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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003271-21 | EudraCT Number |
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This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.
Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.
Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Experimental | moxifloxacin 400 mg tablets once daily |
|
| Placebo | Placebo Comparator | identical appearing placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin | Drug | 400 mg p.o. per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Clinically Significant Bacteremia | Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary. With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant. | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Isolates and Infections | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) | |
| Time to Occurrence of Fever >= 38°C | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver A. Cornely, MD | Universität zu Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der Universität zu Köln | Cologne | 50924 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22169408 | Result | Vehreschild JJ, Moritz G, Vehreschild MJ, Arenz D, Mahne M, Bredenfeld H, Chemnitz J, Klein F, Cremer B, Boll B, Kaul I, Wassmer G, Hallek M, Scheid C, Cornely OA. Efficacy and safety of moxifloxacin as antibacterial prophylaxis for patients receiving autologous haematopoietic stem cell transplantation: a randomised trial. Int J Antimicrob Agents. 2012 Feb;39(2):130-4. doi: 10.1016/j.ijantimicag.2011.10.009. Epub 2011 Dec 12. |
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68 patients were intended for inclusion in the trial. Two patients were excluded due to violation of inclusion/exclusion criteria; both received no study drug and they were excluded from the analysis. The remaining 66 participants were evaluable for response analysis in the intention to treat (ITT) set.
First patient in: Oct 10, 2006; Last patient, last visit: Dec 08, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin | moxifloxacin 400 mg tablets once daily |
| FG001 | Placebo | identical appearing placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin | moxifloxacin 400 mg tablets once daily |
| BG001 | Placebo | identical appearing placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Clinically Significant Bacteremia | Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary. With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant. | intention to treat (ITT) | Posted | Number | participants | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) |
|
Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
The following AE have been documented in the trial but are not reported in this section unless as SAE:
Infections, already reported as outcome measures.
Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moxifloxacin | moxifloxacin 400 mg tablets once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atypical pneumonia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal cramps | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Oliver A. Cornely | University of Cologne | +49 221 478 88794 | oliver.cornely@zks-koeln.de |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| placebo | Drug | one tablet per day p.o. |
|
|
| Reason for Discontinuation of Treatment | Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) |
| Type of Infection | follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) |
| Overall Survival | follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Underlying Disease | Number | participants |
|
| Status of Underlying Disease | Number | participants |
|
|
|
| Secondary | Type of Isolates and Infections | intention to treat (ITT) | Posted | Number | participants | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) |
|
|
|
| Secondary | Time to Occurrence of Fever >= 38°C | intention to treat (ITT) | Posted | Mean | Standard Deviation | days | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) |
|
|
|
| Secondary | Reason for Discontinuation of Treatment | Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason | intention to treat (ITT) | Posted | Number | participants | end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm) |
|
|
|
| Secondary | Type of Infection | intention to treat (ITT) | Posted | Number | participants | follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) |
|
|
|
| Secondary | Overall Survival | intention to treat (ITT) | Posted | Number | participants | follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) |
|
|
|
| 2 |
| 34 |
| 34 |
| 34 |
| EG001 | Placebo | identical appearing placebo | 3 | 32 | 32 | 32 |
| cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| clostridium difficile infection | Infections and infestations | Systematic Assessment |
|
| staphyloccocus epidermidis sepsis | Infections and infestations | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cramps in the calf | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| edema | General disorders | Non-systematic Assessment |
|
| exanthema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| fever | Infections and infestations | Systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| heartburn / reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Systematic Assessment |
|
| hypokalemia | General disorders | Systematic Assessment |
|
| hyponatremia | General disorders | Systematic Assessment |
|
| hypotension | Vascular disorders | Systematic Assessment |
|
| increase of CRP | Blood and lymphatic system disorders | Systematic Assessment |
|
| increase of bilirubin | Hepatobiliary disorders | Systematic Assessment |
|
| increase of creatinine | Renal and urinary disorders | Systematic Assessment |
|
| increase of liver enzymes | Hepatobiliary disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| bacteremia isolate: klebsiella pneumoniae |
|
| bacteremia isolate: pseudomonas aeruginosa |
|
| bacteremia isolate: staphylococcus aureus |
|
| bacteremia isolate: staphylococcus epidermidis |
|
| bacteremia isolate: streptococcus species |
|
| clostridium difficile infection |
|
| mucositis |
|
| premature discontinuation: occurence of fever |
|
| premature discontinuation: antibiotic treatment |
|
| premature discontinuation: death |
|
| premature discontinuation: other adverse event |
|
| premature discontinuation: other reason |
|
| pulmonary infiltrate |
|
| infection at venous catheter |
|
| herpes infection |
|
| candida infection |
|
| acute respiratory syndrome |
|
| clostridium difficile infection |
|
| atypical pneumonia |
|