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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:

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 i
Sponsor: Assiut University

Current 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


Original Primary Outcome: Same as current

Current 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 ]

Recovery from fever & neutropenia OR death as a complication of severe infection


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: August 27, 2015
Date Started: October 2015
Date Completion: August 2017
Last Updated: February 24, 2017
Last Verified: February 2017