Chronic Myeloproliferative DisordersNCT00062231
Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
A study testing amoxicillin-clavulanate potassium, ciprofloxacin and moxifloxacin hydrochloride in people with Chronic Myeloproliferative Disorders and Fever, Sweats, and Hot Flashes, run by European Organisation for Research and Treatment of Cancer - EORTC at 23 sites in 8 countries.
Trial summary
RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Fever, Sweats, and Hot Flashes, Infection
- What is being tested?
- amoxicillin-clavulanate potassium, ciprofloxacin and moxifloxacin hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 351 participants
- Where
- 23 sitesin 8 countries
- Study dates
- Apr 2002to Oct 2006
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of cancer with developing febrile neutropenia
- Neutropenia defined as an absolute granulocyte count of less than 1,000/mm^3, expected to fall to less than 500/mm^3 within 24 hours, secondary to administration of chemotherapy and/or radiotherapy within the past 30 days
- Fever defined as an oral temperature greater than 38.5ºC once, or 38°C or greater on 2 or more occasions at least 1 hour apart during a 12-hour period, and suspected to be due to infection
- Expected low risk of serious medical complications as predicted by a Multinational Association for Supportive Care in Cancer risk-index score of greater than 20
- No obvious signs of exit-site or tunnel intravascular catheter infection
- No known or suspected CNS infection
- No known or highly suspected bacterial, viral, or fungal infection
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- No high probability of death within 48 hours before study enrollment (i.e., patients who are moribund or comatose for any reason with little hope of recovery OR patients in danger of, or in hepatic stupor or coma)
Hematopoietic
- See Disease Characteristics
- No signs or symptoms of uncontrolled bleeding
Hepatic
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 3 times ULN
- AST and ALT no greater than 5 times ULN
- No severe hepatic dysfunction
Renal
- Creatinine no greater than 3.4 mg/dL
- Creatinine clearance at least 25 mL/min
- No renal failure requiring hemodialysis or peritoneal dialysis
Cardiovascular
- No prior symptomatic arrhythmias
- No clinically relevant bradycardia
- No QTc interval prolongation
- No uncorrected hypokalemia
- No signs or symptoms of hypotension (systolic less than 90 mm Hg)
Pulmonary
- No signs or symptoms of respiratory insufficiency
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to swallow oral medication
- No contraindication for oral drug intake
- No condition likely to severely impair drug absorption
- No prior immediate or accelerated reaction to penicillin, cephalosporin, or fluoroquinolone antibiotics
- No known allergy or hypersensitivity to any antibiotics in this study or other quinolones
- No signs or symptoms of severe dehydration
- No signs or symptoms of shock
- No other signs or symptoms at presentation that would necessitate IV supportive therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- More than 4 days since prior antibacterial agents except for the following:
- A single (oral or parenteral therapeutic) dose after initial diagnosic work-up and within the last 8 hours
- Low-dose cotrimoxazole (i.e., no more than 480 mg daily or 960 mg 3 times per week) prophylaxis of Pneumocystis carinii pneumonia
- More than 30 days since prior investigational drugs
- No prior randomization in this study
- No other concurrent antimicrobial agents
- No class IA or class III antiarrhythmic drugs or other concurrent drugs that prolong the QTc interval
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Germany8 sites
Charite - Campus Charite Mitte
Berlin, D-10117
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924
Klinikum der Albert - Ludwigs - Universitaet Freiburg
Freiburg im Breisgau, D-79106
Ruprecht - Karls - Universitaet Heidelberg
Heidelberg, D-69117
Klinikum der Stadt Mannheim
Mannheim, D-68135
Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt
Rostock, D-18057
Universitaetsklinikum Ulm
Ulm, D-89081
Belgium3 sites
Hopital Universitaire Erasme
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
U.Z. Gasthuisberg
Leuven, B-3000
Turkey (Türkiye)3 sites
Hacettepe University - Faculty of Medicine
Ankara, 06100
Ibn-i Sina Hospital
Ankara, 06100
Marmara University Hospital
Istanbul, 81190
France2 sites
Institut Bergonie
Bordeaux, 33076
Institut Curie Hopital
Paris, 75248
Italy2 sites
Istituto Nazionale per la Ricerca sul Cancro
Genoa, 16132
Universita Degli Studi di Udine
Udine, 33100
Slovakia2 sites
National Cancer Institute - Bratislava
Bratislava, 833 10
St. Elizabeth Cancer Institute Hospital
Bratislava, SK-81250
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Hopital D'Yverdon
Yverdon-les-Bains, CH-1400
About this study
Official title: Oral Empirical Therapy of Fever in Low-Risk Neutropenic Cancer Patients: A Prospective, Double-Blind, Randomized, Multicenter Trial Comparing Monotherapy (Single Daily Dose Moxifloxacin) With Combination Therapy (Ciprofloxacin Plus Amoxicillin/Clavulanic Acid)
RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever.
PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.
Read the detailed description
OBJECTIVES:
- Compare the rates of successful response to moxifloxacin vs ciprofloxacin in combination with amoxicillin-clavulanate potassium in low-risk febrile neutropenic patients with cancer.
- Compare the time to discharge, time to discontinuation of any antimicrobial therapy, and time to defervescence of patients treated with these regimens.
- Compare 28-day survival of patients treated with these regimens.
- Determine the proportion of these patients who are eligible for oral therapy and a therapeutic management including intention of early discharge.
- Determine the medical and nonmedical reasons for continued in-hospital observation and care or for readmission of these patients.
- Determine the accuracy of the physician's estimate of further neutropenia duration and evaluate its predictive value in these patients.
- Validate the Multinational Association for Supportive Care in Cancer low-risk prediction rule to predict the absence of serious medical complications in the setting of oral therapy in in- and outpatients.
OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to institution, underlying disease (hematologic malignancy vs other), pretreatment with no more than a single dose (yes vs no), and outpatient status at fever onset (yes vs no). Patients are randomized into 1 of 2 treatment arms.
- Arm I: Patients receive oral moxifloxacin once daily. Patients also receive oral ciprofloxacin placebo and oral amoxicillin-clavulanate potassium placebo twice daily.
- Arm II: Patients receive oral ciprofloxacin and oral amoxicillin-clavulanate potassium twice daily. Patients also receive oral moxifloxacin placebo once daily.
Patients with fever classified as not related to infection (i.e., doubtful) stop antibiotic therapy on day 3. All other patients receive antibiotics until complete resolution of infection, or until failure is determined or anticipated, for up to 28 days.
Patients are followed at 7-10 days.
PROJECTED ACCRUAL: A total of 530 patients (265 patients per treatment arm) will be accrued for this study within approximately 2 years.
- Conditions
- Chronic Myeloproliferative Disorders, Fever, Sweats, and Hot Flashes, Infection, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Being tested
- amoxicillin-clavulanate potassium, ciprofloxacin, moxifloxacin hydrochloride, management of therapy complications
- Keywords
- infection, neutropenia, fever, sweats, and hot flashes, unspecified adult solid tumor, protocol specific, stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, monoclonal gammopathy of undetermined significance, recurrent adult Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, isolated plasmacytoma of bone, extramedullary plasmacytoma, refractory multiple myeloma, stage 0 chronic lymphocytic leukemia, Waldenstrom macroglobulinemia
- Medical subject headings
- Myeloproliferative Disorders, Fever, Hot Flashes, Infections, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amoxicillin-clavulanate potassiumDrug
ciprofloxacinDrug
moxifloxacin hydrochlorideDrug
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
Secondary outcomes (4)
Rate of complication as measured by Multinational Association for Supportive Care in Cancer (MASCC) criteria at the end of febrile neutropenic episode
Time to discharge as measured by Logrank continuously until the end of febrile neutropenic episode
Time to defervescence as measured by Logrank continuously until the end of febrile neutropenic episode
Survival status as measured by Logrank at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startApr 2002
- Primary completionOct 2006
Why it stopped: low accrual
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 Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Winfried Kern, MD, Study chair, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062231
- Sponsor's protocol ID
- EORTC-46001
- Other IDs
- EORTC-46001
- Status last verified
- Sep 2012
- First submitted
- 5 Jun 2003
- Last updated
- 24 Sep 2012
- Results posted
- No
Publications
Kern WV, Marchetti O, Drgona L, Akan H, Aoun M, Akova M, de Bock R, Paesmans M, Viscoli C, Calandra T. Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV. J Clin Oncol. 2013 Mar 20;31(9):1149-56. doi: 10.1200/JCO.2012.45.8109. Epub 2013 Jan 28.
PubMed 23358983
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Empirical Therapy of Fever in Low-Risk Neutropenic Cancer Patients: A Prospective, Double-Blind, Randomized, Multicenter Trial Comparing Monotherapy (Single Daily Dose Moxifloxacin) With Combination Therapy (Ciprofloxacin Plus Amoxicillin/Clavulanic Acid)
- ClinicalTrials.gov ID
- NCT00062231
- Acronym / sponsor ID
- EORTC-46001
- Conditions
- Chronic Myeloproliferative Disorders, Fever, Sweats, and Hot Flashes, Infection, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- infection, neutropenia, fever, sweats, and hot flashes, unspecified adult solid tumor, protocol specific, stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 351 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 2002
- Primary completion
- Oct 2006 (actual)
- First posted
- 6 Jun 2003 (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.
RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever.
PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.
Detailed description
OBJECTIVES:
- Compare the rates of successful response to moxifloxacin vs ciprofloxacin in combination with amoxicillin-clavulanate potassium in low-risk febrile neutropenic patients with cancer.
- Compare the time to discharge, time to discontinuation of any antimicrobial therapy, and time to defervescence of patients treated with these regimens.
- Compare 28-day survival of patients treated with these regimens.
- Determine the proportion of these patients who are eligible for oral therapy and a therapeutic management including intention of early discharge.
- Determine the medical and nonmedical reasons for continued in-hospital observation and care or for readmission of these patients.
- Determine the accuracy of the physician's estimate of further neutropenia duration and evaluate its predictive value in these patients.
- Validate the Multinational Association for Supportive Care in Cancer low-risk prediction rule to predict the absence of serious medical complications in the setting of oral therapy in in- and outpatients.
OUTLINE: This is a double-blind, randomized, multicenter study. Patients are stratified according to institution, underlying disease (hematologic malignancy vs other), pretreatment with no more than a single dose (yes vs no), and outpatient status at fever onset (yes vs no). Patients are randomized into 1 of 2 treatment arms.
- Arm I: Patients receive oral moxifloxacin once daily. Patients also receive oral ciprofloxacin placebo and oral amoxicillin-clavulanate potassium placebo twice daily.
- Arm II: Patients receive oral ciprofloxacin and oral amoxicillin-clavulanate potassium twice daily. Patients also receive oral moxifloxacin placebo once daily.
Patients with fever classified as not related to infection (i.e., doubtful) stop antibiotic therapy on day 3. All other patients receive antibiotics until complete resolution of infection, or until failure is determined or anticipated, for up to 28 days.
Patients are followed at 7-10 days.
PROJECTED ACCRUAL: A total of 530 patients (265 patients per treatment arm) will be accrued for this study within approximately 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| amoxicillin-clavulanate potassium | Drug | – |
| ciprofloxacin | Drug | – |
| moxifloxacin hydrochloride | Drug | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
4 secondary outcomes
Rate of complication as measured by Multinational Association for Supportive Care in Cancer (MASCC) criteria at the end of febrile neutropenic episode
Time to discharge as measured by Logrank continuously until the end of febrile neutropenic episode
Time to defervescence as measured by Logrank continuously until the end of febrile neutropenic episode
Survival status as measured by Logrank at day 28
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
- Derived from this study: PubMed 23358983Kern WV, Marchetti O, Drgona L, Akan H, Aoun M, Akova M, de Bock R, Paesmans M, Viscoli C, Calandra T. Oral antibiotics for fever in low-risk neutropenic patients with cancer: a double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy--EORTC infectious diseases group trial XV. J Clin Oncol. 2013 Mar 20;31(9):1149-56. doi: 10.1200/JCO.2012.45.8109. Epub 2013 Jan 28.
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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.
Winfried Kern, MD study chair
University Hospital Freiburg
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amoxicillin-clavulanate potassium, ciprofloxacin and moxifloxacin hydrochloride in people with Chronic Myeloproliferative Disorders and Fever, Sweats, and Hot Flashes, run by European Organisation for Research and Treatment of Cancer - EORTC at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Belgium, Turkey (Türkiye), France, Italy and 3 more countries. 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.
Are results available for this study?
The study was stopped early (reason given: low accrual). 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?
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment. 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 NCT00062231, 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 24 Sep 2012.