Trial · NCT03230838
MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
NCT03230838, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2021-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034). Trials, record NCT03230838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03230838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
- NCT number
- NCT03230838
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 134 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Complicated Urinary Tract Infection, Pyelonephritis
- Interventions
- Ceftolozane/Tazobactam, Meropenem
- First posted
- 2017-07-26
- Last updated
- 2023-05-06
- Other registries' IDs
- eudract:2016-004153-32
- Results first posted
- 2021-12-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With ≥1 Adverse Events (AEs) | Up to Day 88 | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
| Primary | Number of Participants Discontinuing Study Therapy Due to AE | Up to Day 15 | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
| Secondary | Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit | Up to Test of Cure Visit (up to 35 days) | Clinical response of cure is complete resolution or marked improvement in signs and symptoms of the complicated urinary tract infection (cUTI) or return to pre-infection signs and symptoms, such that no further antibiotic therapy (IV or oral) is required for the treatment of the cUTI. The 95% confidence intervals (CIs) of each treatment are unstratified Wilson CIs. |
| Secondary | Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit | Up to 48 hours after last oral dose (up to 19 days) | Clinical response of cure is complete resolution or marked improvement in signs and symptoms of the cUTI or return to pre-infection signs and symptoms, such that no further antibiotic therapy (IV or oral) is required for the treatment of the cUTI. The 95% CIs of each treatment are unstratified Wilson CIs. |
| Secondary | Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit | Up to Test of Cure Visit (up to 35 days) | Microbiological eradication of all baseline pathogens is defined as a postbaseline urine culture shows all uropathogens found at baseline at ≥10\^5 colony-forming units (CFU)/mL are reduced to \<10\^4 CFU/mL. The 95% CIs of each treatment are unstratified Wilson CIs. |
| Secondary | Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the End of Treatment Visit | Up to 48 hours after last oral dose (up to 19 days) | Microbiological eradication of all baseline pathogens is defined as a postbaseline urine culture shows all uropathogens found at baseline at ≥10\^5 colony-forming units (CFU)/mL are reduced to \<10\^4 CFU/mL. The 95% CIs of each treatment are unstratified Wilson CIs. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With ≥1 Adverse Events (AEs) | Up to Day 88 | All randomized participants who received any amount of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Discontinuing Study Therapy Due to AE | Up to Day 15 | All randomized participants who received any amount of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit | Up to Test of Cure Visit (up to 35 days) | All randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit | Up to 48 hours after last oral dose (up to 19 days) | All randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit | Up to Test of Cure Visit (up to 35 days) | All randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the End of Treatment Visit | Up to 48 hours after last oral dose (up to 19 days) | All randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With ≥1 Adverse Events (AEs) | Ceftolozane/Tazobactam | 59 | Participants | ||
| Number of Participants With ≥1 Adverse Events (AEs) | Meropenem | 20 | Participants | ||
| Number of Participants Discontinuing Study Therapy Due to AE | Ceftolozane/Tazobactam | 1 | Participants | ||
| Number of Participants Discontinuing Study Therapy Due to AE | Meropenem | 0 | Participants | ||
| Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit | Ceftolozane/Tazobactam | 88.7 | 95% Confidence Interval 79.31 to 94.18 | Percentage of participants | |
| Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit | Meropenem | 95.8 | 95% Confidence Interval 79.76 to 99.26 | Percentage of participants | |
| Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit | Ceftolozane/Tazobactam | 94.4 | 95% Confidence Interval 86.39 to 97.79 | Percentage of participants | |
| Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit | Meropenem | 100.0 | 95% Confidence Interval 86.20 to 100.00 | Percentage of participants | |
| Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit | Ceftolozane/Tazobactam | 84.5 | 95% Confidence Interval 74.35 to 91.12 | Percentage of participants | |
| Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit | Meropenem | 87.5 | 95% Confidence Interval 69.00 to 95.66 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftolozane/Tazobactam | 101 | |
| Overall Study | STARTED | Meropenem | 33 | |
| Overall Study | Treated | Ceftolozane/Tazobactam | 100 | |
| Overall Study | Treated | Meropenem | 33 | |
| Overall Study | COMPLETED | Ceftolozane/Tazobactam | 97 | |
| Overall Study | COMPLETED | Meropenem | 33 | |
| Overall Study | NOT COMPLETED | Ceftolozane/Tazobactam | 4 | |
| Overall Study | NOT COMPLETED | Meropenem | 0 |
Source ClinicalTrials.gov
Adverse events26
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 | Thrombocytosis | Blood and lymphatic system disorders | Ceftolozane/Tazobactam | 7 | 100 | 7 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Meropenem | 3 | 33 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Ceftolozane/Tazobactam | 7 | 100 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Meropenem | 3 | 33 | 3 |
| other | Pyrexia | General disorders | Ceftolozane/Tazobactam | 6 | 100 | 9 |
| other | Pyrexia | General disorders | Meropenem | 0 | 33 | 0 |
| other | Rhinitis | Infections and infestations | Ceftolozane/Tazobactam | 2 | 100 | 2 |
| other | Rhinitis | Infections and infestations | Meropenem | 2 | 33 | 2 |
| other | Urinary tract infection | Infections and infestations | Ceftolozane/Tazobactam | 1 | 100 | 1 |
| other | Urinary tract infection | Infections and infestations | Meropenem | 3 | 33 | 3 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftolozane/Tazobactam | 0 | 101 |
| Total, all-cause mortality | Meropenem | 0 | 33 |
| Total, other adverse events | Ceftolozane/Tazobactam | 25 | 100 |
| Total, other adverse events | Meropenem | 10 | 33 |
| Total, serious adverse events | Ceftolozane/Tazobactam | 3 | 100 |
| Total, serious adverse events | Meropenem | 2 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36689671 | RESULT |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ceftolozane/Tazobactam vs Meropenem: Number of Participants Discontinuing Study Therapy Due to AE | Trial comparisons |
| Ceftolozane/Tazobactam vs Meropenem: Number of Participants With ≥1 Adverse Events (AEs) | Trial comparisons |
| Ceftolozane/Tazobactam vs Meropenem: deaths from any cause | Trial comparisons |
| Ceftolozane/Tazobactam vs Meropenem: serious adverse events | Trial comparisons |
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.
GET https://conductscience.org/api/trials/v1/NCT03230838
GET https://conductscience.org/api/trials/v1/NCT03230838/events?page=2