Trial Outcomes & Findings for Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study (NCT NCT01353339)

Results Overview

BK viruria was defined as 500 copies/mL or more of BK virus DNA in the urine.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

154 participants

Primary outcome timeframe

12 months post-transplantation

Results posted on

2024-04-05

Participant Flow

The first patient was randomized on December 1, 2011, and recruitment continued until June 25, 2013. The last patient follow-up visit was February 25, 2014.

Eligible patients with written informed consent were randomly assigned to receive either levofloxacin or placebo in a 1:1 fashion. Allocation was achieved through web-based central randomization in variable blocks stratified by center. An independent statistician prepared the randomization schemes. Physicians, nurses, investigators, and research staff were blinded to the randomization scheme, and active study medication and matching placebo were identical in appearance

Participant milestones

Participant milestones
Measure	Levofloxacin Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill Levofloxacin: 500mg, PO, once daily for 3 months
Overall Study STARTED	76	78
Overall Study Discontinued Intervention	12	14
Overall Study Incomplete Follow-up	22	28
Overall Study COMPLETED	76	78
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Total n=154 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 14.2 • n=5 Participants	48.2 years STANDARD_DEVIATION 12.7 • n=7 Participants	48 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	16 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	62 Participants n=7 Participants	111 Participants n=5 Participants
Race/Ethnicity, Customized White	49 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Aboriginal	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	76 participants n=5 Participants	78 participants n=7 Participants	154 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-transplantation

BK viruria was defined as 500 copies/mL or more of BK virus DNA in the urine.

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Occurrence of BK Viruria	22 Participants	26 Participants

SECONDARY outcome

Timeframe: 12 months

Incidence and type of all adverse events

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Adverse Events	27 Participants	29 Participants

SECONDARY outcome

Timeframe: 12 months

Incidence of Acute rejection

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Acute Rejection	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 months

Incidence of microbiologically confirmed clostridium difficile associated diarrhea

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Clostridium Difficile Associated Diarrhea	36 Participants	30 Participants

SECONDARY outcome

Timeframe: 12 months

Incidence of other infections (viral, bacterial and fungal) based on established guidelines

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Infections	1.4 Number of infections per patient Standard Deviation 1.6	1.3 Number of infections per patient Standard Deviation 2.2

SECONDARY outcome

Timeframe: 12 months

Incidence of quinolone resistance where a quinolone would have been a therapeutic option

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Quinolone Resistance	14 Participants	15 Participants

SECONDARY outcome

Timeframe: 12 months

Absence of kidney function in allograft

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Allograft Loss	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Proportion of randomized participants who are adherent to the protocol.

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Adherence	68.5 Percentage of participants	70.4 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Use of quinolones outside of the protocol

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Use of Quinolones	19 Participants	14 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Proportion of Patient Drop-out and Loss to Follow-up	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
Quantitative BK Urine Viral Load	7550 copies/mL Standard Deviation 16542	4503 copies/mL Standard Deviation 5419

SECONDARY outcome

Timeframe: 12 months

BK viremia defined as ≥250 copies/mL of BK virus DNA in the plasma

Outcome measures

Outcome measures
Measure	Levofloxacin n=76 Participants Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 Participants Levofloxacin: 500mg, PO, once daily for 3 months
BK Viremia	6 Participants	9 Participants

Adverse Events

Levofloxacin

Serious events: 6 serious events

Other events: 76 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 1 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Levofloxacin n=76 participants at risk Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 participants at risk Levofloxacin: 500mg, PO, once daily for 3 months
Musculoskeletal and connective tissue disorders tendinitis	7.9% 6/76	1.3% 1/78

Other adverse events

Other adverse events
Measure	Levofloxacin n=76 participants at risk Levofloxacin: 500mg, PO, once daily for 3 months	Sugar Pill n=78 participants at risk Levofloxacin: 500mg, PO, once daily for 3 months
General disorders Hospitalization	28.9% 22/76	33.3% 26/78
Infections and infestations Over 1 infection	59.2% 45/76	44.9% 35/78
Infections and infestations Culture-positive infections	39.5% 30/76	59.0% 46/78
Gastrointestinal disorders Diarrhea	47.4% 36/76	38.5% 30/78

Additional Information

Dr. John S. Gill

St Paul's Hospital

Phone: 604-806-8970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place