Clinical trial · Observational
Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
NCT02536599CI-TRIAL-00068200unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinically documented infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.
- timeFrame
- Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
- description
- Recovery from fever neutropenia episode OR occurrence of clinically documented infection
Secondary outcomes (1)
- measure
- Death as a complication for infections
- timeFrame
- Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
- description
- Recovery from fever \& neutropenia OR death as a complication of severe infection
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDKern 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 11964858
- BACKGROUNDKlastersky 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 16943529
- BACKGROUNDKlastersky 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 10944139
- BACKGROUNDKleinberg M, Bow EJ. Introduction: Approach to the Patient. In Kleinberg M (ed) Managing Infections in Patients With Hematological Malignancies. Humana Press 2010; 1-12
- BACKGROUNDRolston 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 9764547
- BACKGROUNDRolston 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.
- BACKGROUNDTalcott 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 3196123
- BACKGROUNDTalcott 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.