Trial Outcomes & Findings for Ciprofloxacin for Prevention of BK Infection (NCT NCT01789203)

Last Updated: 2019-11-13

Results Overview

Number of patients (followed by proportion) developing BK infection at 6 months post-transplant. BK infection is defined as the presence of a detectable BK viral load in plasma by polymerase chain reaction (PCR), or the presence of BK viral inclusions on kidney biopsy specimens.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

6 months

Results posted on

2019-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Ciprofloxacin Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Overall Study STARTED	133	67
Overall Study COMPLETED	124	63
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Ciprofloxacin Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	1	0
Overall Study Death	1	0
Overall Study Protocol Violation	2	1
Overall Study Other	1	1
Overall Study patient non-adherent	2	0

Baseline Characteristics

Ciprofloxacin for Prevention of BK Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo	Total n=200 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	44 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	20 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	47 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized Asian	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	32 Participants n=5 Participants	14 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized White	57 Participants n=5 Participants	28 Participants n=7 Participants	85 Participants n=5 Participants
Race/Ethnicity, Customized Other or Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Repeat Transplant	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Number of Patients Developing BK Infection at 6 Months Post-transplant	25 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 months

Number of patients with gram negative urinary tract infections as defined by a midstream urine sample containing 10\^4 or more colony-forming units per mL

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Number of Patients With Gram Negative Urinary Tract Infections at 6 Months	17 Participants	14 Participants

SECONDARY outcome

Timeframe: 6 months

Number of patients with bacteremic infection at 6 months. Bacteremia defined by a single positive blood culture that was not thought to be contaminated.

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Number of Patients With Bacteremia at 6 Months	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

Number of patients with quinolone-resistant gram negative bacterial infections, among those with a gram-negative infection

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=18 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=14 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Number of Patients With Quinolone-resistant Infection at 6 Months	15 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months

Clostridium difficile infection at 6 months

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Clostridium Difficile at 6 Months	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 months

Serious adverse events collected for up to 4 months (3 months on study drug plus 1 additional month)

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Serious Adverse Events	35 Participants	18 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Included 31 ciprofloxacin and 8 placebo patients who became BK viremic during the first 12 months

Median time to initial BK viremia episode, days

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=31 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=8 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Time to BK Infection	90 days Interval 59.0 to 160.0	76.5 days Interval 59.0 to 295.0

SECONDARY outcome

Timeframe: 12 months

Proportion of patients developing BK viremia at 1 year

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
BK Viremia at 1 Year	31 Participants	8 Participants

SECONDARY outcome

Timeframe: 12 months

Population: included 31 ciprofloxacin and 8 placebo patients who became BK viremic during the first year

First BK plasma viral loads

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=31 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=8 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
First Plasma Viral Loads	2514 copies/mL Interval 796.0 to 8754.0	1423 copies/mL Interval 724.0 to 19619.0

SECONDARY outcome

Timeframe: 12 months

Number of patients with biopsy-proven acute rejection of the allograft at 1 year, based on Banff classification

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Acute Rejection at 1 Year	14 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

kidney failure within first 1 year of transplant

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Graft Loss at 1 Year	14 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Patient death at 1 year

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=133 Participants Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 Participants Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Death at 1 Year	1 Participants	1 Participants

Adverse Events

Ciprofloxacin

Serious events: 35 serious events

Other events: 108 other events

Deaths: 1 deaths

Placebo

Serious events: 18 serious events

Other events: 55 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ciprofloxacin n=133 participants at risk Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant Ciprofloxacin: Patients will be randomized 2:1 active comparator to placebo comparator.	Placebo n=67 participants at risk Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant placebo
Gastrointestinal disorders Constipation	9.0% 12/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	4.5% 3/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Gastrointestinal disorders Diarrhea	8.3% 11/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	10.4% 7/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Gastrointestinal disorders Dyspepsia	8.3% 11/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	9.0% 6/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
General disorders Edema	11.3% 15/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	19.4% 13/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
General disorders Headache	5.3% 7/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	1.5% 1/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Renal and urinary disorders Hematuria	1.5% 2/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	6.0% 4/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
General disorders Hypomagnesemia	6.0% 8/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	0.00% 0/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
General disorders Insomnia	6.0% 8/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	4.5% 3/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Gastrointestinal disorders Nausea	5.3% 7/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	7.5% 5/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Musculoskeletal and connective tissue disorders Osteopenia/osteoperosis	14.3% 19/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	10.4% 7/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Renal and urinary disorders Proteinuria	9.0% 12/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	6.0% 4/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
Infections and infestations Urinary tract infections	13.5% 18/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	22.4% 15/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year
General disorders Weight gain	5.3% 7/133 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year	9.0% 6/67 • Adverse events were collected out through 4 months (3 months of study drug administration + 1 month post- administration). Patients were asked during clinic visits to report any potential ciprofloxacin adverse event from a list of common adverse effects. Additional AEs were collected if reported by clinician. Graft loss and patient death were additionally collected out through 1 year

Additional Information

Samir Patel

Methodist Hospital

Phone: 267-808-0577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place