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Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia

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ClinicalTrials.gov Identifier: NCT02536599
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Morsy, MD, Assiut University

Brief 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.

Condition or disease
Febrile Neutropenia

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 Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
Study Start Date : October 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Death as a complication for infections [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Recovery from fever & neutropenia OR death as a complication of severe infection



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric cancer patients who have episodes of fever & neutropenia
Criteria

Inclusion Criteria:

  • Patients whose age less than or equal to 18 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.

Exclusion Criteria:

  • Patients whose age is more than 18 years.
  • Patients not fulfilling the criteria for diagnosis of fever and neutropenia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536599


Locations
Egypt
Assiut University Recruiting
Assiut, Egypt, 71515
Contact: Ahmed M. Morsy, MD    20 01003314522    ahmedmohammed7829@yahoo.com   
Principal Investigator: Ahmed M. Morsy, MD         
Principal Investigator: Ameer M. Abuelgheet, MD         
Sponsors and Collaborators
Assiut University

Publications:
Kleinberg 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 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.

Responsible Party: Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
ClinicalTrials.gov Identifier: NCT02536599     History of Changes
Other Study ID Numbers: Doc Inf FN Ped Onc
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Keywords provided by Ahmed Mohammed Morsy, MD, Assiut University:
Febrile Neutropenia
Childhood Cancer
Pediatric Oncology
Fever
Neutropenia

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms