Trial Outcomes & Findings for Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS) (NCT NCT03697993)
NCT ID: NCT03697993
Last Updated: 2020-12-19
Results Overview
Treatment success is defined as a combination of clinical cure and microbiological success. Clinical cure is defined as: 1) Resolution of UTI symptoms from presentation and 2) No new UTI symptoms and 3) Avoidance of parenteral antibiotic therapy, in or out of hospital, at any time after randomization OR oral antibiotic therapy different from per protocol. Microbiological success is defined as a reduction of the pathogen found at presentation to \<10\^4 CFU/mL for non-catheter specimens or \<10\^3 for catheter specimens on urine culture. A TOC visit was scheduled at 21 days (+7 days) after randomization.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Day 21
Results posted on
2020-12-19
Participant Flow
Participants were males and non-pregnant females aged \>=18 years and diagnosed with complicated urinary tract infections (cUTIs) without bacteremia with a uropathogen. Participants were enrolled between 14NOV2018 and 03OCT2019.
Participant milestones
| Measure |
Strategy 1
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
Initiated Treatment
|
30
|
28
|
|
Overall Study
Switched Treatment
|
0
|
6
|
|
Overall Study
Treated With at Least Two Dose of Fosfomycin
|
27
|
4
|
|
Overall Study
COMPLETED
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Strategy 1
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Overall Study
Became Ineligible after Enrollment
|
1
|
3
|
|
Overall Study
Enrolled but Treatment not Administered
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Initial Urine Culture Negative
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)
Baseline characteristics by cohort
| Measure |
Strategy 1
n=32 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=30 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 19.4 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 20.7 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 19.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
cUTI
Pyelonephritis
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
cUTI
Other cUTI
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
BMI
|
27.02 kg/m^2
STANDARD_DEVIATION 7.52 • n=5 Participants
|
29.29 kg/m^2
STANDARD_DEVIATION 8.65 • n=7 Participants
|
28.12 kg/m^2
STANDARD_DEVIATION 8.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 21Population: The microbiologic Intention-to-Treat population includes all randomized participants who have a positive baseline bacterial culture of urine.
Treatment success is defined as a combination of clinical cure and microbiological success. Clinical cure is defined as: 1) Resolution of UTI symptoms from presentation and 2) No new UTI symptoms and 3) Avoidance of parenteral antibiotic therapy, in or out of hospital, at any time after randomization OR oral antibiotic therapy different from per protocol. Microbiological success is defined as a reduction of the pathogen found at presentation to \<10\^4 CFU/mL for non-catheter specimens or \<10\^3 for catheter specimens on urine culture. A TOC visit was scheduled at 21 days (+7 days) after randomization.
Outcome measures
| Measure |
Strategy 1
n=24 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=27 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Percentage of Participants Achieving Treatment Success at Test of Cure (TOC)
|
55 percentage of participants
Interval 36.0 to 73.0
|
73 percentage of participants
Interval 54.0 to 86.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 12Population: The fosfomycin safety population includes all subjects treated with at least two doses of fosfomycin.
Solicited AEs are AEs that are common following administration of these types of antibiotics. The solicited AEs were collected after first dose of study product was given and until the end of therapy (EOT). If subject is on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurs last. The solicited AEs includes insomnia, headache, dizziness, nausea, vomiting, constipation, diarrhea, back pain, rhinitis, pharyngitis, allergic reaction, and candidiasis.
Outcome measures
| Measure |
Strategy 1
n=27 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=4 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Number of Participants Reporting Solicited Adverse Events (AEs) Grade 2 and Above Among Those Who Received Fosfomycin
|
19 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 12Population: The fosfomycin safety population includes all subjects treated with at least two doses of fosfomycin.
The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of Fosfomycin until the end of therapy (EOT) or 2 days after last dose of Fosfomycin, whichever occurs last.
Outcome measures
| Measure |
Strategy 1
n=27 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=4 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs) Grade 2 and Above Among Those Who Received Fosfomycin
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 21Population: The Fosfomycin safety population includes all subjects treated with at least two doses of Fosfomycin.
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Events are included if deemed by the investigator to be related to the study product. SAEs were only recorded in participants receiving at least two doses of fosfomyci.
Outcome measures
| Measure |
Strategy 1
n=27 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=4 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) Among Those Who Received at Least Two Doses of Fosfomyci
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 21Population: The safety population includes all enrolled participants who received at least one dose of study drug.
Solicited AEs are AEs that are common following administration of these types of antibiotics. The solicited AEs were collected after first dose of study product was given and until the end of therapy (EOT). If subject is on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurs last. The solicited AEs includes insomnia, headache, dizziness, nausea, vomiting, constipation, diarrhea, back pain, rhinitis, pharyngitis, allergic reaction, and candidiasis.
Outcome measures
| Measure |
Strategy 1
n=30 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=28 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Adverse Events (AEs)
|
67 percentage of participants
Interval 48.8 to 80.8
|
68 percentage of participants
Interval 49.3 to 82.1
|
SECONDARY outcome
Timeframe: Day 1 through Day 21Population: The safety population includes all enrolled participants who received at least one dose of study drug.
Solicited AEs are AEs that are common following administration of these types of antibiotics. The solicited AEs were collected after first dose of study product was given and until the end of therapy (EOT). If subject is on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurs last. The solicited AEs includes insomnia, headache, dizziness, nausea, vomiting, constipation, diarrhea, back pain, rhinitis, pharyngitis, allergic reaction, and candidiasis.
Outcome measures
| Measure |
Strategy 1
n=30 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=28 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Adverse Events (AEs) by Severity
Moderate
|
53 percentage of participants
Interval 36.0 to 70.0
|
50 percentage of participants
Interval 33.0 to 67.0
|
|
Percentage of Participants Reporting Solicited Adverse Events (AEs) by Severity
Severe
|
13 percentage of participants
Interval 5.0 to 30.0
|
18 percentage of participants
Interval 8.0 to 36.0
|
SECONDARY outcome
Timeframe: Day 5 through Day 10Population: The microbiologic Intention-to-Treat population includes all randomized participants who have a positive baseline bacterial culture of urine.
Treatment success is defined as a combination of clinical cure and microbiological success. Clinical cure is defined as: 1) Resolution of UTI symptoms from presentation and 2) No new UTI symptoms and 3) Avoidance of parenteral antibiotic therapy, in or out of hospital, at any time after randomization OR oral antibiotic therapy different from per protocol. Microbiological success is defined as a reduction of the pathogen found at presentation to \<10\^4 CFU/mL for non-catheter specimens or \<10\^3 for catheter specimens on urine culture. The EOT visit occured within 2 days of the completion of oral therapy.
Outcome measures
| Measure |
Strategy 1
n=24 Participants
Fosfomycin 3 grams oral powder once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion, OR the subject has an underlying condition posing increased risk for adverse events from quinolone therapy. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Levofloxacin 750 mg oral tablet once daily (Strategy 1 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
Strategy 2
n=27 Participants
Levofloxacin 750 mg oral tablet once daily for 5-7 days as initial or step-down oral therapy for cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy, and if indicated a subsequent investigator-directed adjustment to another adequate oral therapy.
Investigator-directed adjustment to another adequate oral therapy is allowed if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigator's discretion. The duration of oral therapy (initial + subsequent if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl).
Another adequate oral therapy is defined as an oral therapy to which the pathogen shows in-vitro susceptibility AND to which the subject is tolerant based on history AND which is listed below:
* Fosfomycin 3 grams oral powder once daily (Strategy 2 only)
* Amoxicillin-clavulanate 875/125 mg oral tablet twice daily
* Cefixime 400 mg oral tablet once daily
* Trimethoprim-sulfamethoxazole (TMP-SMX 160/800 mg) double-strength oral tablet twice daily
|
|---|---|---|
|
Percentage of Participants Achieving Treatment Success at End of Therapy (EOT)
|
67 percentage of participants
Interval 47.0 to 82.0
|
67 percentage of participants
Interval 49.0 to 82.0
|
Adverse Events
Fosfomycin
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Levofloxacin
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cefixime
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fosfomycin
n=35 participants at risk
Fosfomycin was administered orally as a single 3 gram dose sachet once daily for normal kidney function or every other day for CrCl less than or equal to 20 mL/min.
|
Levofloxacin
n=22 participants at risk
Levofloxacin was administered orally as 750 mg tablet once daily for normal kidney function, 750 mg tablet every other day for CrCl 20-49 mL/min; 500 mg tablet every other day for CrCl \<20 mL/min.
|
Cefixime
n=1 participants at risk
Cefixime was administered orally as 400mg tablet or capsule once daily for normal kidney function; 260 mg of oral suspension once daily for subjects with CrCl between 21-59 mL/min; 200 mg chewable table once daily for subjects with CrCl less than or equal to 20 mL/min.
|
|---|---|---|---|
|
Renal and urinary disorders
Hydronephrosis
|
2.9%
1/35 • Number of events 1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
—
0/0 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
—
0/0 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
|
Nervous system disorders
Seizure
|
2.9%
1/35 • Number of events 1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
—
0/0 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
—
0/0 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
Other adverse events
| Measure |
Fosfomycin
n=35 participants at risk
Fosfomycin was administered orally as a single 3 gram dose sachet once daily for normal kidney function or every other day for CrCl less than or equal to 20 mL/min.
|
Levofloxacin
n=22 participants at risk
Levofloxacin was administered orally as 750 mg tablet once daily for normal kidney function, 750 mg tablet every other day for CrCl 20-49 mL/min; 500 mg tablet every other day for CrCl \<20 mL/min.
|
Cefixime
n=1 participants at risk
Cefixime was administered orally as 400mg tablet or capsule once daily for normal kidney function; 260 mg of oral suspension once daily for subjects with CrCl between 21-59 mL/min; 200 mg chewable table once daily for subjects with CrCl less than or equal to 20 mL/min.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
54.3%
19/35 • Number of events 57 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
9.1%
2/22 • Number of events 2 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
0.00%
0/1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Number of events 8 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
31.8%
7/22 • Number of events 15 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
0.00%
0/1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 7 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
9.1%
2/22 • Number of events 2 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
0.00%
0/1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.9%
8/35 • Number of events 16 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
27.3%
6/22 • Number of events 14 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
0.00%
0/1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
9.1%
2/22 • Number of events 10 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
0.00%
0/1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Number of events 4 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
9.1%
2/22 • Number of events 4 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
0.00%
0/1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
|
Psychiatric disorders
Insomnia
|
8.6%
3/35 • Number of events 4 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
31.8%
7/22 • Number of events 16 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
0.00%
0/1 • The solicited events were collected after first dose of study product was given and until the end of therapy (EOT). If subject was on fosfomycin, solicited AEs were collected for 2 days after last dose of fosfomycin or until EOT, whichever occurred last. The unsolicited AEs were collected in participants who received at least two doses of Fosfomycin from the time of second dose of fosfomycin until the end of therapy (EOT) or 2 days after last dose of fosfomycin, whichever occurred last.
Serious Adverse Events (SAEs) were only recorded in participants receiving at least two doses of fosfomycin and were not collected for other interventions. Therefore the at risk population for SAE is a subset of the safety population who received any study drug.
|
Additional Information
Nadine Rouphael, MD, MSc
Vaccine Treatment Evaluation Unit (VTEU)
Phone: (404) 822-1411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60