Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00107081
Other study ID # SPOG 2003 FN
Secondary ID Umbrella Network
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 2004
Est. completion date December 2007

Study information

Verified date October 2020
Source Swiss Pediatric Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 70
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ciprofloxacin and amoxicillin

Procedure:
Outpatient management

Drug:
i.v. antibiotics

Procedure:
inpatient management


Locations

Country Name City State
Germany 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
Netherlands Pediatric Hematology/Oncology, University Children's Hospital Groningen
Switzerland 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

Sponsors (4)

Lead Sponsor Collaborator
Swiss Pediatric Oncology Group Bayer, GlaxoSmithKline, Swiss Cancer League

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland, 

References & Publications (9)

Agyeman P, Aebi C, Hirt A, Niggli FK, Nadal D, Simon A, Ozsahin H, Kontny U, Kühne 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 prospectiv — View Citation

Agyeman P, Kontny U, Nadal D, Leibundgut K, Niggli F, Simon A, Kronenberg A, Frei R, Escobar H, Kühne T, Beck-Popovic M, Bodmer N, Ammann RA. A prospective multicenter study of microbiologically defined infections in pediatric cancer patients with fever a — View Citation

Ammann RA, Bodmer N, Hirt A, Niggli FK, Nadal D, Simon A, Ozsahin H, Kontny U, Kühne T, Popovic MB, Lüthy AR, Aebi C. Predicting adverse events in children with fever and chemotherapy-induced neutropenia: the prospective multicenter SPOG 2003 FN study. J — View Citation

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 Neutrop — View Citation

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. — View Citation

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. — View Citation

Ammann RA. SPOG 2003 FN: Risikobeurteilung und risikoadaptierte Behandlung bei Kindern und Jugendlichen mit Fieber in Neutropenie. Paediatrica 16(1): 28-31, 2005.

Brack E, Bodmer N, Simon A, Leibundgut K, Kühne 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 t — View Citation

Lüthi 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. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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%)
Primary Efficacy: Response without rehospitalization or changing randomized antibiotics (non-inferiority design, limit 10%)
Secondary Improved prediction of low-risk episodes of fever and neutropenia
Secondary Description of characteristics of low-risk episodes of fever and neutropenia
Secondary Description of characteristics of high-risk episodes of fever and neutropenia (observational study part)
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients