutropnic fever in AML
- Conditions
- AML, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The effect of D-index on the onset and severity of FN in AML patients.
- Relationship between the c-D-index and duration of FN in AML patients.
- Correlation between D-index and MDR.
- Correlation between D-index and invasive fungal infection.
- Comparison of FN in different treatment protocols for AML using D-index.
- Prediction of pulmonary, fungal or blood stream infection.
Detailed description
Acute myeloid leukemia (AML) is highly malignant neoplasm responsible for a large number of cancer-related deaths. It continuously shows 2 peaks in occurrence in early childhood and later adulthood. With an incidence of 3.7 per 100,000 persons per year.
Neutropenia, defined as the absolute neutrophil count (ANC) below 500 cells/ μL or ANC expected to drop below 500 cells/ μL in the next 48 h, represents a potentially fatal complication and is associated with a high risk of developing bacterial infections. Fever is defined as having a bodily temperature above 38.3 ˚C, measured orally, or two measurements above 38 ˚C that are taken at different time points, at least an hour apart.
Concomitance of severe neutropenia (≤ 500 cells/ μL) with high fever (≥ 38.3˚C) is called febrile neutropenia (FN) by the definition of the Infectious Diseases Society of America (IDSA).
Invasive fungal infection (IFI) and bacterial blood stream infection (BSI) consideded a major complications during AML treatment and associated with high morbidity and mortality. Immunosuppression caused by chemotherapy and prolonged hospitalizations expose AML patients to life threatening infections, which can be sustained by multi-drug resistant organisms (MDROs), accounting for one of the major causes of mortality.
A clinical parameter that evaluates the dynamics of neutropenia, combining intensity and duration, could be a good tool to identify patients at high risk for infection. This tool could be used to stratify patients, helping clinicians to select appropriate antibiotics and antifungal therapy in persistently febrile neutropenic patients. An index (called the D-index) that uses data from WBC counts and combines intensity and duration of neutropenia.
The D-index was developed by the calculated area over the neutrophil curve from the plot of ANC<500 /μl and duration of grade 4 neutropenia. Cumulative D-index (c-D-index) was also defined from the grade 4 neutropenia to the onset of febrile neutropenia, it reflects an accumulation of neutropenia until FN. Therefore, this study aim to describe and investigate the impacts of D-index performance on infectious complications in adult AML patients who developed the first episode of FN after receiving high-intensity chemotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 1) 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The effect of D-index on the onset and severity of FN in AML patients.
Time frame: during the period of chemotherapy completion, an average of 1 year
Determine if the D-index can predict the onset, severity, duration and complications of febrile neutropenia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Results publication: PubMed 17019734Deschler B, Lubbert M. Acute myeloid leukemia: epidemiology and etiology. Cancer. 2006 Nov 1;107(9):2099-107. doi: 10.1002/cncr.22233.
- Results publication: PubMed 35892511Boeriu 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.
- Results publication: PubMed 21205990Freifeld 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.
- Results publication: PubMed 34215207Amanati 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.
- Results publication: PubMed 36660358Guarnera 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.
- Results publication: PubMed 37216345Rattanathammethee 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.
- Results publication: PubMed 19597026Portugal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, Adult, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Nageh (01012386384, esraanageh24434@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of D-index on the onset and severity of FN in AML patients. (time frame: during the period of chemotherapy completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188182, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.