Febrile NeutropeniaNCT02536599
Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
An observational study of Febrile Neutropenia, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the study is to identify clinical and laboratory parameters, present at the time of initial evaluation that could help predict which children with cancer, fever, and neutropenia will be at risk for developing clinically documented infections and/ or complications. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Febrile Neutropenia
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Nov 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric cancer patients who have episodes of fever \& neutropenia
Who may be able to join
- Patients whose age less than 19 years.
- Patients diagnosed with hematologic malignancies or solid tumors.
- Patients admitted at the pediatric oncology department for at least 24-hour period after documentation of an episode of fever \& neutropenia at the time of initial evaluation at the pediatric oncology clinic.
- Patients who previously have been admitted at the pediatric oncology department, after documentation of an episode of fever \& neutropenia.
Who cannot join
- Patients whose age is more than 18 years.
- Patients not fulfilling the criteria for diagnosis of fever and neutropenia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Ahmed M. Morsy, MD, 20 01003314522, ahmedmohammed7829@yahoo.com
Ahmed M. Morsy, MD
About this study
The aim of the study is to identify clinical and laboratory parameters, present at the time of initial evaluation that could help predict which children with cancer, fever, and neutropenia will be at risk for developing clinically documented infections and/ or complications.
Read the detailed description
Background:
It has long been recognized that not all neutropenic patients have the same risk of developing serious infections and/or complications.
Fever and infection represent the most important complications of myeloablative cytotoxic therapy that results in severe mucositis and prolonged neutropenia .
One of the most important concepts in the approach to infections in the febrile neutropenic patient is the recognition of risk. Risk can be defined in two ways. First, risk may be defined in terms of the probability for developing a febrile neutropenic infection; and second, it may be defined in terms of the likelihood for significantly poor outcomes due to that infection.
An understanding of the risks in the latter case may be used to define the approaches to management; for instance, in-patient versus out-patient treatment strategies and administration of intravenous versus oral formulations of antimicrobial therapy. These considerations have significant economic and quality of life ramifications.
Many institutions have developed simple clinical criteria to identify low-risk patients without having to calculate a risk-index score. This might be a more practical method in busy clinical settings, or as a tool in setting of low resource country.
Patients \& Methods:
The study will include children, either referred from the pediatric oncology clinic, or who have been previously admitted to the pediatric oncology department, those who have been documented with episodes of fever and neutropenia at South Egypt Cancer Institute (SECI), and fulfilling all criteria for enrollment in this study.
All the patients at the time of initial evaluation will be subjected to complete clinical history and full clinical examination.
The enrolled patients will be followed for either developing clinically evident infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.), or until resolution of fever and/ or neutropenia. The risk for either developing clinically evident infection, or not, will be assessed according to clinical and laboratory parameters, present at the time of initial evaluation to identify those patients who would be more prone to develop infection and/ or complications Fever is defined as a temperature greater than or equal to 38.3 C occurring once or a temperature greater than or equal to 38 C occurring twice during a 24-hour period.
Patients with an absolute neutrophilic count (ANC) of less than 500/mm3 and those with an ANC of less than 1,000/mm3 and decreasing will be considered neutropenic.
Complete blood count \& other diagnostic studies, including laboratory studies and imaging procedures will be obtained if needed to further evaluate and determine the source of fever and/or infection.
- Conditions
- Febrile Neutropenia
- Keywords
- Febrile Neutropenia, Childhood Cancer, Pediatric Oncology, Fever, Neutropenia
- Medical subject headings
- Febrile Neutropenia, Neoplasms, Fever, Neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically documented infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.
Recovery from fever neutropenia episode OR occurrence of clinically documented infection
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (1)
Death as a complication for infections
Recovery from fever \& neutropenia OR death as a complication of severe infection
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Febrile NeutropeniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Morsy, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536599
- Sponsor's protocol ID
- Doc Inf FN Ped Onc
- Status last verified
- Jul 2023
- First submitted
- 27 Aug 2015
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Kern WV. Risk assessment and risk-based therapeutic strategies in febrile neutropenia. Curr Opin Infect Dis. 2001 Aug;14(4):415-22. doi: 10.1097/00001432-200108000-00003.
PubMed 11964858Klastersky J, Paesmans M, Georgala A, Muanza F, Plehiers B, Dubreucq L, Lalami Y, Aoun M, Barette M. Outpatient oral antibiotics for febrile neutropenic cancer patients using a score predictive for complications. J Clin Oncol. 2006 Sep 1;24(25):4129-34. doi: 10.1200/JCO.2005.03.9909.
PubMed 16943529Klastersky J, Paesmans M, Rubenstein EB, Boyer M, Elting L, Feld R, Gallagher J, Herrstedt J, Rapoport B, Rolston K, Talcott J. The Multinational Association for Supportive Care in Cancer risk index: A multinational scoring system for identifying low-risk febrile neutropenic cancer patients. J Clin Oncol. 2000 Aug;18(16):3038-51. doi: 10.1200/JCO.2000.18.16.3038.
PubMed 10944139Kleinberg M, Bow EJ. Introduction: Approach to the Patient. In Kleinberg M (ed) Managing Infections in Patients With Hematological Malignancies. Humana Press 2010; 1-12
Rolston KV. Risk assessment and risk-based therapy in febrile neutropenic patients. Eur J Clin Microbiol Infect Dis. 1998 Jul;17(7):461-3. doi: 10.1007/BF01691127. No abstract available.
PubMed 9764547Rolston KI, Bodey G. Management of the Neutropenic Patient with Fever. In Safdar A (ed) Principles and Practice of Cancer Infectious Diseases. Humana Press 2011; 95-103.
Talcott JA, Finberg R, Mayer RJ, Goldman L. The medical course of cancer patients with fever and neutropenia. Clinical identification of a low-risk subgroup at presentation. Arch Intern Med. 1988 Dec;148(12):2561-8.
PubMed 3196123Talcott JA, Siegel RD, Finberg R, Goldman L. Risk assessment in cancer patients with fever and neutropenia: a prospective, two-center validation of a prediction rule. J Clin Oncol. 1992 Feb;10(2):316-22. doi: 10.1200/JCO.1992.10.2.316.
PubMed 1732432
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
- ClinicalTrials.gov ID
- NCT02536599
- Acronym / sponsor ID
- Doc Inf FN Ped Onc
- Conditions
- Febrile Neutropenia
- Keywords
- Febrile Neutropenia, Childhood Cancer, Pediatric Oncology, Fever, Neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 1 Sep 2015 (estimated)
- 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 aim of the study is to identify clinical and laboratory parameters, present at the time of initial evaluation that could help predict which children with cancer, fever, and neutropenia will be at risk for developing clinically documented infections and/ or complications.
Detailed description
Background:
It has long been recognized that not all neutropenic patients have the same risk of developing serious infections and/or complications.
Fever and infection represent the most important complications of myeloablative cytotoxic therapy that results in severe mucositis and prolonged neutropenia .
One of the most important concepts in the approach to infections in the febrile neutropenic patient is the recognition of risk. Risk can be defined in two ways. First, risk may be defined in terms of the probability for developing a febrile neutropenic infection; and second, it may be defined in terms of the likelihood for significantly poor outcomes due to that infection.
An understanding of the risks in the latter case may be used to define the approaches to management; for instance, in-patient versus out-patient treatment strategies and administration of intravenous versus oral formulations of antimicrobial therapy. These considerations have significant economic and quality of life ramifications.
Many institutions have developed simple clinical criteria to identify low-risk patients without having to calculate a risk-index score. This might be a more practical method in busy clinical settings, or as a tool in setting of low resource country.
Patients \& Methods:
The study will include children, either referred from the pediatric oncology clinic, or who have been previously admitted to the pediatric oncology department, those who have been documented with episodes of fever and neutropenia at South Egypt Cancer Institute (SECI), and fulfilling all criteria for enrollment in this study.
All the patients at the time of initial evaluation will be subjected to complete clinical history and full clinical examination.
The enrolled patients will be followed for either developing clinically evident infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.), or until resolution of fever and/ or neutropenia. The risk for either developing clinically evident infection, or not, will be assessed according to clinical and laboratory parameters, present at the time of initial evaluation to identify those patients who would be more prone to develop infection and/ or complications Fever is defined as a temperature greater than or equal to 38.3 C occurring once or a temperature greater than or equal to 38 C occurring twice during a 24-hour period.
Patients with an absolute neutrophilic count (ANC) of less than 500/mm3 and those with an ANC of less than 1,000/mm3 and decreasing will be considered neutropenic.
Complete blood count \& other diagnostic studies, including laboratory studies and imaging procedures will be obtained if needed to further evaluate and determine the source of fever and/or infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric cancer patients who have episodes of fever \& neutropenia
Key inclusion criteria (4 listed)
- Patients whose age less than 19 years.
- Patients diagnosed with hematologic malignancies or solid tumors.
- Patients admitted at the pediatric oncology department for at least 24-hour period after documentation of an episode of fever \& neutropenia at the time of initial evaluation at the pediatric oncology clinic.
- Patients who previously have been admitted at the pediatric oncology department, after documentation of an episode of fever \& neutropenia.
Key exclusion criteria (2 listed)
- Patients whose age is more than 18 years.
- Patients not fulfilling the criteria for diagnosis of fever and neutropenia.
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
Clinically documented infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Recovery from fever neutropenia episode OR occurrence of clinically documented infection
1 secondary outcome
Death as a complication for infections
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 11964858Kern WV. Risk assessment and risk-based therapeutic strategies in febrile neutropenia. Curr Opin Infect Dis. 2001 Aug;14(4):415-22. doi: 10.1097/00001432-200108000-00003.
- Background: PubMed 16943529Klastersky J, Paesmans M, Georgala A, Muanza F, Plehiers B, Dubreucq L, Lalami Y, Aoun M, Barette M. Outpatient oral antibiotics for febrile neutropenic cancer patients using a score predictive for complications. J Clin Oncol. 2006 Sep 1;24(25):4129-34. doi: 10.1200/JCO.2005.03.9909.
- Background: PubMed 10944139Klastersky J, Paesmans M, Rubenstein EB, Boyer M, Elting L, Feld R, Gallagher J, Herrstedt J, Rapoport B, Rolston K, Talcott J. The Multinational Association for Supportive Care in Cancer risk index: A multinational scoring system for identifying low-risk febrile neutropenic cancer patients. J Clin Oncol. 2000 Aug;18(16):3038-51. doi: 10.1200/JCO.2000.18.16.3038.
- BackgroundKleinberg M, Bow EJ. Introduction: Approach to the Patient. In Kleinberg M (ed) Managing Infections in Patients With Hematological Malignancies. Humana Press 2010; 1-12
- Background: PubMed 9764547Rolston KV. Risk assessment and risk-based therapy in febrile neutropenic patients. Eur J Clin Microbiol Infect Dis. 1998 Jul;17(7):461-3. doi: 10.1007/BF01691127. No abstract available.
- BackgroundRolston KI, Bodey G. Management of the Neutropenic Patient with Fever. In Safdar A (ed) Principles and Practice of Cancer Infectious Diseases. Humana Press 2011; 95-103.
- Background: PubMed 3196123Talcott JA, Finberg R, Mayer RJ, Goldman L. The medical course of cancer patients with fever and neutropenia. Clinical identification of a low-risk subgroup at presentation. Arch Intern Med. 1988 Dec;148(12):2561-8.
- Background: PubMed 1732432Talcott JA, Siegel RD, Finberg R, Goldman L. Risk assessment in cancer patients with fever and neutropenia: a prospective, two-center validation of a prediction rule. J Clin Oncol. 1992 Feb;10(2):316-22. doi: 10.1200/JCO.1992.10.2.316.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia, run by Assiut University at 1 site in Egypt.
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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically documented infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 NCT02536599, which also lists 8 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 24 Jul 2023.