NCT02536599

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

8 years

First QC Date

August 27, 2015

Last Update Submit

July 21, 2023

Conditions

Febrile Neutropenia

Keywords

Febrile NeutropeniaChildhood CancerPediatric OncologyFeverNeutropenia

Outcome Measures

Primary Outcomes (1)

  • Clinically documented infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.

    Recovery from fever neutropenia episode OR occurrence of clinically documented infection

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (1)

  • Death as a complication for infections

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric cancer patients who have episodes of fever \& neutropenia

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Related Publications (8)

  • Kern WV. Risk assessment and risk-based therapeutic strategies in febrile neutropenia. Curr Opin Infect Dis. 2001 Aug;14(4):415-22. doi: 10.1097/00001432-200108000-00003.

    PMID: 11964858BACKGROUND

  • 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.

    PMID: 16943529BACKGROUND

  • 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.

    PMID: 10944139BACKGROUND

  • 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

    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.

    PMID: 9764547BACKGROUND

  • 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.

    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.

    PMID: 3196123BACKGROUND

  • 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.

    PMID: 1732432BACKGROUND

MeSH Terms

Conditions

Febrile NeutropeniaNeoplasmsFeverNeutropenia

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Pediatric Oncology Department

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 1, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

EG(1)