Trial Outcomes & Findings for Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant (NCT NCT03850379)
NCT ID: NCT03850379
Last Updated: 2025-10-17
Results Overview
to assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
308 participants
Primary outcome timeframe
60 days post stem cell transplant
Results posted on
2025-10-17
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
154
|
|
Overall Study
COMPLETED
|
154
|
154
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Levo
n=154 Participants
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
|
Cipro
n=154 Participants
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
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
62 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
93 participants
n=99 Participants
|
100 participants
n=107 Participants
|
193 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African Americans
|
50 participants
n=99 Participants
|
41 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Others
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=99 Participants
|
154 participants
n=107 Participants
|
308 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 60 days post stem cell transplantto assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant
Outcome measures
| Measure |
Levo
n=154 Participants
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 defined as ANC \>1000
|
Cipro
n=154 Participants
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 defined as ANC \>1000
|
|---|---|---|
|
Proportion of Bloodstream Bacterial Infections
|
18 participants
|
18 participants
|
Adverse Events
Levo
Serious events: 23 serious events
Other events: 0 other events
Deaths: 42 deaths
Cipro
Serious events: 20 serious events
Other events: 0 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Levo
n=154 participants at risk
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
|
Cipro
n=154 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
arrythmias
|
10.4%
16/154 • 2 months
|
7.8%
12/154 • 2 months
|
|
Cardiac disorders
fluid overload
|
1.9%
3/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Nervous system disorders
encephalopathy
|
1.3%
2/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Nervous system disorders
seizure
|
0.00%
0/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Gastrointestinal disorders
bowel obstruction
|
0.00%
0/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Cardiac disorders
syncope
|
0.00%
0/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Infections and infestations
CMV viremia
|
0.00%
0/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Blood and lymphatic system disorders
hematoma
|
0.00%
0/154 • 2 months
|
0.65%
1/154 • 2 months
|
|
Blood and lymphatic system disorders
thrombotic microangiopathy
|
0.65%
1/154 • 2 months
|
0.00%
0/154 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
airway obstruction
|
0.65%
1/154 • 2 months
|
0.00%
0/154 • 2 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place