Phase 3
N=609
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
Complicated Urinary Tract Infection · Acute Pyelonephritis
Bottom Line
View on ClinicalTrials.gov: NCT02486627 ↗Enrolled (actual)
609
Serious AEs
1.7%
Results posted
Aug 2018
Primary outcome: Primary: Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 — 88; 91.4; 10.5; 7.6 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- plazomicin (Drug); meropenem (Drug); levofloxacin (oral) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Achaogen, Inc.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5 |
88; 91.4; 10.5; 7.6; 1.6; 1 | — |
| PRIMARY Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC) |
81.7; 70.1; 15.2; 25.9; 3.1; 4.1 | — |
| SECONDARY Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at Day 5 |
89.4; 94.2; 10.6; 5.8 | — |
| SECONDARY Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at TOC |
84.9; 75.1; 15.1; 24.9 | — |
| SECONDARY Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) |
19.5; 21.6 | — |
| SECONDARY Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0-24h) |
234 | — |
| SECONDARY Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax) |
46.6 | — |
| SECONDARY Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin) |
0.88 | — |
Summary
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.
Eligibility Criteria
Key Inclusion Criteria
- Pyuria
- Have a pretreatment baseline urine culture obtained within 36 hours before the start of administration of the first dose of study drug
- Clinical signs and/or symptoms of acute pyelonephritis or complicated urinary tract infection
- Normal renal function or moderate renal impairment
Key Exclusion Criteria
- Confirmed fungal urinary tract infection at the time of randomization
- Known urinary tract infection or colonization with Gram-positive pathogens
- Current cUTI or AP is known to be caused by a pathogen resistant to meropenem
- Female participants of childbearing potential if they are known to be pregnant or have a positive pregnancy test at screening, breastfeeding, or unable or unwilling to use a highly effective method of birth control during the study and for at least 30 days following the last dose of study medication
- Any rapidly progressing disease or immediately life-threatening illness
- Documented presence of immunodeficiency or an immunocompromised condition
- Documented or known history of otologic surgery or disease including use of hearing aid, head injury leading to otologic damage, Ménière's disease, tumor of the head, neck, or auditory system, perilymphatic fistula, or autoimmune disease of the inner ear, or family history of hearing loss (excluding age-related hearing loss [onset after age of 65 years])
Data sourced from ClinicalTrials.gov (NCT02486627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.