Phase
Condition
Nephritis
Nephropathy
Kidney Failure
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
Meegomäe, Voru
EstoniaSite Not Available
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