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

NCT ID: NCT02536599

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2023-11-30

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.

Conditions

Febrile Neutropenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohammed Morsy, MD

Lecturer, Pediatric Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Ahmed M. Morsy, MD

Role: primary

ahmedmohammed7829@yahoo.com

20 01003314522

References

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Reference Type: BACKGROUND

PMID: 11964858 (View on PubMed)

Klastersky 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.

Reference Type: BACKGROUND

PMID: 16943529 (View on PubMed)

Klastersky 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.

Reference Type: BACKGROUND

PMID: 10944139 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 9764547 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 3196123 (View on PubMed)

Talcott 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.

Reference Type: BACKGROUND

PMID: 1732432 (View on PubMed)

Other Identifiers

Doc Inf FN Ped Onc

Identifier Type: -

Identifier Source: org_study_id