Complicated Urinary Tract Infections(cUTI)Phase 2NCT07840105
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
A Phase 2 study testing Ertapenem-zidebactam, Ceftazidime-Avibactam and Ertapenam-Zidebactam in people with Complicated Urinary Tract Infections(cUTI) and Acute Pyelonephritis, run by Wockhardt at 19 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complicated Urinary Tract Infections(cUTI), Acute Pyelonephritis
- What is being tested?
- Ertapenem-zidebactam, Ceftazidime-Avibactam and Ertapenam-Zidebactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 19 sitesIndia
- Study dates
- 30 Sep 2026to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female ≥18 years of age. 2. Provide a signed written informed consent prior to any study-specific procedures.
- 3. Meet the following clinical criteria for either cUTI or AP:
- 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
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- 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:
- 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 Note: If criteria for both cUTI and AP are met, AP will be considered the study entry diagnosis for randomization and analysis purposes. 4. Evidence of pyuria within 48 hours prior to randomization, as determined by an adequate midstream clean-catch urine specimen or other appropriate method that minimizes the risk of bacterial contamination with ONE of the following findings:
- Positive leukocyte esterase on urinalysis, (where positive result is at least "++" or moderate as indicated on a urine dipstick)
- White blood cell (WBC) count ≥10 cells/mm3 in unspun urine -WBC count ≥10 cells/high-power field in urine sediment (spun urine) Note: The screening/baseline urine sample (within 48 hours prior to randomization) will be submitted for culture; however, trial participants may be randomized and administered study drug therapy prior to knowledge of screening/baseline urine culture results. 5. If known, the screening/baseline urine culture taken within 48 hours prior to randomization contains ≥105 colony forming units (CFU)/mL of a gram negative uropathogen likely to be susceptible to CAZ-AVI.
- 6. Expectation, in the judgment of the investigator, that any implanted urinary instrumentation (e.g., nephrostomy tubes, ureteric stents) will be surgically removed or replaced before randomization or within 24 hours after randomization, unless removal or replacement is considered unsafe or contraindicated; note that temporary 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 sample for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated.
- Note: Urinary stone(s) (nephrolithiasis) present at Screening are also considered a removable source of infection.
- 7. Requires hospitalization with administration of parenteral antibiotic therapy to manage the cUTI or AP in accordance with standard of care.
- 8. All females (except those who have a documented surgical sterilization or are postmenopausal as defined below) must have a negative urine or serum pregnancy test (beta-human chorionic gonadotropin [β-HCG]) at Screening
- AND agree to the use of one of the following highly effective methods of contraception from Screening through TOC:
- Surgical sterilization (defined as bilateral oophorectomy or bilateral salpingectomy, but excluding bilateral tubal occlusion)
- Postmenopausal (defined by amenorrhea for at least 24 months following cessation of all exogenous hormonal treatments)
- Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
- Intrauterine device
- Intrauterine hormone-releasing system
- Sexual intercourse with only vasectomized partners, or
- Abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the trial participant Note: A serum or urine pregnancy test will be performed at Screening for all female participants except those who are documented postmenopausal or surgically sterile.
- A negative result is required to confirm eligibility. All males must agree to use an acceptable barrier method of birth control (i.e., condom) with female partner(s) and must not donate sperm from Screening through TOC.
Who cannot join
- 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
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- 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).
- Documented to have cUTI or AP caused by a pathogen that is not susceptible to the prior antibiotic therapy.
- Trial participants who may need ongoing antibacterial drug prophylaxis after treatment of cUTI (such as vesico-ureteral reflux etc).
- Confirmed or clinical suspicion of CAZ-AVI resistance.
- History of previous exposure to CAZ-AVI treatment (full course of treatment) in the last 90 days prior to randomization
- Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the trial participant is unlikely to survive the study period.
- Pregnant or breastfeeding women.
- Likely to require >10 days of antibiotic treatment to cure the current acute cUTI or AP, or likely to receive any additional systemic antimicrobial therapy during the study period (including antibacterial, antimycobacterial, or antifungal therapy or prophylaxis) other than study drug, with the exception of (1) a single oral dose of any antifungal treatment for vaginal candidiasis, or (2) a glycopeptide (e.g., vancomycin), oxazolidinone (e.g., linezolid), or daptomycin given for a gram-positive infection.
- Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy).
- History of epilepsy or known seizure disorder requiring current treatment with anti-seizure medication, or confirmed or suspected encephalopathy (e.g., myoclonus, altered mental status, depressed level of consciousness).
- Trial participant requires concomitant treatment with valproic acid, divalproex, or probenecid.
- CrCl <30 mL/min or requirement for haemodialysis or CVVH
- Current or anticipated neutropenia defined as <500 neutrophils/mm3, or platelet count <50,000 per microliter.
- Screening serum total bilirubin ≥2 times the upper limit of normal (ULN) (unless elevated indirect bilirubin due to known Gilbert's syndrome), alanine aminotransferase ≥5 × ULN (or aspartate aminotransferase ≥5 × ULN if alanine aminotransferase activity not available), or alkaline phosphatase ≥2 × ULN.
- History of Clostridioides difficile-associated disease within 6 months prior to enrolment.
- History of serious or significant hypersensitivity or allergic reaction (e.g., anaphylaxis, urticaria, other significant reaction) to any β-lactam antibiotic.
- Prior receipt of ERT-ZID, prior randomization in this study, or use of any experimental drug or device within 30 days prior to enrolment.
- Unlikely to comply with the protocol (e.g., inability to return for all study visits), or any condition (including social circumstances) or clinically significant abnormality that, in the opinion of the investigator, is likely to interfere with optimal study participation (e.g., evaluation of study drug efficacy, determination of safety, or completion of the expected course of treatment).
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
India19 sites
KLES Dr. Prabhakar Kore Hospital and MRC
Belagavi, Karnataka, 590010
Dr Vikram Prabha, 9886117850, dr.vikram.prabha@gmail.com
VHS Infectious Diseases Medical Centre
Chennai, Tamil Nadu, 600113
Dr N Kumarasamy, 9176912007, drkumarasamy74@gmail.com
KG Hospital and Post Graduate Medical Institute & Research Centre
Coimbatore, Tamil Nadu, 641 018
Dr Ramaswami Sethuraman, 9600900078, ramaswamy.sethuraman@gmail.com
Yashoda Hospital
Hyderabad, Telangana, 500003
Dr V Suresh Babu, 9849304805, sukonda2007@gmail.com
SMS Medical College and Hospital
Jaipur, Rajasthan, 302004
Dr Dhananjai Agrawal, 9414459790, dhananjaynephro@gmail.com
Marudhar Hospital
Jaipur, Rajasthan, 302012
Dr Bhanu Kaushik, 9413473986, bhanukaushik4@gmail.com
Eternal Hospital
Jaipur, Rajasthan, 302017
Dr Ashok Kumar Sharma, 9829065210, draksharma_50@yahoo.com
SRM Medical College Hospital and Research Centre
Kanchipuram, Tamil Nadu, 603203
Dr T Senthil Kumar, 9444226422, senthilt4@srmist.edu.in
Malabar Medical College
Kozhikode, Kerala, 673323
Dr Sanju Rajappan, 9778425563, drsanju002@gmail.com
Medanta Hospital, Lucknow
Lucknow, Uttar Pradesh, 226030
Dr Raj Kumar Sharma, 9415026762, rksnepho206@gmail.com
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, 625107
Dr Sampathkumar Krishnaswamy, 9994872250, drksampath@gmail.com
Mandya Institute of Medical Sciences
Mandya, Karnataka, 571401
Dr Rekha M C, 9845343736, rekhamc73@gmail.com
K R Hospital MMC and RI
Mysore, Karnataka, 570001
Dr Niranjan MR, 9448672501, drniranjanmr@gmail.com
Shravan Hospital Multispeciality and Kidney Institute Private Limited
Nagpur, Maharashtra, 440024
Dr Prakash Khetan, 9823071748, prakashkhe@gmail.com
Supe Heart and Diabetes Hospital and Research Centre
Nashik, Maharashtra, 422002
Dr Pratikhit Madhav Mahajan, 9881058580, pratikshitm23@gmail.com
Anand Multispeciality Hospital
Pune, Maharashtra, 411039
Dr Upendra Kudlikar, 7030729676, upendra31jul@rediffmail.com
Accord Hospital
Pune, Maharashtra, 412105
Dr Ramshyam Agarwal, 8087282022, ramshyamagarwal20@gmail.com
All India Institute of Medical Sciences, AIIMS, Raipur
Raipur, Chhattisgarh, 492099
Dr Amit Sharma, 8691898668, dramiturology@gmail.com
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
Dr Vijaya Kumar, 9959320268, drvijayakumarresearch8@gmail.com
About this study
Official title: A Phase 2, Randomized, Open-Label, Multicentre, Comparative 3 Arm Study to Evaluate the Efficacy And Safety of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
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.
- Being tested
- Ertapenem-zidebactam, Ceftazidime-Avibactam, Ertapenam-Zidebactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ertapenem-zidebactamDrug
(2 g ERT + 2 g ZID) 4 g intravenously (IV) once daily (q24h) for 5 to 7 days
Ceftazidime-AvibactamDrug
(2 g ceftazidime + 0.5 g avibactam) 2.5 g IV every 8 hours (q8h) for 7 to 10 days
Ertapenam-ZidebactamDrug
(2 g ERT + 2 g ZID) 4 g intravenously (IV) once daily (q24h) for 7 to 10 days
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem-zidebactam | Experimental | Not described Receives: Drug: Ertapenem-zidebactam |
| Ceftazidime-Avibactam | Active comparator | Not described Receives: Drug: Ceftazidime-Avibactam |
| Ertapenem Zidebactam | Experimental | Not described Receives: Drug: Ertapenam-Zidebactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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.
Measured: Day 1 to Day 26 ± 2 days
Secondary outcomes (8)
Clinical Response at End of Treatment (EOT) - mMITT Analysis Set
Clinical response assessed as Clinical Response, Clinical Non-response, or Clinical Indeterminate using the Daily Symptom Assessment questionnaire and Investigator assessment. Unit of measure: categorical (Clinical Response/Clinical Non-response/Clinical Indeterminate).
Measured: Day 5 to 10 days +24 hours (EOT)
Microbiological Outcome at EOT - 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)
Measured: Day 5 to 10 days +24 hours (EOT)
By-Pathogen Overall Outcome at TOC
Overall outcome for each baseline uropathogen, based on the corresponding clinical and microbiological outcomes. Unit of measure: categorical (Overall Success/Overall Failure/Overall Indeterminate). Measurement tools: Daily Symptom Assessment questionnaire and Investigator assessment, and urine culture.
Measured: Day 17 +3 days (TOC)
By-Pathogen Microbiological Outcome at TOC
Microbiological outcome for each baseline uropathogen assessed using urine culture with species-level identification and quantitative assessment of bacterial growth. Unit of measure: categorical (Microbiological Eradication/Microbiological Persistence/Microbiological Indeterminate)
Measured: Day 17 +3 days (TOC)
By-Pathogen Clinical Outcome at TOC
Clinical outcome for each baseline uropathogen assessed using the Daily Symptom Assessment questionnaire and Investigator assessment. Unit of measure: categorical (Clinical Cure/Clinical Failure/Clinical Indeterminate)
Measured: Day 17 +3 days (TOC)
Maximum Plasma Concentration (Cmax) of ERT-ZID
Maximum plasma concentration of ertapenem-zidebactam measured from plasma PK samples. Unit of measure: concentration x time (15 min, between 1 to 2 hrs, between 5 to 7 hrs, between 9 to 11 hrs, between 20 to 23 hrs from the infusion of drug).
Measured: During the treatment period according to scheduled PK sampling on Day 1, Day 3 and Day 4.
AUC0-t of ERT-ZID
Area under the plasma concentration-time curve of ertapenem-zidebactam from time 0 to the last quantifiable concentration. Unit of measure: concentration × time (15 min, between 1 to 2 hrs, between 5 to 7 hrs, between 9 to 11 hrs, between 20 to 23 hrs from the infusion of drug).
Measured: During the treatment period according to scheduled PK sampling on Day 1, Day 3 and Day 4
AUC0-inf of ERT-ZID
Area under the plasma concentration-time curve of ertapenem-zidebactam from time 0 to infinity. Unit of measure: concentration × time (15 min, between 1 to 2 hrs, between 5 to 7 hrs, between 9 to 11 hrs, between 20 to 23 hrs from the infusion of drug).
Measured: During the treatment period according to scheduled PK sampling on Day 1, Day 3 and Day 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract Infections(cUTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840105
- Sponsor's protocol ID
- W-6777-202
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Multicentre, Comparative 3 Arm Study to Evaluate the Efficacy And Safety of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
- ClinicalTrials.gov ID
- NCT07840105
- Acronym / sponsor ID
- W-6777-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ertapenem-zidebactam | Experimental | Drug: Ertapenem-zidebactam |
| Ceftazidime-Avibactam | Active comparator | Drug: Ceftazidime-Avibactam |
| Ertapenem Zidebactam | Experimental | Drug: Ertapenam-Zidebactam |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 1. Male or female ≥18 years of age. 2. Provide a signed written informed consent prior to any study-specific procedures.
- cUTI:
- Have at least TWO of the following new-onset or worsening symptoms or signs:
- Have at least ONE of the following complicating factors:
- 6. Expectation, in the judgment of the investigator, that any implanted urinary instrumentation (e.g., nephrostomy tubes, ureteric stents) will be surgically removed or replaced before randomization or within 24 hours after randomization, unless removal or replacement is considered unsafe or contraindicated; note that temporary 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 sample for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated.
Key exclusion criteria (32 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ertapenem-zidebactam(2 g ERT + 2 g ZID) 4 g intravenously (IV) once daily (q24h) for 5 to 7 days | Drug | Ertapenem-zidebactam |
| Ceftazidime-Avibactam(2 g ceftazidime + 0.5 g avibactam) 2.5 g IV every 8 hours (q8h) for 7 to 10 days | Drug | Ceftazidime-Avibactam |
| Ertapenam-Zidebactam(2 g ERT + 2 g ZID) 4 g intravenously (IV) once daily (q24h) for 7 to 10 days | Drug | Ertapenem Zidebactam |
Primary outcome
Clinical Outcome at Test of Cure (TOC) - mMITT Analysis Set:
Time frame: Day 17 +3 days (TOC)
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)
Microbiological Outcome at Test of Cure (TOC) - mMITT Analysis Set
Time frame: Day 17 +3 days (TOC)
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).
Safety and Tolerability
Time frame: Day 1 to Day 26 ± 2 days
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.
8 secondary outcomes
Clinical Response at End of Treatment (EOT) - mMITT Analysis Set
Time frame: Day 5 to 10 days +24 hours (EOT)
Microbiological Outcome at EOT - mMITT Analysis Set
Time frame: Day 5 to 10 days +24 hours (EOT)
By-Pathogen Overall Outcome at TOC
Time frame: Day 17 +3 days (TOC)
By-Pathogen Microbiological Outcome at TOC
Time frame: Day 17 +3 days (TOC)
By-Pathogen Clinical Outcome at TOC
Time frame: Day 17 +3 days (TOC)
Maximum Plasma Concentration (Cmax) of ERT-ZID
Time frame: During the treatment period according to scheduled PK sampling on Day 1, Day 3 and Day 4.
AUC0-t of ERT-ZID
Time frame: During the treatment period according to scheduled PK sampling on Day 1, Day 3 and Day 4
AUC0-inf of ERT-ZID
Time frame: During the treatment period according to scheduled PK sampling on Day 1, Day 3 and Day 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ertapenem-zidebactam, Ceftazidime-Avibactam and Ertapenam-Zidebactam in people with Complicated Urinary Tract Infections(cUTI) and Acute Pyelonephritis, run by Wockhardt at 19 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ranjeet Gutte Vice President, Global Clinical Development (9819858489, rgutte@wockhardt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome at Test of Cure (TOC) - mMITT Analysis Set: (time frame: Day 17 +3 days (TOC)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.