This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis

NCT07840105 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: W-6777-202
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 19

Brief Summary

This is a Phase 2 randomized open label multicentre three arm comparative study evaluating the efficacy safety tolerability and pharmacokinetics of intravenous ertapenem zidebactam ERT ZID compared with ceftazidime avibactam CAZ AVI in adults with complicated urinary tract infection cUTI or acute pyelonephritis AP. Approximately 279 hospitalized participants aged 18 years and above will be enrolled from approximately 30 study sites in India and Europe and randomized in a 1 to 1 to 1 ratio to receive ERT ZID for 5 to 7 days ERT ZID for 7 to 10 days or CAZ AVI for 7 to 10 days. The primary endpoint is overall success at Test of Cure defined by clinical cure and microbiological eradication. Secondary assessments include clinical response microbiological response by pathogen outcomes pharmacokinetic parameters and plasma protein binding with safety monitored through adverse events laboratory tests vital signs and electrocardiograms.

Conditions

Complicated Urinary Tract Infections(cUTI); Acute Pyelonephritis

Outcome Measures

Primary Outcomes (3)

• Clinical Outcome at Test of Cure (TOC) - mMITT Analysis Set:

  Clinical outcome assessed as Clinical Cure, Clinical Failure, or Clinical Indeterminate using the Daily Symptom Assessment questionnaire and Investigator assessment. Unit of measure: categorical (Clinical Cure/Clinical Failure/Clinical Indeterminate)

  Day 17 +3 days (TOC)

• Microbiological Outcome at Test of Cure (TOC) - mMITT Analysis Set

  Microbiological outcome assessed as Microbiological Eradication, Microbiological Persistence, or Microbiological Indeterminate using urine culture with species-level identification and quantitative assessment of bacterial growth. Unit of measure: categorical (Microbiological Eradication/Microbiological Persistence/Microbiological Indeterminate).

  Day 17 +3 days (TOC)

• Safety and Tolerability

  Incidence of treatment-emergent adverse events (TEAEs), drug-related TEAEs, TEAEs leading to study drug discontinuation, and serious adverse events (SAEs), and incidence of potentially clinically significant changes in laboratory parameters, vital signs, and ECG parameters. Measurement tool: adverse-event reporting, clinical laboratory tests, vital signs, and electrocardiograms. Unit of measure: number and percentage of participants.

  Day 1 to Day 26 ± 2 days

Secondary Outcomes (8)

• Clinical Response at End of Treatment (EOT) - mMITT Analysis Set

  Day 5 to 10 days +24 hours (EOT)

• Microbiological Outcome at EOT - mMITT Analysis Set

  Day 5 to 10 days +24 hours (EOT)

• By-Pathogen Overall Outcome at TOC

  Day 17 +3 days (TOC)

• By-Pathogen Microbiological Outcome at TOC

  Day 17 +3 days (TOC)

• By-Pathogen Clinical Outcome at TOC

  Day 17 +3 days (TOC)

Other Outcomes (1)

• Percentage (%) Plasma Protein Binding of ERT and ZID

  Day 1 to Day 26 ± 2 days

Study Arms (3)

Ertapenem-zidebactam

EXPERIMENTAL

Drug: Ertapenem-zidebactam

Ceftazidime-Avibactam

ACTIVE COMPARATOR

Drug: Ceftazidime-Avibactam

Ertapenem Zidebactam

EXPERIMENTAL

Drug: Ertapenam-Zidebactam

Interventions

Ertapenem-zidebactam DRUG

(2 g ERT + 2 g ZID) 4 g intravenously (IV) once daily (q24h) for 5 to 7 days

Ertapenem-zidebactam

Ceftazidime-Avibactam DRUG

(2 g ceftazidime + 0.5 g avibactam) 2.5 g IV every 8 hours (q8h) for 7 to 10 days

Ceftazidime-Avibactam

Ertapenam-Zidebactam DRUG

(2 g ERT + 2 g ZID) 4 g intravenously (IV) once daily (q24h) for 7 to 10 days

Ertapenem Zidebactam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Male or female ≥18 years of age. 2. Provide a signed written informed consent prior to any study-specific procedures.
• \. Meet the following clinical criteria for either cUTI or AP:
• A. cUTI:
• Have at least TWO of the following new-onset or worsening symptoms or signs:
• Fever (oral, tympanic, or rectal temperature \>38°C \[\>100.4°F\]), which must be observed and documented by a health care provider
• Nausea or vomiting
• Dysuria, increased urinary frequency, or urinary urgency
• Lower abdominal, suprapubic, or pelvic pain
• Have at least ONE of the following complicating factors:
• Use of intermittent urethral catheterization or presence of an indwelling urethral catheter (Note: indwelling urethral catheters that have been in place for \>24 hours prior to Screening must be removed or replaced prior to collection of the screening urine for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated)
• Current known functional or anatomical abnormality of the urogenital tract, including anatomic malformations or neurogenic bladder, or with a postvoid residual urine volume of ≥100 mL
• Complete or partial obstructive uropathy (e.g., nephrolithiasis, tumour, fibrosis, urethral stricture) that is expected to be medically or surgically treated during study drug therapy (prior to EOT)
• Azotemia, defined as blood urea nitrogen \>20 mg/dL (or blood urea \>42.8 mg/dL) or serum creatinine \>1.4 mg/dL, due to known prior intrinsic renal disease
• Documented history of urinary retention in men (e.g., previously diagnosed benign prostatic hypertrophy) B. AP: defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least
• ONE of the following new-onset or worsening symptoms or signs:

You may not qualify if:

• Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy, including but not limited to the following:
• Perinephric or renal abscess
• Uncomplicated lower UTI (e.g., cystitis)
• Recent trauma to the pelvis or urinary tract
• Polycystic kidney disease
• Chronic vesicoureteral reflux
• Previous or planned cystectomy or permanent urinary diversion (e.g., ileal loop, cutaneous ureterostomy)
• Acute or chronic bacterial prostatitis, orchitis, or epididymitis
• Concurrent non-renal source of infection (e.g., endocarditis, osteomyelitis, abscess, meningitis, pneumonia)
• Previous or planned renal transplant or trial participant requiring haemodialysis
• Where a urine culture result is available: - At least 1 uropathogen at ≥105 colony forming units per millilitre (CFU/mL) is resistant to CAZ-AVI, or - A gram-negative bacterial pathogen is not identified, or - The trial participant has a confirmed fungal cUTI with colony count ≥103 CFU/mL
• cUTI or AP that is known at Screening to be caused by a pathogen that is resistant to CAZ-AVI, including infection caused by fungi (e.g., candiduria) or mycobacteria (e.g., urogenital tuberculosis).
• Receipt of potentially effective systemic antibacterial therapy within 72 hours prior to randomization, with the exception of any of the following:
• Receipt of a single dose of an allowed short-acting antibacterial agent within 72 hours prior to randomization (see Section25.1). For trial participants without documentation of failure on this prior therapy and/or documented uropathogen resistant to this prior therapy, this exception will be capped at a maximum of 10% of enrolment.
• Receipt of \>48 hours of prior antibiotic therapy and in the investigator's opinion, failed that prior antibiotic therapy (i.e., worsening signs and symptoms).

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (19)

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

All India Institute of Medical Sciences, AIIMS, Raipur

Raipur, Chhattisgarh, 492099, India

Location

KLES Dr. Prabhakar Kore Hospital and MRC

Belagavi, Karnataka, 590010, India

Location

Mandya Institute of Medical Sciences

Mandya, Karnataka, 571401, India

Location

K R Hospital MMC and RI

Mysore, Karnataka, 570001, India

Location

Malabar Medical College

Kozhikode, Kerala, 673323, India

Location

Shravan Hospital Multispeciality and Kidney Institute Private Limited

Nagpur, Maharashtra, 440024, India

Location

Supe Heart and Diabetes Hospital and Research Centre

Nashik, Maharashtra, 422002, India

Location

Anand Multispeciality Hospital

Pune, Maharashtra, 411039, India

Location

Accord Hospital

Pune, Maharashtra, 412105, India

Location

SMS Medical College and Hospital

Jaipur, Rajasthan, 302004, India

Location

Marudhar Hospital

Jaipur, Rajasthan, 302012, India

Location

Eternal Hospital

Jaipur, Rajasthan, 302017, India

Location

VHS Infectious Diseases Medical Centre

Chennai, Tamil Nadu, 600113, India

Location

KG Hospital and Post Graduate Medical Institute & Research Centre

Coimbatore, Tamil Nadu, 641 018, India

Location

SRM Medical College Hospital and Research Centre

Kanchipuram, Tamil Nadu, 603203, India

Location

Meenakshi Mission Hospital and Research Centre

Madurai, Tamil Nadu, 625107, India

Location

Yashoda Hospital

Hyderabad, Telangana, 500003, India

Location

Medanta Hospital, Lucknow

Lucknow, Uttar Pradesh, 226030, India

Location

MeSH Terms

Interventions

avibactam, ceftazidime drug combination

Central Study Contacts

Ranjeet Gutte Vice President, Global Clinical Development

CONTACT

9819858489; rgutte@wockhardt.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 24, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

IN (19)