A Phase 2 interventional study of Ceftolozane/Tazobactam and Meropenem in Complicated Urinary Tract Infection and Pyelonephritis, sponsored by Merck Sharp & Dohme LLC. Completed at 52 sites in 10 countries. Open to participants aged 7 Days to 17 Years. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.
79 studies on the registry are indexed under Pyelonephritis; 12 are open to participants now.
This study's enrollment of 134 is below the median of 175 across 62 interventional studies indexed under Pyelonephritis.
Browse Pyelonephritis 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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days
Drug: Ceftolozane/Tazobactam
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
Drug: Meropenem
Drug page: Ceftolozane
12 to \<18 years of age: Ceftolozane 1 g/dose; Tazobactam 0.5 g/dose via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days. \<12 years of age: Ceftolozane 20 mg/kg with Tazobactam 10 mg/kg (not to exceed Ceftolozane 1 g and Tazobactam 0.5 g) via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days.
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.
Also known as: MERREM®
Number of Participants With ≥1 Adverse Events (AEs)
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.
Time frame: Up to Day 88
Number of Participants Discontinuing Study Therapy Due to AE
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.
Time frame: Up to Day 15
Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit
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.
Time frame: Up to Test of Cure Visit (up to 35 days)
Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit
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.
Time frame: Up to 48 hours after last oral dose (up to 19 days)
Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit
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.
Time frame: Up to Test of Cure Visit (up to 35 days)
Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the End of Treatment Visit
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.
Time frame: Up to 48 hours after last oral dose (up to 19 days)
Males and females from birth (\>32 weeks gestational age and ≥7 days postnatal), to \<18 years of age with complicated urinary tract infection (cUTI), including pyelonephritis, were enrolled in this study.
| Milestone | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| Started | 101 | 33 |
| Treated | 100 | 33 |
| Completed | 97 | 33 |
| Not completed | 4 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Temperature excursion | 1 | 0 |
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.
| Participants | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| Number of Participants With ≥1 Adverse Events (AEs) | 59 | 20 |
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.
| Participants | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| Number of Participants Discontinuing Study Therapy Due to AE | 1 | 0 |
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.
| Percentage of participants | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit | 88.7 (79.31 to 94.18) | 95.8 (79.76 to 99.26) |
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.
| Percentage of participants | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit | 94.4 (86.39 to 97.79) | 100.0 (86.20 to 100.00) |
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.
| Percentage of participants | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit | 84.5 (74.35 to 91.12) | 87.5 (69.00 to 95.66) |
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.
| Percentage of participants | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the End of Treatment Visit | 93.0 (84.55 to 96.95) | 95.8 (79.76 to 99.26) |
Collected over Adverse Events (AEs): From treatment (Day 1) up to 88 days. All-cause mortality: From randomization (Day 1) up to 88 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ceftolozane/Tazobactam | 0/101 (0%) | 3/100 (3%) | 25/100 (25%) |
| Meropenem | 0/33 (0%) | 2/33 (6.1%) | 10/33 (30.3%) |
| Event | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| PyrexiaGeneral disorders | 0/100 | 1/33 |
| HypertensionVascular disorders | 0/100 | 1/33 |
| PyelonephritisInfections and infestations | 1/100 | 0/33 |
| Pyelonephritis acuteInfections and infestations | 1/100 | 0/33 |
| Upper respiratory tract infectionInfections and infestations | 1/100 | 0/33 |
| Event | Ceftolozane/Tazobactam | Meropenem |
|---|---|---|
| ThrombocytosisBlood and lymphatic system disorders | 7/100 | 3/33 |
| DiarrhoeaGastrointestinal disorders | 7/100 | 3/33 |
| Urinary tract infectionInfections and infestations | 1/100 | 3/33 |
| RhinitisInfections and infestations | 2/100 | 2/33 |
| VulvovaginitisInfections and infestations | 0/100 | 2/33 |
| Alanine aminotransferase increasedInvestigations | 4/100 | 2/33 |
| Aspartate aminotransferase increasedInvestigations | 4/100 | 2/33 |
| PyrexiaGeneral disorders | 6/100 | 0/33 |
| Age, Continuous(Years) | Ceftolozane/Tazobactam | Meropenem | Total |
|---|---|---|---|
| Mean | 5.3 ± 5.3 | 5.5 ± 5.7 | 5.4 ± 5.4 |
| Sex: Female, Male(Participants) | Ceftolozane/Tazobactam | Meropenem | Total |
|---|---|---|---|
| Female | 65 | 20 | 85 |
| Male | 36 | 13 | 49 |
| Ethnicity (NIH/OMB)(Participants) | Ceftolozane/Tazobactam | Meropenem | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 5 | 14 |
| Not Hispanic or Latino | 81 | 27 | 108 |
| Unknown or Not Reported | 11 | 1 | 12 |
| Race (NIH/OMB)(Participants) | Ceftolozane/Tazobactam | Meropenem | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 100 | 33 | 133 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
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Studies of the drug tested here: Ceftolozane