FeverPhase 3NCT00107081
Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
A Phase 3 study testing ciprofloxacin and amoxicillin, Outpatient management and i.v. antibiotics in people with Fever and Neutropenia, run by Swiss Pediatric Oncology Group at 12 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Fever, Neutropenia, Cancer
- What is being tested?
- ciprofloxacin and amoxicillin, Outpatient management and i.v. antibiotics
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jan 2004to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Switzerland6 sites
Pediatric Hematology/Oncology, University Children's Hospital
Basel, CH-4005
Pediatric Hematology/Oncology, University Children's Hospital
Bern, CH-3010
Pediatric Hematology/Oncology, University Children's Hospital
Geneva, CH-1205
Pediatric Hematology/Oncology, University Children's Hospital
Lausanne, CH-1011
Pediatric Hematology/Oncology, Children's Hospital
Lucerne, CH-6004
Pediatric Hematology/Oncology, University Children's Hospital
Zurich, CH-8032
Germany5 sites
Pediatric Hematology/Oncology, University Children's Hospital
Bonn, D-53113
Pediatric Hematology/Oncology, University Children's Hospital
Düsseldorf, D-40225
Pediatric Hematology/Oncology, University Children's Hospital
Freiburg im Breisgau, D-79106
Pediatric Hematology/Oncology, University Children's Hospital von Hauner
Munich, D-80337
Pediatric Hematology/Oncology, University Hospital St. Hedwig
Regensburg, D-93049
Netherlands1 site
Pediatric Hematology/Oncology, University Children's Hospital
Groningen, NL-9700
About this study
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)
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.
Read the 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.
- Conditions
- Fever, Neutropenia, Cancer
- Being tested
- ciprofloxacin and amoxicillin, Outpatient management, i.v. antibiotics, inpatient management
- Keywords
- children, oral antibiotics, outpatient treatment, fever and neutropenia
- Medical subject headings
- Fever, Neutropenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacin and amoxicillinDrug
Outpatient managementProcedure or surgery
i.v. antibioticsDrug
inpatient managementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Continued inpatient i.v. antibiotics Receives: Drug: i.v. antibiotics; Procedure: inpatient management |
| Experimental | Experimental | Switch to outpatient p.o. antibiotics Receives: Drug: ciprofloxacin and amoxicillin; Procedure: Outpatient management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Efficacy: Response without rehospitalization or changing randomized antibiotics (non-inferiority design, limit 10%)
Secondary outcomes (3)
Improved prediction of low-risk episodes of fever and neutropenia
Description of characteristics of low-risk episodes of fever and neutropenia
Description of characteristics of high-risk episodes of fever and neutropenia (observational study part)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Accrual goal for interventional part not achievable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Pediatric Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cancer League, Bayer, GlaxoSmithKline
- Investigators
- Roland A Ammann, MD, Study chair, Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, SwitzerlandChristoph Aebi, MD, Study director, University Children's Hospital, Bern, SwitzerlandMaja Beck-Popovic, MD, Principal investigator, Pediatric Hematology/Oncology, University Children's Hospital, Lausanne, SwitzerlandEveline SJM de Bont, MD, Principal investigator, Pediatric Hematology/Oncology, University Children's Hospital, Groningen, The NetherlandsThomas Kuehne, MD, Principal investigator, Pediatric Hematology/Oncology, University Children's Hospital, Basel, SwitzerlandDavid Nadal, MD, Study director, University Children's Hospital, ZurichFelix Niggli, MD, Principal investigator, Pediatric Hematology/Oncology, University Children's Hospital, Zurich, SwitzerlandArne Simon, MD, Principal investigator, Pediatric Hematology/Oncology, University Children's Hospital, Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107081
- Sponsor's protocol ID
- SPOG 2003 FN
- Other IDs
- Umbrella Network Trial 2004.3, OCS - 01466-02-2004
- Status last verified
- Oct 2020
- First submitted
- 4 Apr 2005
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15747334Ammann 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.
PubMed 20231680Brack 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.
PubMed 22271702Luthi 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.
PubMed 21837771Agyeman 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.
PubMed 21394050Ammann 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.
PubMed 25020130Agyeman 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.
PubMed 24618935Ammann 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.
PubMed 26619462
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00107081
- Acronym / sponsor ID
- SPOG 2003 FN
- Conditions
- Fever, Neutropenia, Cancer
- Keywords
- children, oral antibiotics, outpatient treatment, fever and neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual goal for interventional part not achievable
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Swiss Pediatric Oncology GroupUniversity, hospital or other
- Collaborators
- Swiss Cancer League, Bayer, GlaxoSmithKline
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Drug: i.v. antibiotics, Procedure: inpatient managementContinued inpatient i.v. antibiotics |
| Experimental | Experimental | Drug: ciprofloxacin and amoxicillin, Procedure: Outpatient managementSwitch to outpatient p.o. antibiotics |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciprofloxacin and amoxicillin | Drug | Experimental |
| Outpatient management | Procedure or surgery | Experimental |
| i.v. antibiotics | Drug | Standard |
| inpatient management | Procedure or surgery | Standard |
Primary outcome
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%)
Efficacy: Response without rehospitalization or changing randomized antibiotics (non-inferiority design, limit 10%)
3 secondary outcomes
Improved prediction of low-risk episodes of fever and neutropenia
Description of characteristics of low-risk episodes of fever and neutropenia
Description of characteristics of high-risk episodes of fever and neutropenia (observational study part)
Results and safety
The study was stopped early (reason given: Accrual goal for interventional part not achievable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- BackgroundAmmann RA. SPOG 2003 FN: Risikobeurteilung und risikoadaptierte Behandlung bei Kindern und Jugendlichen mit Fieber in Neutropenie. Paediatrica 16(1): 28-31, 2005.
- Background: PubMed 15747334Ammann 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.
- Results publication: PubMed 20231680Ammann 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.
- Results publication: PubMed 22271702Brack 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.
- Results publication: PubMed 21837771Luthi 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.
- Results publication: PubMed 21394050Agyeman 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.
- Results publication: PubMed 25020130Ammann 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.
- Results publication: PubMed 24618935Agyeman 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.
- Results publication: PubMed 26619462Ammann 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.
- The Swiss Pediatric Oncology Group (SPOG) was the sponsor of this study.Link provided by the sponsor.
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland A Ammann, MD study chair
Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, Switzerland
Christoph Aebi, MD study director
University Children's Hospital, Bern, Switzerland
Maja Beck-Popovic, MD principal investigator
Pediatric Hematology/Oncology, University Children's Hospital, Lausanne, Switzerland
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ciprofloxacin and amoxicillin, Outpatient management and i.v. antibiotics in people with Fever and Neutropenia, run by Swiss Pediatric Oncology Group at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Accrual goal for interventional part not achievable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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%). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00107081, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.