A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

NCT ID: NCT02486627

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 609 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-11
• Study Completion Date: 2016-09-22

Brief 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.

Conditions

Complicated Urinary Tract Infection; Acute Pyelonephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Plazomicin

Patients received 15 milligrams per kilogram (mg/kg) plazomicin as an intravenous (IV) infusion once daily followed by matching placebo infusions 8 and 16 hours later. After a minimum of 4 days of IV plazomicin, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).

Group Type: EXPERIMENTAL

plazomicin

Intervention Type: DRUG

levofloxacin (oral)

Intervention Type: DRUG

Meropenem

Patients received 1.0 g meropenem as an IV infusion every 8 hours (q8h). After a minimum of 4 days of IV meropenem, patients could switch to 250 or 500 mg oral levofloxacin for a total duration of 7 to 10 days (IV plus oral).

Group Type: ACTIVE_COMPARATOR

meropenem

Intervention Type: DRUG

levofloxacin (oral)

Intervention Type: DRUG

Interventions

plazomicin

Intervention Type: DRUG

meropenem

Intervention Type: DRUG

levofloxacin (oral)

Intervention Type: DRUG

Eligibility Criteria

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

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])

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Achaogen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn E Connolly, MD, PhD

Role: STUDY_DIRECTOR

Achaogen, Inc.

References

Wagenlehner FME, Cloutier DJ, Komirenko AS, Cebrik DS, Krause KM, Keepers TR, Connolly LE, Miller LG, Friedland I, Dwyer JP; EPIC Study Group. Once-Daily Plazomicin for Complicated Urinary Tract Infections. N Engl J Med. 2019 Feb 21;380(8):729-740. doi: 10.1056/NEJMoa1801467.

Reference Type: DERIVED

PMID: 30786187 (View on PubMed)

Other Identifiers

2015-001588-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1171-1554

Identifier Type: OTHER

Identifier Source: secondary_id

ACHN-490-009

Identifier Type: -

Identifier Source: org_study_id