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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 : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Morsy, MD, Assiut University

Tracking Information
First Submitted Date August 27, 2015
First Posted Date September 1, 2015
Last Update Posted Date January 10, 2020
Study Start Date October 2015
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 28, 2015)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
Official Title Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric cancer patients who have episodes of fever & neutropenia
Condition Febrile Neutropenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 28, 2015)
360
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients whose age is more than 18 years.
  • Patients not fulfilling the criteria for diagnosis of fever and neutropenia.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT02536599
Other Study ID Numbers Doc Inf FN Ped Onc
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ahmed Mohammed Morsy, MD, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date January 2020