A Phase 3 interventional study of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) in Urinary Tract Infection (UTI), Complicated Urinary Tract Infection and Pyelonephritis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
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.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 115 is below the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical signs and/or symptoms of urinary tract infection (UTI) at screening visit, either one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)
Drug page: Ceftolozane
MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 days after the first dose of study drug
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.
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)
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.
Time frame: 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
Time frame: 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
Time frame: 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.
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
The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized.
Time frame: 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.
Time frame: 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.
Time frame: 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. .
Time frame: Day 42 (42 days post first dose of study drug)
| Milestone | MK-7625A |
|---|---|
| Started | 115 |
| Treated | 114 |
| Completed | 112 |
| Not completed | 3 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 1 |
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 | MK-7625A |
|---|---|
| Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) | 80.7 (70.9 to 88.3) |
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 | MK-7625A |
|---|---|
| Percentage of Participants Who Report 1 or More Adverse Event (AE) | 58.8 (49.2 to 67.9) |
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.
| Percentage of participants | MK-7625A |
|---|---|
| Percentage of Participants Discontinuing Study Drug Due to an AE | 1.8 (0.2 to 6.2) |
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.
| Percentage of participants | MK-7625A |
|---|---|
| Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT) | 100.0 (95.8 to 100.0) |
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.
| Percentage of participants | MK-7625A |
|---|---|
| Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU) | 61.0 (49.6 to 71.6) |
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
| Percentage of participants | MK-7625A |
|---|---|
| Percentage of Participants With Clinical Response of Clinical Cure at TOC | 96.6 (90.5 to 99.3) |
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
| Percentage of participants | MK-7625A |
|---|---|
| Percentage of Participants With Clinical Response of Clinical Cure at EOT | 97.8 (92.1 to 99.7) |
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.
| Percentage of participants | MK-7625A |
|---|---|
| Percentage of Participants With Clinical Response of Clinical Cure at LFU | 78.2 (68.0 to 86.3) |
The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized.
| Percentage of participants | MK-7625A |
|---|---|
| Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC | 80.7 (70.9 to 88.3) |
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.
| Percentage of participants | MK-7625A |
|---|---|
| Enterobacter aerogenes | 100.0 (2.5 to 100.0) |
| Escherichia coli | 100.0 (95.3 to 100.0) |
| Klebsiella pneumoniae | 100.0 (59.0 to 100.0) |
| Proteus mirabilis | 100.0 (15.8 to 100.0) |
| Proteus vulgaris | 100.0 (15.8 to 100.0) |
| Pseudomonas aeruginosa | 100.0 (2.5 to 100.0) |
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.
| Percentage of participants | MK-7625A |
|---|---|
| Citrobacter koseri | 100.0 (2.5 to 100.0) |
| Enterobacter aerogenes | 100.0 (2.5 to 100.0) |
| Escherichia coli | 82.9 (72.5 to 90.6) |
| Klebsiella pneumoniae | 42.9 (9.9 to 81.6) |
| Proteus mirabilis | 100.0 (29.2 to 100.0) |
| Proteus vulgaris | 100.0 (15.8 to 100.0) |
| Pseudomonas aeruginosa | 100.0 (2.5 to 100.0) |
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. .
| Percentage of participants | MK-7625A |
|---|---|
| Citrobacter koseri | 100.0 (2.5 to 100.0) |
| Enterobacter aerogenes | 100.0 (2.5 to 100.0) |
| Escherichia coli | 62.9 (50.5 to 74.1) |
| Klebsiella pneumoniae | 37.5 (8.5 to 75.5) |
| Proteus mirabilis | 66.7 (9.4 to 99.2) |
| Proteus vulgaris | 100.0 (2.5 to 100.0) |
| Pseudomonas aeruginosa | 100.0 (2.5 to 100.0) |
Collected over up to 35 post last dose of study drug (up to 42 days total). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MK-7625A | 0/114 (0%) | 13/114 (11.4%) | 26/114 (22.8%) |
| Event | MK-7625A |
|---|---|
| Pyelonephritis acuteInfections and infestations | 3/114 |
| Cardiac failureCardiac disorders | 1/114 |
| GastritisGastrointestinal disorders | 1/114 |
| IleusGastrointestinal disorders | 1/114 |
| Rectal prolapseGastrointestinal disorders | 1/114 |
| CholelithiasisHepatobiliary disorders | 1/114 |
| Pneumonia bacterialInfections and infestations | 1/114 |
| PyelonephritisInfections and infestations | 1/114 |
| Pyelonephritis chronicInfections and infestations | 1/114 |
| Patella fractureInjury, poisoning and procedural complications | 1/114 |
| Event | MK-7625A |
|---|---|
| ConstipationGastrointestinal disorders | 9/114 |
| DiarrhoeaGastrointestinal disorders | 9/114 |
| Alanine aminotransferase increasedInvestigations | 9/114 |
| Aspartate aminotransferase increasedInvestigations | 7/114 |
| Age, Continuous(Years) | MK-7625A |
|---|---|
| Mean | 68.2 ± 13.8 |
| Sex: Female, Male(Participants) | MK-7625A |
|---|---|
| Female | 77 |
| Male | 38 |
| Race (NIH/OMB)(Participants) | MK-7625A |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 115 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Apr 2016 to primary completion in Sep 2017, 16 months.
Results were first posted in Sep 2018, 1 year after primary completion.
Of 23 industry-sponsored phase 3 interventional studies under Urinary Tract Infections, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 16 months is close to that.
Counting every sponsor, half of 37 studies reached it within 20 months; a quarter within 14 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ceftolozane