Urinary Tract Infection (UTI)Phase 3NCT02728089
Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
A Phase 3 study testing MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) in people with Urinary Tract Infection (UTI) and Complicated Urinary Tract Infection, run by Merck Sharp & Dohme LLC.
Trial summary
This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or complicated pyelonephritis and complicated lower urinary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection (UTI), Complicated Urinary Tract Infection, Pyelonephritis
- What is being tested?
- MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2016to 5 Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese males or females who need hospitalization
- Clinical signs and/or symptoms of urinary tract infection (UTI) at screening visit, either one of the following:
- Pyelonephritis (uncomplicated or complicated)
- Complicated lower UTI (cUTI)
- Has a pretreatment baseline urine culture specimen obtained within 24 hours of start of study drug
- Requires IV antibacterial therapy for the treatment of the presumed UTI
- Female participants of child bearing potential must not be pregnant (negative human chorionic gonadotropin test) or breastfeeding and must agree to use adequate contraception for the duration of the study and up to 35 days after the last dose of study drug
- Male participants must agree to use adequate contraception for the duration of the study and up to 75 days after the last dose of study drug
Who cannot join
- Has a history of recent or recurrent Gram-positive organism UTI suggesting colonization, or participant with UTI that shows or suspects the presence of a Gram-positive organism only
- Has a history of any moderate or severe hypersensitivity or allergic reaction to any Beta-lactam antibacterial including cephalosporins, carbapenems and penicillins, or tazobactam
- Has a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to study drug with the exception of an antibacterial with Gram-positive activity only (vancomycin, linezolid, daptomycin and teicoplanin)
- Is receiving probenecid
- Is currently receiving bladder infusions with topical urinary antiseptics or antibacterial agents
- Has received any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
Show all 20Show fewer
- Has received any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the pretreatment baseline urine is obtained
- Intractable urinary infection at baseline that would require more than 7 days of study drug
- Has complete, permanent obstruction of the urinary tract.
- Has confirmed fungal urinary tract infection at time of randomization (with ≥ 10^3 fungal colony forming units /mL)
- Has permanent indwelling bladder catheter or urinary stent including nephrostomy
- Has suspected or confirmed perinephric or intrarenal abscess
- Has suspected or confirmed prostatitis, urethritis, or epididymitis
- Has ileal loop or known vesico-ureteral reflux
- Severe impairment of renal function including an estimated CrCl < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/hr urine output over 24 hours)
- Has urinary catheter that is not scheduled to be removed before the end of therapy
- Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, and septic shock
- Has an immunocompromising condition (i.e., AIDS, hematological malignancy, or bone marrow transplantation, or immunosuppressive therapy) or is receiving ≥ 40 mg of prednisone per day administered continuously for > 14 days prior to study start
- Has participated in any clinical study of an investigational product within 30 days prior to the first dose of study drug
- Has previously participated in any study of ceftolozane or MK-7625A.
About this study
Official title: A Multicenter, Open-label, Noncomparative, Japanese Phase III Study to Assess the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) in Japanese Patients With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection
This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or complicated pyelonephritis and complicated lower urinary tract infection) in Japanese participants. Efficacy will be primarily assessed by microbiological response defined as eradication of the baseline pathogen or pathogens.
- Conditions
- Urinary Tract Infection (UTI), Complicated Urinary Tract Infection, Pyelonephritis, Uncomplicated Pyelonephritis
- Being tested
- MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)Drug
MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| MK-7625A | Experimental | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. Receives: Drug: MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC)
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at TOC (14 days post first dose). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded.
Measured: Day 14 (14 days post first dose of study drug)
Percentage of Participants Who Report 1 or More Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized.
Measured: Up to 42 days post first dose of study drug
Percentage of Participants Discontinuing Study Drug Due to an AE
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued during the study due to an AE was summarized.
Measured: Up to 7 days after the first dose of study drug
Secondary outcomes (9)
Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT)
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at EOT (7 days post first dose of study drug). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded.
Measured: Day 7 (7 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU)
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at LFU (42 days post first dose of study drug). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded.
Measured: Day 42 (42 days post first dose of study drug)
Percentage of Participants With Clinical Response of Clinical Cure at TOC
The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at TOC was summarized
Measured: Day 14 (14 days post first dose of study drug)
Percentage of Participants With Clinical Response of Clinical Cure at EOT
The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at EOT was summarized
Measured: Day 7 (7 days post first dose of study drug)
Percentage of Participants With Clinical Response of Clinical Cure at LFU
The Investigator classified clinical outcome as "clinical cure", "clinical failure", or "indeterminate". A favorable clinical response is "clinical cure" defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as "indeterminate" were excluded. Percentage of participants with clinical response of clinical cure at LFU was summarized.
Measured: Day 42 (42 days post first dose of study drug)
Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC
The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized.
Measured: Day 14 (14 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen at EOT (7 days post first dose of study drug) was summarized.
Measured: Day 7 (7 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced), the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen at TOC (14 days post first dose of study drug) was summarized.
Measured: Day 14 (14 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as "Eradication", "Persistence" or "Indeterminate." A successful microbiological response was "Eradication" which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as "indeterminate" were excluded. The percentage of participants that achieved eradication for each uropathogen LFU (42 days post first dose of study drug) was summarized.
.
Measured: Day 42 (42 days post first dose of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start14 Apr 2016
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection (UTI)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728089
- Sponsor's protocol ID
- 7625A-014
- Other IDs
- MK-7625A-014, 163276
- Status last verified
- Jan 2019
- First submitted
- 30 Mar 2016
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Arakawa S, Kawahara K, Kawahara M, Yasuda M, Fujimoto G, Sato A, Yokokawa R, Yoshinari T, Rhee EG, Aoyama N. The efficacy and safety of tazobactam/ceftolozane in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. J Infect Chemother. 2019 Feb;25(2):104-110. doi: 10.1016/j.jiac.2018.10.009. Epub 2018 Nov 9.
PubMed 30420153
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Noncomparative, Japanese Phase III Study to Assess the Efficacy and Safety of Ceftolozane/Tazobactam (MK-7625A) in Japanese Patients With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT02728089
- Acronym / sponsor ID
- 7625A-014
- Conditions
- Urinary Tract Infection (UTI), Complicated Urinary Tract Infection, Pyelonephritis, Uncomplicated Pyelonephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Posted 19 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or complicated pyelonephritis and complicated lower urinary tract infection) in Japanese participants. Efficacy will be primarily assessed by microbiological response defined as eradication of the baseline pathogen or pathogens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-7625A | Experimental | Drug: MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion every 8 hours for 7 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Japanese males or females who need hospitalization
- Clinical signs and/or symptoms of urinary tract infection (UTI) at screening visit, either one of the following:
- Has a pretreatment baseline urine culture specimen obtained within 24 hours of start of study drug
- Requires IV antibacterial therapy for the treatment of the presumed UTI
- Female participants of child bearing potential must not be pregnant (negative human chorionic gonadotropin test) or breastfeeding and must agree to use adequate contraception for the duration of the study and up to 35 days after the last dose of study drug
Key exclusion criteria (20 listed)
- Has a history of recent or recurrent Gram-positive organism UTI suggesting colonization, or participant with UTI that shows or suspects the presence of a Gram-positive organism only
- Has a history of any moderate or severe hypersensitivity or allergic reaction to any Beta-lactam antibacterial including cephalosporins, carbapenems and penicillins, or tazobactam
- Has a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to study drug with the exception of an antibacterial with Gram-positive activity only (vancomycin, linezolid, daptomycin and teicoplanin)
- Is receiving probenecid
- Is currently receiving bladder infusions with topical urinary antiseptics or antibacterial agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion | Drug | MK-7625A |
Primary outcome
Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC)
Time frame: Day 14 (14 days post first dose of study drug)
The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at TOC (14 days post first dose). Microbiological outcome was classified as "eradication", "persistence" or "indeterminate." A successful microbiological response was "eradication" which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was" persistence" (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as "indeterminate" were excluded.
Percentage of Participants Who Report 1 or More Adverse Event (AE)
Time frame: Up to 42 days post first dose of study drug
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized.
Percentage of Participants Discontinuing Study Drug Due to an AE
Time frame: Up to 7 days after the first dose of study drug
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued during the study due to an AE was summarized.
9 secondary outcomes
Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT)
Time frame: Day 7 (7 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU)
Time frame: Day 42 (42 days post first dose of study drug)
Percentage of Participants With Clinical Response of Clinical Cure at TOC
Time frame: Day 14 (14 days post first dose of study drug)
Percentage of Participants With Clinical Response of Clinical Cure at EOT
Time frame: Day 7 (7 days post first dose of study drug)
Percentage of Participants With Clinical Response of Clinical Cure at LFU
Time frame: Day 42 (42 days post first dose of study drug)
Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC
Time frame: Day 14 (14 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT
Time frame: Day 7 (7 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC
Time frame: Day 14 (14 days post first dose of study drug)
Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU
Time frame: Day 42 (42 days post first dose of study drug)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30420153Arakawa S, Kawahara K, Kawahara M, Yasuda M, Fujimoto G, Sato A, Yokokawa R, Yoshinari T, Rhee EG, Aoyama N. The efficacy and safety of tazobactam/ceftolozane in Japanese patients with uncomplicated pyelonephritis and complicated urinary tract infection. J Infect Chemother. 2019 Feb;25(2):104-110. doi: 10.1016/j.jiac.2018.10.009. Epub 2018 Nov 9.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) in people with Urinary Tract Infection (UTI) and Complicated Urinary Tract Infection, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) (time frame: Day 14 (14 days post first dose of study drug)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.