Trial · NCT02728089
Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
NCT02728089, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2018-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014). Trials, record NCT02728089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02728089
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
- NCT number
- NCT02728089
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 115 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Urinary Tract Infection (UTI), Complicated Urinary Tract Infection, Pyelonephritis, Uncomplicated Pyelonephritis
- Interventions
- MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)
- First posted
- 2016-04-05
- Last updated
- 2019-02-05
- Results first posted
- 2018-09-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) | 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. |
| Primary | Percentage of Participants Who Report 1 or More Adverse Event (AE) | 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. |
| Primary | Percentage of Participants Discontinuing Study Drug Due to an AE | 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. |
| Secondary | Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT) | Day 7 (7 days post first dose of study drug) | 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. |
| Secondary | Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU) | Day 42 (42 days post first dose of study drug) | 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. |
| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at TOC | Day 14 (14 days post first dose of study drug) | 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 |
| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at EOT | Day 7 (7 days post first dose of study drug) | 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 |
| Secondary | Percentage of Participants With Clinical Response of Clinical Cure at LFU | Day 42 (42 days post first dose of study drug) | 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. |
| Secondary | Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC | Day 14 (14 days post first dose of study drug) | The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized. |
| Secondary | Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT | Day 7 (7 days post first dose of study drug) | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) | Day 14 (14 days post first dose of study drug) | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Report 1 or More Adverse Event (AE) | Up to 42 days post first dose of study drug | All participants who received at least 1 dose of study treatment and had follow-up data for endpoint. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Discontinuing Study Drug Due to an AE | Up to 7 days after the first dose of study drug | All participants who received at least 1 dose of study treatment and had follow-up data for endpoint. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT) | Day 7 (7 days post first dose of study drug) | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU) | Day 42 (42 days post first dose of study drug) | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Clinical Cure at TOC | Day 14 (14 days post first dose of study drug) | All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Clinical Cure at EOT | Day 7 (7 days post first dose of study drug) | All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Clinical Cure at LFU | Day 42 (42 days post first dose of study drug) | All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC | Day 14 (14 days post first dose of study drug) | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT | Day 7 (7 days post first dose of study drug) | All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest. | Percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC) | MK-7625A | 80.7 | 95% Confidence Interval 70.9 to 88.3 | Percentage of participants | |
| Percentage of Participants Who Report 1 or More Adverse Event (AE) | MK-7625A | 58.8 | 95% Confidence Interval 49.2 to 67.9 | Percentage of participants | |
| Percentage of Participants Discontinuing Study Drug Due to an AE | MK-7625A | 1.8 | 95% Confidence Interval 0.2 to 6.2 | Percentage of participants | |
| Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT) | MK-7625A | 100.0 | 95% Confidence Interval 95.8 to 100.0 | Percentage of participants | |
| Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU) | MK-7625A | 61.0 | 95% Confidence Interval 49.6 to 71.6 | Percentage of participants | |
| Percentage of Participants With Clinical Response of Clinical Cure at TOC | MK-7625A | 96.6 | 95% Confidence Interval 90.5 to 99.3 | Percentage of participants | |
| Percentage of Participants With Clinical Response of Clinical Cure at EOT | MK-7625A | 97.8 | 95% Confidence Interval 92.1 to 99.7 | Percentage of participants | |
| Percentage of Participants With Clinical Response of Clinical Cure at LFU | MK-7625A | 78.2 | 95% Confidence Interval 68.0 to 86.3 | Percentage of participants | |
| Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC | MK-7625A | 80.7 | 95% Confidence Interval 70.9 to 88.3 | Percentage of participants | |
| Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT | MK-7625A | Enterobacter aerogenes | 100.0 | 95% Confidence Interval 2.5 to 100.0 | Percentage of participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-7625A | 115 | |
| Overall Study | Treated | MK-7625A | 114 | |
| Overall Study | COMPLETED | MK-7625A | 112 | |
| Overall Study | NOT COMPLETED | MK-7625A | 3 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | MK-7625A | 9 | 114 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | MK-7625A | 9 | 114 | 9 |
| other | Alanine aminotransferase increased | Investigations | MK-7625A | 9 | 114 | 9 |
| other | Aspartate aminotransferase increased | Investigations | MK-7625A | 7 | 114 | 7 |
| serious | Cardiac failure | Cardiac disorders | MK-7625A | 1 | 114 | 1 |
| serious | Gastritis | Gastrointestinal disorders | MK-7625A | 1 | 114 | 1 |
| serious | Ileus | Gastrointestinal disorders | MK-7625A | 1 | 114 | 1 |
| serious | Rectal prolapse | Gastrointestinal disorders | MK-7625A | 1 | 114 | 1 |
| serious | Cholelithiasis | Hepatobiliary disorders | MK-7625A | 1 | 114 | 1 |
| serious | Pneumonia bacterial | Infections and infestations | MK-7625A | 1 | 114 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-7625A | 0 | 114 |
| Total, other adverse events | MK-7625A | 26 | 114 |
| Total, serious adverse events | MK-7625A | 13 | 114 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30420153 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02728089/results?page=2