Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
NCT ID: NCT00107081
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
70 participants
INTERVENTIONAL
2004-01-31
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard
Continued inpatient i.v. antibiotics
i.v. antibiotics
inpatient management
Experimental
Switch to outpatient p.o. antibiotics
ciprofloxacin and amoxicillin
Outpatient management
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ciprofloxacin and amoxicillin
Outpatient management
i.v. antibiotics
inpatient management
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
1 Year
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Swiss Cancer League
OTHER
Bayer
INDUSTRY
GlaxoSmithKline
INDUSTRY
Swiss Pediatric Oncology Group
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Swiss Pediatric Oncology Group; Roland A Ammann, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roland A Ammann, MD
Role: STUDY_CHAIR
Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, Switzerland
Christoph Aebi, MD
Role: STUDY_DIRECTOR
University Children's Hospital, Bern, Switzerland
Maja Beck-Popovic, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Hematology/Oncology, University Children's Hospital, Lausanne, Switzerland
Eveline SJM de Bont, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Hematology/Oncology, University Children's Hospital, Groningen, The Netherlands
Thomas Kuehne, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Hematology/Oncology, University Children's Hospital, Basel, Switzerland
David Nadal, MD
Role: STUDY_DIRECTOR
University Children's Hospital, Zurich
Felix Niggli, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Hematology/Oncology, University Children's Hospital, Zurich, Switzerland
Arne Simon, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Hematology/Oncology, University Children's Hospital, Bonn, Germany
Nicole Bodmer, MD
Role: STUDY_DIRECTOR
Pediatric Hematology/Oncology, University Children's Hospital, Zurich, Switzerland
Hulya Ozsahin, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatric Hematology/Oncology, University Children's Hospital, Geneva, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pediatric Hematology/Oncology, University Children's Hospital
Bonn, , Germany
Pediatric Hematology/Oncology, University Children's Hospital
Düsseldorf, , Germany
Pediatric Hematology/Oncology, University Children's Hospital
Freiburg im Breisgau, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ammann RA. SPOG 2003 FN: Risikobeurteilung und risikoadaptierte Behandlung bei Kindern und Jugendlichen mit Fieber in Neutropenie. Paediatrica 16(1): 28-31, 2005.
Ammann RA, Simon A, de Bont ES. Low risk episodes of fever and neutropenia in pediatric oncology: Is outpatient oral antibiotic therapy the new gold standard of care? Pediatr Blood Cancer. 2005 Sep;45(3):244-7. doi: 10.1002/pbc.20287. No abstract available.
Ammann RA, Bodmer N, Hirt A, Niggli FK, Nadal D, Simon A, Ozsahin H, Kontny U, Kuhne T, Popovic MB, Luthy AR, Aebi C. Predicting adverse events in children with fever and chemotherapy-induced neutropenia: the prospective multicenter SPOG 2003 FN study. J Clin Oncol. 2010 Apr 20;28(12):2008-14. doi: 10.1200/JCO.2009.25.8988. Epub 2010 Mar 15.
Brack E, Bodmer N, Simon A, Leibundgut K, Kuhne T, Niggli FK, Ammann RA. First-day step-down to oral outpatient treatment versus continued standard treatment in children with cancer and low-risk fever in neutropenia. A randomized controlled trial within the multicenter SPOG 2003 FN study. Pediatr Blood Cancer. 2012 Sep;59(3):423-30. doi: 10.1002/pbc.24076. Epub 2012 Jan 23.
Luthi F, Leibundgut K, Niggli FK, Nadal D, Aebi C, Bodmer N, Ammann RA. Serious medical complications in children with cancer and fever in chemotherapy-induced neutropenia: results of the prospective multicenter SPOG 2003 FN study. Pediatr Blood Cancer. 2012 Jul 15;59(1):90-5. doi: 10.1002/pbc.23277. Epub 2011 Aug 11.
Agyeman P, Aebi C, Hirt A, Niggli FK, Nadal D, Simon A, Ozsahin H, Kontny U, Kuhne T, Beck Popovic M, Leibundgut K, Bodmer N, Ammann RA. Predicting bacteremia in children with cancer and fever in chemotherapy-induced neutropenia: results of the prospective multicenter SPOG 2003 FN study. Pediatr Infect Dis J. 2011 Jul;30(7):e114-9. doi: 10.1097/INF.0b013e318215a290.
Ammann RA, Niggli FK, Leibundgut K, Teuffel O, Bodmer N. Exploring the association of hemoglobin level and adverse events in children with cancer presenting with fever in neutropenia. PLoS One. 2014 Jul 14;9(7):e101696. doi: 10.1371/journal.pone.0101696. eCollection 2014.
Agyeman P, Kontny U, Nadal D, Leibundgut K, Niggli F, Simon A, Kronenberg A, Frei R, Escobar H, Kuhne T, Beck-Popovic M, Bodmer N, Ammann RA. A prospective multicenter study of microbiologically defined infections in pediatric cancer patients with fever and neutropenia: Swiss Pediatric Oncology Group 2003 fever and neutropenia study. Pediatr Infect Dis J. 2014 Sep;33(9):e219-25. doi: 10.1097/INF.0000000000000326.
Ammann RA, Bodmer N, Simon A, Agyeman P, Leibundgut K, Schlapbach LJ, Niggli FK. Serum Concentrations of Mannan-Binding Lectin (MBL) and MBL-Associated Serine Protease-2 and the Risk of Adverse Events in Pediatric Patients With Cancer and Fever in Neutropenia. J Pediatric Infect Dis Soc. 2013 Jun;2(2):155-61. doi: 10.1093/jpids/pit005. Epub 2013 Feb 13.
Related Links
Access external resources that provide additional context or updates about the study.
The Swiss Pediatric Oncology Group (SPOG) was the sponsor of this study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Umbrella Network Trial 2004.3
Identifier Type: -
Identifier Source: secondary_id
OCS - 01466-02-2004
Identifier Type: -
Identifier Source: secondary_id
SPOG 2003 FN
Identifier Type: -
Identifier Source: org_study_id