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Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer

Primary Purpose

Chronic Myeloproliferative Disorders, Fever, Sweats, and Hot Flashes, Infection

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
amoxicillin-clavulanate potassium
ciprofloxacin
moxifloxacin hydrochloride
management of therapy complications
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Myeloproliferative Disorders focused on measuring 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, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia, adult acute myeloid leukemia in remission, polycythemia vera, primary myelofibrosis, essential thrombocythemia, progressive hairy cell leukemia, initial treatment, refractory hairy cell leukemia, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, chronic myelomonocytic leukemia, T-cell large granular lymphocyte leukemia, acute undifferentiated leukemia, stage III adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, prolymphocytic leukemia, primary systemic amyloidosis, intraocular lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, recurrent mantle cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, chronic eosinophilic leukemia, chronic neutrophilic leukemia, recurrent adult acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, contiguous stage II small lymphocytic lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Universitaire Erasme
  • Cliniques Universitaires Saint-Luc
  • U.Z. Gasthuisberg
  • Institut Bergonie
  • Institut Curie Hopital
  • Charite - Campus Charite Mitte
  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Medizinische Universitaetsklinik I at the University of Cologne
  • Klinikum der Albert - Ludwigs - Universitaet Freiburg
  • Ruprecht - Karls - Universitaet Heidelberg
  • Klinikum der Stadt Mannheim
  • Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt
  • Universitaetsklinikum Ulm
  • Wolfson Medical Center
  • Istituto Nazionale per la Ricerca sul Cancro
  • Universita Degli Studi di Udine
  • National Cancer Institute - Bratislava
  • St. Elizabeth Cancer Institute Hospital
  • Centre Hospitalier Universitaire Vaudois
  • Hopital D'Yverdon
  • Hacettepe University - Faculty of Medicine
  • Ibn-i Sina Hospital
  • Marmara University Hospital

Outcomes

Primary Outcome Measures

Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2003
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00062231
Brief Title
Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
April 2002 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloproliferative Disorders, Fever, Sweats, and Hot Flashes, Infection, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neutropenia, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific
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, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia, adult acute myeloid leukemia in remission, polycythemia vera, primary myelofibrosis, essential thrombocythemia, progressive hairy cell leukemia, initial treatment, refractory hairy cell leukemia, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, chronic myelomonocytic leukemia, T-cell large granular lymphocyte leukemia, acute undifferentiated leukemia, stage III adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, prolymphocytic leukemia, primary systemic amyloidosis, intraocular lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, recurrent mantle cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, chronic eosinophilic leukemia, chronic neutrophilic leukemia, recurrent adult acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, contiguous stage II small lymphocytic lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amoxicillin-clavulanate potassium
Intervention Type
Drug
Intervention Name(s)
ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
moxifloxacin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Primary Outcome Measure Information:
Title
Response as measured by International Antimicrobial Therapy Group (IATG) specific criteria at the completion of allocated treatment
Secondary Outcome Measure Information:
Title
Rate of complication as measured by Multinational Association for Supportive Care in Cancer (MASCC) criteria at the end of febrile neutropenic episode
Title
Time to discharge as measured by Logrank continuously until the end of febrile neutropenic episode
Title
Time to defervescence as measured by Logrank continuously until the end of febrile neutropenic episode
Title
Survival status as measured by Logrank at day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Kern, MD
Organizational Affiliation
University Hospital Freiburg
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Charite - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Klinikum der Albert - Ludwigs - Universitaet Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Ruprecht - Karls - Universitaet Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69117
Country
Germany
Facility Name
Klinikum der Stadt Mannheim
City
Mannheim
ZIP/Postal Code
D-68135
Country
Germany
Facility Name
Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt
City
Rostock
ZIP/Postal Code
D-18057
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Universita Degli Studi di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
National Cancer Institute - Bratislava
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
St. Elizabeth Cancer Institute Hospital
City
Bratislava
ZIP/Postal Code
SK-81250
Country
Slovakia
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Hopital D'Yverdon
City
Yverdon
ZIP/Postal Code
CH-1400
Country
Switzerland
Facility Name
Hacettepe University - Faculty of Medicine
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ibn-i Sina Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
81190
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
23358983
Citation
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.
Results Reference
derived

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Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer

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