Prophylaxis, Stem Cell Transplant Complications
Conditions
Brief summary
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.
Interventions
DRUGLevofloxacin
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
DRUGCiprofloxacin
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
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18-75 years of age with a diagnosis of a hematological malignancy. Meet the stem cell transplant program criteria to undergo autologous or allogeneic hematopoietic stem cell transplantation.
Exclusion criteria
* Prolonged QT * Allergies to ciprofloxacin or levofloxacin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Bloodstream Bacterial Infections | 60 days post stem cell transplant | to assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 154 |
| 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 | 154 |
| Total | 308 |
Baseline characteristics
| Characteristic | Levo | Cipro | Total |
|---|---|---|---|
| Age, Continuous | 63 years | 62 years | 63 years |
| Race/Ethnicity, Customized African Americans | 50 participants | 41 participants | 91 participants |
| Race/Ethnicity, Customized Caucasian | 93 participants | 100 participants | 193 participants |
| Race/Ethnicity, Customized Others | 11 participants | 13 participants | 24 participants |
| Region of Enrollment United States | 154 participants | 154 participants | 308 participants |
| Sex: Female, Male Female | 70 Participants | 66 Participants | 136 Participants |
| Sex: Female, Male Male | 84 Participants | 88 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 42 / 154 | 54 / 154 |
| other Total, other adverse events | 0 / 154 | 0 / 154 |
| serious Total, serious adverse events | 23 / 154 | 20 / 154 |
Outcome results
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
Time frame: 60 days post stem cell transplant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levo | Proportion of Bloodstream Bacterial Infections | 18 participants |
| Cipro | Proportion of Bloodstream Bacterial Infections | 18 participants |