Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics i… (NCT00107081) | Clinical Trial Compass
TerminatedPhase 3
Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
Stopped: Accrual goal for interventional part not achievable
Germany70 participantsStarted 2004-01
Plain-language 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.
Who can participate
Age range1 Year – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Safety: No serious medical complication due to infection (death, treatment in ICU [Intensive Care Unit], potentially life-threatening complication) (non-inferiority-design, limit 3.5%)
2
Efficacy: Response without rehospitalization or changing randomized antibiotics (non-inferiority design, limit 10%)