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Complicated Urinary Tract InfectionPhase 2NCT03230838

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

A Phase 2 study testing Ceftolozane/Tazobactam and Meropenem in people with Complicated Urinary Tract Infection and Pyelonephritis, run by Merck Sharp & Dohme LLC at 52 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 7 days to 17 years
What is being tested?
Ceftolozane/Tazobactam and Meropenem
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
52 sitesin 10 countries
Study dates
26 Apr 2018to 3 Dec 2020
Phase
Phase 2
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 7 days to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Has a legally acceptable representative who provides documented informed consent / assent for the trial.
  • Ages from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18 years of age.
  • Requires IV antibacterial therapy for the treatment of cUTI.
  • Have a pretreatment baseline urine culture specimen obtained within 48 hours before the start of administration of the first dose of study treatment and preferably prior to administration of any potentially therapeutic antibiotics.
  • Has pyuria.
  • Has clinical signs and/or symptoms of cUTI at the Screening Visit.
  • Is not of reproductive potential; but if of reproductive potential agrees to avoid becoming pregnant or impregnating a partner during screening, while receiving study treatment and for at least 30 days after the last dose of study treatment.
  • Female of reproductive potential is not pregnant, and not planning to become pregnant within 30 days of the last day of treatment administration; and is nonlactating.

Who cannot join

  • Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days prior to the first dose of study treatment in this current trial.
  • Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or has enrolled previously in the current trial and been discontinued.
  • Has a history of any moderate or severe hypersensitivity (e.g.anaphylaxis), allergic reaction, or other contraindication to any of the following: β-lactam antibiotics (e.g, penicillins, cephalosporins, and carbapenems), β-lactamase inhibitors (e.g. tazobactam, sulbactam, clavulanic acid, avibactam), or metronidazole.
  • Has a history of a cUTI within the past 1 year prior to randomization known to be caused by a pathogen resistant to either IV study treatment.
  • Has a concomitant infection at the time of randomization that requires nonstudy systemic antibacterial therapy in addition to IV study treatment or oral step -down therapy.
  • Has received potentially therapeutic antibacterial therapy for a duration more than 24 hours during the 48 hours preceding the first dose of study treatment.
Show all 14Show fewer
  • Has any of the following: a) intractable UTI or pyelonephritis infection at baseline that the Investigator anticipates would require more than 14 days of study treatment; b) confirmed fungal urinary tract infection at time of randomization; c) permanent indwelling bladder catheter or instrumentation including nephrostomy; d) current urinary catheter that is not scheduled to be removed before the end of all study treatment; e) complete, permanent obstruction of the urinary tract; f) suspected or confirmed perinephric or intrarenal abscess; g) documented ileal loop reflux; h) suspected or confirmed prostatitis, urethritis, or epididymitis; i) trauma to pelvis/urinary tract.
  • Has moderate or severe impairment of renal function.
  • Has a seizure disorder or is anticipated to be treated with divalproex sodium or valproic acid during the course of study treatment.
  • Is receiving, or is expected to receive, any prohibited medications.
  • Has any rapidly progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure, or septic shock.
  • Has an immunocompromising condition.
  • Has a history of malignancy ≤5 years prior to signing informed consent.
  • Is planning to receive suppressive/prophylactic antibiotics with gram-negative activity after completion of study treatment.

Trial locations and contacts

52 sites in 10 countries.

52 sites in 10 countries

United States9 sites

  • Our Lady of the Lake Hospital ( Site 2512)

    Baton Rouge, Louisiana, 70808

  • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2519)

    Chicago, Illinois, 60611

  • Baylor College Of Medicine ( Site 2515)

    Houston, Texas, 77030

  • Children's Hospital - Los Angeles ( Site 2509)

    Los Angeles, California, 90027

  • Children's Hospital of Orange County ( Site 2502)

    Orange, California, 92868

  • Rady Children's Hospital-San Diego ( Site 2505)

    San Diego, California, 92123

  • St. Louis Children's Hospital ( Site 2508)

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University Hospital ( Site 2510)

    Syracuse, New York, 13210

  • Wake Forest Baptist Health ( Site 2520)

    Winston-Salem, North Carolina, 27157

Other trials in United States

Ukraine7 sites

  • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 2402)

    Dnipro, Dnipropetrovsk Oblast, 49100

  • Ivano-Frankivsk Regional Children Clinical Hospital ( Site 2411)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014

  • Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2410)

    Kharkiv, Kharkiv Oblast, 61037

  • Kharkiv City Children Hospital 16 ( Site 2414)

    Kharkiv, Kharkiv Oblast, 61075

  • PI Kryvorizka city clinical hospital 8 ( Site 2408)

    Kryvyy Rig, Dnipropetrovsk Oblast, 50082

  • National Children Specialised Hospital OHMADYT MOH Ukraine ( Site 2409)

    Kyiv, Kyivska Oblast, 01135

  • Municipal Institution City Children s Clinical Hospital of Poltava City Council ( Site 2404)

    Poltava, Poltava Oblast, 36004

Other trials in Ukraine

Hungary6 sites

  • Semmelweis Egyetem ( Site 0810)

    Budapest, 1083

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0801)

    Budapest, 1089

  • Debreceni Egyetem Klinikai Kozpont ( Site 0803)

    Debrecen, 4032

  • SzSzBMK es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz ( Site 0808)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • PTE AOK Klinikai Kozpont ( Site 0809)

    Pécs, Baranya, 7623

  • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0804)

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Poland6 sites

  • Wojewodzki Szpital Obserwacyjno Zakazny ( Site 1606)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030

  • Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1600)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094

  • Uniw. Szpital Dzieciecy w Krakowie ( Site 1609)

    Krakow, Lesser Poland Voivodeship, 30-663

  • Instytut Centrum Zdrowia Matki Polki ( Site 1602)

    Lodz, Łódź Voivodeship, 93-338

  • SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1608)

    Łomianki, Masovian Voivodeship, 05-092

  • Wojewodzki Szpital Zespolony im. Rydgiera ( Site 1607)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

Other trials in Poland

Greece5 sites

  • Pan and Aglaia Kyriakou Children s Hospital ( Site 0780)

    Athens, Attica, 115 27

  • University of Athens - Aghia Sophia Childrens Hospital ( Site 0730)

    Athens, Attica, 115 27

  • Athens University Hospital ATTIKON ( Site 0790)

    Athens, Attica, 124 62

  • General University Hospital of Larissa ( Site 0740)

    Larissa, Thessaly, 411 10

  • Hippokration General Hospital of Thessaloniki ( Site 0700)

    Thessaloniki, Thessaloníki, 546 42

Other trials in Greece

Mexico4 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 1202)

    Guadalajara, Jalisco, 44280

  • Instituto Nacional de Pediatria ( Site 1201)

    Mexico City, 04530

  • Hospital Infantil de Mexico Federico Gomez ( Site 1203)

    Mexico City, 06720

  • Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 1204)

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Romania4 sites

  • Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 1703)

    Brasov, 500063

  • Spitalul Clinic de Urgenta pentru Copii Maria Sklodowska Curie ( Site 1707)

    Bucharest, Bucharest, 041451

  • Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 1706)

    Bucharest, 021106

  • Spit. Cl. de Urg. Copii Cluj Napoca ( Site 1708)

    Cluj-Napoca, Cluj, 400177

Other trials in Romania

Russia4 sites

  • Russian Pediatric Clinical Hospital ( Site 1808)

    Moscow, Moscow, 119571

  • St.Petersburg State Pediatric Medical University ( Site 1811)

    Saint Petersburg, Sankt-Peterburg, 194100

  • Smolensk Regional Clinical Hospital ( Site 1800)

    Smolensk, Smolensk Oblast, 214018

  • Regional Childrens Clinical Hospital ( Site 1805)

    Stavropol, Stavropol Kray, 355029

Other trials in Russia

Turkey (Türkiye)4 sites

  • Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2200)

    Adana, 01330

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2201)

    Ankara, 06230

  • Eskisehir Osmangazi Unv. Tip Fakultesi ( Site 2202)

    Eskişehir, 26480

  • SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 2203)

    Istanbul, 34453

Other trials in Turkey (Türkiye)

South Africa3 sites

  • Red Cross War Memorial Children's Hospital ( Site 1900)

    Cape Town, Western Cape, 7700

  • Inkosi Albert Luthuli Central Hospital ( Site 1902)

    Durban, KwaZulu-Natal, 4091

  • Molotlegi Street ( Site 1903)

    Pretoria, Gauteng, 0208

Other trials in South Africa

About this study

Official title: A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Versus Meropenem in Pediatric Subjects With Complicated Urinary Tract Infection, Including Pyelonephritis

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.

Being tested
Ceftolozane/Tazobactam, Meropenem
Medical subject headings
Pyelonephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ceftolozane/TazobactamDrug

    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.

  • MeropenemDrug

    Also called MERREM®

    Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.

Study groups in NCT03230838
Study groupRoleWhat they receive
Ceftolozane/TazobactamExperimentalCeftolozane 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
Receives: Drug: Ceftolozane/Tazobactam
MeropenemActive comparatorMeropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
Receives: Drug: Meropenem

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Day 88

  2. 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.

    Measured: Up to Day 15

Secondary outcomes (4)

  1. 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.

    Measured: Up to Test of Cure Visit (up to 35 days)

  2. 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.

    Measured: Up to 48 hours after last oral dose (up to 19 days)

  3. 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.

    Measured: Up to Test of Cure Visit (up to 35 days)

  4. 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.

    Measured: Up to 48 hours after last oral dose (up to 19 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2017
  2. Study start26 Apr 2018
  3. Primary completion3 Dec 2020
  4. Study completion3 Dec 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03230838
Sponsor's protocol ID
7625A-034
Other IDs
2016-004153-32, 2016
Status last verified
May 2023
First submitted
24 Jul 2017
Last updated
6 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Roilides E, Ashouri N, Bradley JS, Johnson MG, Lonchar J, Su FH, Huntington JA, Popejoy MW, Bensaci M, De Anda C, Rhee EG, Bruno CJ. Safety and Efficacy of Ceftolozane/Tazobactam Versus Meropenem in Neonates and Children With Complicated Urinary Tract Infection, Including Pyelonephritis: A Phase 2, Randomized Clinical Trial. Pediatr Infect Dis J. 2023 Apr 1;42(4):292-298. doi: 10.1097/INF.0000000000003832. Epub 2023 Jan 23.

    PubMed 36689671

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ceftolozane/Tazobactam and Meropenem in people with Complicated Urinary Tract Infection and Pyelonephritis, run by Merck Sharp & Dohme LLC at 52 sites in 10 countries.

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 14 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Ukraine, Hungary, Poland, Greece and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 1 Dec 2021). 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?

Number of Participants With ≥1 Adverse Events (AEs) (time frame: Up to Day 88). The study lists 2 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 NCT03230838, 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 6 May 2023.

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