18 and older, any sex, with Complicated Urinary Tract Infection or Acute Pyelonephritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5Primary· Day 5
Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10\^5 colony forming units per milliliter (CFU/mL) was reduced to \<10\^4 CFU/mL. Clinical Cure at Day 5: marked improvement evidenced by complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms developed. Failure: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; adverse event (AE) requiring the discontinuation of study drug and the patient required
Composite Cure
Group
Value
95% CI
Plazomicin
88
Meropenem
91.4
Composite Failure
Group
Value
95% CI
Plazomicin
10.5
Meropenem
7.6
Indeterminate
Group
Value
95% CI
Plazomicin
1.6
Meropenem
1
Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC)Primary· Day 17 TOC Visit
Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10\^5 CFU/mL was reduced to \<10\^4 CFU/mL. Clinical Cure at TOC Visit: the complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow
Composite Cure
Group
Value
95% CI
Plazomicin
81.7
Meropenem
70.1
Composite Failure
Group
Value
95% CI
Plazomicin
15.2
Meropenem
25.9
Indeterminate
Group
Value
95% CI
Plazomicin
3.1
Meropenem
4.1
Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at Day 5Secondary· Day 5
Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10\^5 CFU/mL was reduced to \<10\^4 CFU/mL. Clinical Cure Day 5: Marked improvement defined as complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms develop. Failure Day 5: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; AE requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI.
Day 5: Composite Cure
Group
Value
95% CI
Plazomicin
89.4
Meropenem
94.2
Day 5: Composite Failure
Group
Value
95% CI
Plazomicin
10.6
Meropenem
5.8
Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at TOCSecondary· Day 17 TOC Visit
Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10\^5 CFU/mL was reduced to \<10\^4 CFU/mL. Clinical Cure TOC: Complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure TOC: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI.
TOC: Composite Cure
Group
Value
95% CI
Plazomicin
84.9
Meropenem
75.1
TOC: Composite Failure
Group
Value
95% CI
Plazomicin
15.1
Meropenem
24.9
Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs)Secondary· Up to Day 32
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that n
Group
Value
95% CI
Plazomicin
19.5
Meropenem
21.6
Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0-24h)Secondary· Day 3
PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.
Group
Value
95% CI
Plazomicin
234
± 38.5
Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax)Secondary· Day 3
PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.
Group
Value
95% CI
Plazomicin
46.6
± 43
Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin)Secondary· Day 3
PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.
Group
Value
95% CI
Plazomicin
0.88
± 95.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 32.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Plazomicin
Serious: 5/303 (2%)
Deaths: 1/303
Meropenem
Serious: 5/301 (2%)
Deaths: 0/301
Serious adverse events (12 terms)
Reaction
System
Plazomicin
Meropenem
Acute kidney injury
Renal and urinary disorders
—
—
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03270553 — A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
· Phase 1
· completed
NCT01970371 — A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (
· Phase 3
· completed
NCT01096849 — A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acu
· Phase 2
· completed
Other recruiting trials for Complicated Urinary Tract Infection
Currently open trials in the same condition.
NCT05733104 — A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
· recruiting
NCT04876131 — Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
· Phase 4
· recruiting
Other Achaogen, Inc. trials
Trials by the same sponsor.
NCT03270553 — A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
· Phase 1
· completed
NCT03177278 — A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin
· Phase 1
· completed
NCT03163550 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-3
· Phase 1
· completed
NCT01970371 — A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (
· Phase 3
· completed
NCT01096849 — A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acu
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Achaogen, Inc.
Last refreshed: 23 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02486627.