Febrile NeutropeniaPhase 3NCT00137787
Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
A Phase 3 study testing ciprofloxacin and cefepime in people with Febrile Neutropenia, run by Center for Supporting Hematology-Oncology Trials at 1 site in Japan.
Trial summary
The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases. Read more about this study
- Who is it for?
- Ages 15 to 79 years
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- ciprofloxacin and cefepime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2005to May 2010
- 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 15 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hematologic disease
- Ages between 15 and 79 years
- Axillary temperature of 38.0 C or greater on one occasion or of 37.5 to 37.9 C lasting for more than 1 hour
- Absolute neutrophil count of less than 500/microL
- T-Bil level less than 2.0 times the upper limit of normal
- Cre level less than 1.5 times the upper limit of normal
- Written informed consent
Who cannot join
- Past history of allergic reaction to the study drug
- Positive for HIV antibody
- Pregnant or lactating women
- Family history of auditory disturbance
- Having received systemic antibacterial therapy within 14 days
- Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation
Show all 10Show fewer
- No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode
- On treatment with ketoprofen
- On treatment with sodium valproate
- Septic shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.
Read the detailed description
Infectious complications during neutropenic periods are major causes of morbidity and mortality especially for patients with hematological diseases, and prompt initiation of antibiotic therapy is warranted for those who develop febrile neutropenia. As for initial therapeutic agents, beta-lactam antibiotics, i.e., third- or fourth-generation cephalosporins and carbapenems have been used frequently because of their strong and broad-spectrum of action. However, under these conditions, development of resistance mediated by a beta-lactamase is concerned, and there is a need for alternative non-beta-lactam antibiotics for this indication. Ciprofloxacin is a potent agent covering against wide range of strains including Pseudomonas aeruginosa, and expected as a potential candidate. We have therefore planned a prospective randomized controlled trial designed to compare intravenous ciprofloxacin with cefepime for febrile neutropenic patients.
- Conditions
- Febrile Neutropenia
- Being tested
- ciprofloxacin, cefepime
- Keywords
- febrile neutropenia, hematologic disease
- Medical subject headings
- Febrile Neutropenia, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacinDrug
cefepimeDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ciprofloxacin |
| 2 | Active comparator | Not described Receives: Drug: cefepime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Measured: At 7 days after initiating therapy
Secondary outcomes (2)
Treatment efficacy
Measured: At 21 days
Toxicity
Measured: During the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Febrile NeutropeniaStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Supporting Hematology-Oncology Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Yoshiko Atsuta, MD, Study director, Nagoya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137787
- Sponsor's protocol ID
- C-SHOT 0402
- Status last verified
- Jun 2018
- First submitted
- 28 Aug 2005
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.
PubMed 23317527
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases
- ClinicalTrials.gov ID
- NCT00137787
- Acronym / sponsor ID
- C-SHOT 0402
- Conditions
- Febrile Neutropenia
- Keywords
- febrile neutropenia, hematologic disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Center for Supporting Hematology-Oncology TrialsUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2005 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Aug 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 aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.
Detailed description
Infectious complications during neutropenic periods are major causes of morbidity and mortality especially for patients with hematological diseases, and prompt initiation of antibiotic therapy is warranted for those who develop febrile neutropenia. As for initial therapeutic agents, beta-lactam antibiotics, i.e., third- or fourth-generation cephalosporins and carbapenems have been used frequently because of their strong and broad-spectrum of action. However, under these conditions, development of resistance mediated by a beta-lactamase is concerned, and there is a need for alternative non-beta-lactam antibiotics for this indication. Ciprofloxacin is a potent agent covering against wide range of strains including Pseudomonas aeruginosa, and expected as a potential candidate. We have therefore planned a prospective randomized controlled trial designed to compare intravenous ciprofloxacin with cefepime for febrile neutropenic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ciprofloxacin |
| 2 | Active comparator | Drug: cefepime |
Who may qualify
- Ages
- 15 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Hematologic disease
- Ages between 15 and 79 years
- Axillary temperature of 38.0 C or greater on one occasion or of 37.5 to 37.9 C lasting for more than 1 hour
- Absolute neutrophil count of less than 500/microL
- T-Bil level less than 2.0 times the upper limit of normal
Key exclusion criteria (10 listed)
- Past history of allergic reaction to the study drug
- Positive for HIV antibody
- Pregnant or lactating women
- Family history of auditory disturbance
- Having received systemic antibacterial therapy within 14 days
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 | Drug | 1 |
| cefepime | Drug | 2 |
Primary outcome
Treatment efficacy
Time frame: At 7 days after initiating therapy
2 secondary outcomes
Treatment efficacy
Time frame: At 21 days
Toxicity
Time frame: During the follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Results publication: PubMed 23317527Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.
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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.
Yoshiko Atsuta, MD study director
Nagoya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ciprofloxacin and cefepime in people with Febrile Neutropenia, run by Center for Supporting Hematology-Oncology Trials at 1 site in Japan.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment efficacy (time frame: At 7 days after initiating therapy). 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 NCT00137787, which also lists 1 linked publication.
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 26 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.