Phase
Condition
Urinary Tract Infections
Gynecological Infections
Nephritis
Treatment
imipenem/cilastatin
co-administration of aztreonam and nacubactam
co-administration of cefepime and nacubactam
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients at least18 years of age (or age of legal consent, whicheveris older) at the time of obtaining informed consent and who can be hospitalizedthroughout the Treatment Period;
Weight at most 140 kg;
Expectation, in the opinion of the Investigator, that the patient's cUTI or AP willrequire treatment with at least 5 days of IV antibiotics;
Exclusion
Exclusion Criteria:
Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10^5 CFU/mL), isolated from study-qualifying urine culture; Note: If afterrandomization the susceptibility testing indicates resistance to imipenem and/ormeropenem, the patient may remain on the study drug at the Investigator'sdiscretion.
Has known or suspected single or concurrent infection with Acinetobacter spp. orother organisms that are not adequately covered by the study drug (eg, concurrentviral, mycobacterial, or fungal infection) and needs to be managed with otheranti-infectives; Note: Patients with qualifying pathogen coinfected with aGram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly withthe study drug at the Investigator's discretion.
Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolatedfrom study qualifying urine culture;
Study Design
Connect with a study center
Meiji Research Site
Pleven 728203,
BulgariaSite Not Available
Meiji Research Site
Rousse 727523,
BulgariaSite Not Available
Meiji Research Site
Silistra 727221,
BulgariaSite Not Available
Meiji Research Site
Sofia 727011,
BulgariaSite Not Available
Meiji Research Site
Beijing 1816670,
ChinaSite Not Available
Meiji Research Site
Changchun 2038180,
ChinaSite Not Available
Meiji Research Site
Chongqing 1814906,
ChinaSite Not Available
Meiji Research Site
Fuyang 1810845,
ChinaSite Not Available
Meiji Research Site
Ganzhou 1810638,
ChinaSite Not Available
Meiji Research Site
Huaian,
ChinaSite Not Available
Meiji Research Site
Huzhou 1806535,
ChinaSite Not Available
Meiji Research Site
Nanchang 1800163,
ChinaSite Not Available
Meiji Research Site
Nanning 1799869,
ChinaSite Not Available
Meiji Research Site
Quanzhou 1797353,
ChinaSite Not Available
Meiji Research Site
Shanghai 1796236,
ChinaSite Not Available
Meiji Research Site
Shantou 1795940,
ChinaSite Not Available
Meiji Research Site
Shijiazhuang 1795270,
ChinaSite Not Available
Meiji Research Site
Taian,
ChinaSite Not Available
Meiji Research Site
Tianjin 1792947,
ChinaSite Not Available
Meiji Research Site
Xuancheng 1788081,
ChinaSite Not Available
Meiji Research Site
Yunnan 7059642,
ChinaSite Not Available
Meiji Research Site
Zhejiang 9898779,
ChinaSite Not Available
Meiji Research Site
Zhengzhou 1784658,
ChinaSite Not Available
Meiji Research Site
Hradec Králové 3074967,
CzechiaSite Not Available
Meiji Research Site
Liberec 3071961,
CzechiaSite Not Available
Meiji Research Site
Prague 3067696,
CzechiaSite Not Available
Meiji Research Site
Ústí nad Labem 3063548,
CzechiaSite Not Available
Meiji Research Site
Meegomäe, Voru
EstoniaSite Not Available
Meiji Research Site
Meegomäe 794304, Võrumaa 587448
EstoniaSite Not Available
Meiji Research Site
Kohtla-Järve 591260,
EstoniaSite Not Available
Meiji Research Site
Tallinn 588409,
EstoniaSite Not Available
Meiji Research Site
Tartu 588335,
EstoniaSite Not Available
Meiji Research Site
Kutaisi 613607,
GeorgiaSite Not Available
Meiji Research Site
Rustavi 612287,
GeorgiaSite Not Available
Meiji Research Site
Tbilisi 611717,
GeorgiaSite Not Available
Meiji Research Site
Fukuyama 1863917,
JapanSite Not Available
Meiji Research Site
Gifu 1863641,
JapanSite Not Available
Meiji Research Site
Ibaraki-Town, Higashiibaraki-County,
JapanSite Not Available
Meiji Research Site
Iwakuni 1861212,
JapanSite Not Available
Meiji Research Site
Kanazawa 1860243,
JapanSite Not Available
Meiji Research Site
Kawachi-Nagano 6825498,
JapanSite Not Available
Meiji Research Site
Kofu 1859100,
JapanSite Not Available
Meiji Research Site
Kumamoto 1858421,
JapanSite Not Available
Meiji Research Site
Matsumoto 1857519,
JapanSite Not Available
Meiji Research Site
Mizumaki-Town, Onga-County,
JapanSite Not Available
Meiji Research Site
Nagasaki 1856177,
JapanSite Not Available
Meiji Research Site
Nankoku 11612330,
JapanSite Not Available
Meiji Research Site
Sagamihara 11611609,
JapanSite Not Available
Meiji Research Site
Sapporo 2128295,
JapanSite Not Available
Meiji Research Site
Shinjuku-ku,
JapanSite Not Available
Meiji Research Site
Toyota 1849814,
JapanSite Not Available
Meiji Research Site
Ueda 1849429,
JapanSite Not Available
Meiji Research Site
Yokohama 1848354,
JapanSite Not Available
Meiji Research Site
Ōita 1854487,
JapanSite Not Available
Meiji Research Site
Ōtake 1853662,
JapanSite Not Available
Meiji Research Site
Riga 456172,
LatviaSite Not Available
Meiji Research Site
Valmiera 453754,
LatviaSite Not Available
Meiji Research Site
Kaunas 598316,
LithuaniaSite Not Available
Meiji Research Site
Vilnius 593116,
LithuaniaSite Not Available
Meiji Research Site
Galanta 3060219,
SlovakiaSite Not Available
Meiji Research Site
Rimavská Sobota 723736,
SlovakiaSite Not Available
Meiji Research Site
Svidník 723417,
SlovakiaSite Not Available
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