Status:
TERMINATED
Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
Lead Sponsor:
Swiss Pediatric Oncology Group
Collaborating Sponsors:
Swiss Cancer League
Bayer
Conditions:
Fever
Neutropenia
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether, in children with cancer presenting with fever in severe chemotherapy-induced neutropenia at low risk for medical complications, oral antibiotics in a...
Detailed Description
Details on antimicrobial therapy * At presentation with FN (fever and neutropenia) and during an initial inpatient observation period of 8 to 22 hours, empirical intravenous broad-spectrum antibiotic...
Eligibility Criteria
Inclusion
- Chemotherapy because of malignancy
- Severe neutropenia (absolute neutrophil count ≤ 0.5x10E9/L)
- Fever (axillary temperature ≥ 38.5°C once or ≥ 38.0°C during ≥ 2 hours)
- Able to swallow oral medication
- Written informed consent from patients and/or parents
Exclusion
- Status post myeloablative chemotherapy
- Diagnosis: acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or B-cell Non-Hodgkin lymphoma
- Bone marrow involvement by malignancy ≥ 25%
- Any comorbidity requiring hospitalization: \[1\] mean arterial blood pressure \< 50 mmHg (up to 10 years) / \< 60 mmHg (older than 10 years); \[2\] oxygen saturation \< 94% at room air; \[3\] radiologically defined pneumonia; \[4\] focal bacterial infection; \[5\] blood cultures taken at presentation reported positive at reassessment; \[6\] need for inpatient treatment or observation due to any other reason, as judged by the physician in charge
- Ever shaking chills
- Ever axillary temperature ≥ 39.5°C
- Antibacterial treatment before presentation with fever and neutropenia (except for prevention against Pneumocystis jiroveci \[formerly P. carinii\] pneumonia)
- Modification or de novo institution of a prophylaxis against P. jiroveci pneumonia
- Modification or de novo institution of a therapy with G-CSF or GM-CSF.
- Allergy to ciprofloxacin and/or amoxicillin
- Serum creatinine level above the upper limit of normal range
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00107081
Start Date
January 1 2004
End Date
December 1 2007
Last Update
November 2 2020
Active Locations (12)
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1
Pediatric Hematology/Oncology, University Children's Hospital
Bonn, Germany, D-53113
2
Pediatric Hematology/Oncology, University Children's Hospital
Düsseldorf, Germany, D-40225
3
Pediatric Hematology/Oncology, University Children's Hospital
Freiburg im Breisgau, Germany, D-79106
4
Pediatric Hematology/Oncology, University Children's Hospital von Hauner
Munich, Germany, D-80337