Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02536599|
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : January 11, 2019
|Condition or disease|
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|
|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 2019|
|Estimated Study Completion Date :||August 2019|
- 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
- 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
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
|Assiut, Egypt, 71515|
|Contact: Ahmed M. Morsy, MD 20 01003314522 firstname.lastname@example.org|
|Principal Investigator: Ahmed M. Morsy, MD|
|Principal Investigator: Ameer M. Abuelgheet, MD|