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Ciprofloxacin and levofloxacin are both in guidelines to use for prophylaxis in autologous and allogeneic Stem cell transplant.Ciprofloxacin was recently replaced by levofloxacin as the preferred agent in some transplant centers. In some small retrospective studies ciprofloxacin prophylaxis was associated with a higher rate of breakthrough gram positive bloodstream infections. However, the optimum oral agent for antibacterial prophylaxis in transplant recipients remains uncertain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levo | Experimental | Levofloxacin 500 mg once daily |
|
| Cipro | Active Comparator | Ciprofloxacin 500 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Bloodstream Bacterial Infections | to assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant | 60 days post stem cell transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39019103 | Result | Farhan S, Mazur I, Hartzell S, Xie P, Neme K, German A, Mikulandric N, Patel K, Wu M, Kortam N, Yaseen A, Sweidan A, Latack K, Emole J, Peres E, Abidi MH, Ramesh M. Ciprofloxacin versus levofloxacin prophylaxis in hematopoietic stem cell transplantation: A randomized trial. Int J Infect Dis. 2024 Oct;147:107172. doi: 10.1016/j.ijid.2024.107172. Epub 2024 Jul 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levo | Levofloxacin 500 mg once daily Levofloxacin: This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment |
| FG001 | Cipro | Ciprofloxacin 500 mg BID Ciprofloxacin: This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levo | Levofloxacin 500 mg once daily Levofloxacin: This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment |
| BG001 | Cipro |
| 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 | Proportion of Bloodstream Bacterial Infections | to assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant | Posted | Number | participants | 60 days post stem cell transplant |
|
2 months
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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 | Levo | Levofloxacin 500 mg once daily Levofloxacin: This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arrythmias | Cardiac disorders | Systematic Assessment |
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Our study has several limitations that need to be considered when interpreting the results. First, the study was randomized but open-label. This could have influenced decisions about patient care, potentially biasing the results. Second, the study only documented infections until day 60, which might not capture resistant bacterial infections that may occur later. Third, this study unfortunately lacks information on the gut microbiome, which might play a role in the observed outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shatha Farhan | Henry Ford Health | 3137133910 | sfarhan1@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2018 | Oct 1, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| Ciprofloxacin | Drug | This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000 |
|
Ciprofloxacin 500 mg BID Ciprofloxacin: This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 42 |
| 154 |
| 23 |
| 154 |
| 0 |
| 154 |
| EG001 | Cipro | Ciprofloxacin 500 mg BID Ciprofloxacin: This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment | 54 | 154 | 20 | 154 | 0 | 154 |
| fluid overload | Cardiac disorders | Systematic Assessment |
|
| encephalopathy | Nervous system disorders | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| syncope | Cardiac disorders | Systematic Assessment |
|
| CMV viremia | Infections and infestations | Systematic Assessment |
|
| hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| thrombotic microangiopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| airway obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |