Spots Global Cancer Trial Database for Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
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Trial Identification
Brief Title: Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
Official Title: A Prospective Multi-Center Study on Pediatric Patients With Fever in Severe Chemotherapy Induced Neutropenia, Including a Randomized Comparison of Outpatient Management and Oral Antimicrobial Therapy Versus Inpatient Management and Intravenous Antimicrobial Therapy in a Subgroup With Low Risk of Adverse Events (Low-Risk Subgroup Study)
Study ID: NCT00107081
Study Description
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 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.
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 antibiotics are given. Type and dosage are chosen by the treating physician. * Patients randomized to continued intravenous antibiotics continue with these antibiotics. * Patients randomized to oral antibiotics receive a combination of oral ciprofloxacin (25 to 30 mg/kg/day, top dose 1500 mg/day) plus oral amoxicillin (65 to 80 mg/kg/day, top dose 2250 mg/day), both given in two doses per day. * In both groups, the study gives guidelines (for certain situations) and rules (for other situations) when to change and when to stop antibiotics. Details on clinical and laboratory controls * During antibiotic therapy, patients are seen daily, either as inpatients or as outpatients according to randomization. Complete blood counts are performed at least every second day. * After stopping antibiotic therapy and until resolution of severe neutropenia (if applicable), patients are seen every other day, with a complete blood count. * Patients randomized to outpatient management have the possibility to contact at any time of the day (and night) a pediatric oncologist in case of problems, in order to discuss necessity for emergency control and/or rehospitalization.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pediatric Hematology/Oncology, University Children's Hospital, Bonn, , Germany
Pediatric Hematology/Oncology, University Children's Hospital, Duesseldorf, , Germany
Pediatric Hematology/Oncology, University Children's Hospital, Freiburg, , Germany
Pediatric Hematology/Oncology, University Children's Hospital von Hauner, Munich, , Germany
Pediatric Hematology/Oncology, University Hospital St. Hedwig, Regensburg, , Germany
Pediatric Hematology/Oncology, University Children's Hospital, Groningen, , Netherlands
Pediatric Hematology/Oncology, University Children's Hospital, Basel, , Switzerland
Pediatric Hematology/Oncology, University Children's Hospital, Bern, , Switzerland
Pediatric Hematology/Oncology, University Children's Hospital, Geneva, , Switzerland
Pediatric Hematology/Oncology, University Children's Hospital, Lausanne, , Switzerland
Pediatric Hematology/Oncology, Children's Hospital, Lucerne, , Switzerland
Pediatric Hematology/Oncology, University Children's Hospital, Zurich, , Switzerland
Contact Details
Name: Roland A Ammann, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, Switzerland
Role: STUDY_CHAIR
Name: Christoph Aebi, MD
Affiliation: University Children's Hospital, Bern, Switzerland
Role: STUDY_DIRECTOR
Name: Maja Beck-Popovic, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Lausanne, Switzerland
Role: PRINCIPAL_INVESTIGATOR
Name: Eveline SJM de Bont, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Groningen, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Kuehne, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Basel, Switzerland
Role: PRINCIPAL_INVESTIGATOR
Name: David Nadal, MD
Affiliation: University Children's Hospital, Zurich
Role: STUDY_DIRECTOR
Name: Felix Niggli, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Zurich, Switzerland
Role: PRINCIPAL_INVESTIGATOR
Name: Arne Simon, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Bonn, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Nicole Bodmer, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Zurich, Switzerland
Role: STUDY_DIRECTOR
Name: Hulya Ozsahin, MD
Affiliation: Pediatric Hematology/Oncology, University Children's Hospital, Geneva, Switzerland
Role: PRINCIPAL_INVESTIGATOR
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