Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 an outpatient setting after an initial phase of intravenous antibiotics and in-hospital observation for 8 to 22 hours, is not inferior as to safety and efficacy compared to continued intravenous antibiotics given in-hospital.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Pediatric Oncology Group
• Collaborators: Bayer; GlaxoSmithKline; Swiss Cancer League
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Ciprofloxacin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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