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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefepime-zidebactam (FEP-ZID) | Experimental |
| |
| Meropenem | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefepime-zidebactam (FEP-ZID) | Drug | 3 g (2 g FEP + 1 g ZID) IV q8h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Overall Success at Test-of-Cure | Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 colony forming units or CFU/mL) | Test Of Cure Visit (Day 17 ± 2 days) |
| Percentage of Subjects With Treatment-Emergent Adverse Events (TEAE) | Collection of number of adverse events. | Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Overall Success at End-of-Treatment | Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (<1000 CFU/mL) | End of Treatment Visit (Day 7 - 10 ± 1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S&D Clinical Research, LLC | Fort Myers | Florida | 33919 | United States | ||
| Santos Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cefepime-zidebactam (FEP-ZID) | Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h |
| FG001 | Meropenem | Meropenem: 1 g IV q8h |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2021 | Jan 12, 2026 |
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| Meropenem |
| Drug |
1 g IV q8h |
|
| Percentage of Subjects With Clinical Cure at End-of-Treatment | Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL)(CFU)/mL. | End of Treatment Visit (Day 7 - 10 ± 1 day) |
| Percent of Subjects With Microbiological Eradication at End-of-Treatment | Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial pathogen found at study entry | End of Treatment Visit (Day 7 - 10 ± 1 day) |
| Percentage of Subjects With Clinical Cure at Test-of-Cure | Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL) | Test-of-Cure (Day 17+-2) |
| Percent of Subjects With Microbiological Eradication at Test-of-Cure | Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial | Test-of-Cure (Day 17 ± 2 days) |
| Percentage of Subjects With Clinical Cure at Late Follow-up | Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL) | Late Follow-up (Day 26 ± 2 days) |
| Plasma Concentration of FEP-ZID | Plasma samples from ZID-FEP-treated subjects were analyzed to determine concentrations of ZID and FEP using a validated assay. Pharmacokinetic analyses were based on the PK populations at pre-specified time points on Days 1 and 3 (+1). | On Days 1 and 3 (+1) of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion |
| Tampa |
| Florida |
| 33615 |
| United States |
| MHAT Dobrich AD | Dobrich | Bulgaria |
| UMHAT Dr. Georgi Stranski | Pleven | Bulgaria |
| Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv | Plovdiv | Bulgaria |
| Multiprofile Hospital for Active Treatment - KANEV | Rousse | Bulgaria |
| Multiprofile Hospital for Active Treatment (MHAT)- Silistra | Silistra | Bulgaria |
| Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD | Sofia | Bulgaria |
| Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov | Sofia | Bulgaria |
| UMHAT Aleksandrovska Sofia - Clinic of Urology, Clinic of Anaesthesiology and Intensive Care, Clinic of Clinical Hematology | Sofia | Bulgaria |
| Multiprofile Hospital for Active Treatment (MHAT) Sveta Anna - Varna | Varna | Bulgaria |
| Hunan Provincial People's Hospital | Changsha | China |
| The Second Xiangya Hospital of Central South University | Changsha | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | 400010 | China |
| Deyang People's Hospital | Deyang | China |
| General hospital of the PLA northern theater command | Liaoyang | China |
| Fudan University Huashan Hospital | Shanghai | 200040 | China |
| Shaoxing People's Hospital | Shaoxing | China |
| Ida-Viru Central Hospital | Kohtla-Järve | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | Estonia |
| West Tallinn Central Hospital | Tallinn | Estonia |
| Tartu University Hospital | Tartu | Estonia |
| South-Estonian Hospital Ltd. | Võru | Estonia |
| Super Speciality Hospital Government Medical College and Hospital | Aurangabad | Maharashtra | 431004 | India |
| Supe Hearth & Diabetes Hospital & Research Centre | Nashik | Maharashtra | 422002 | India |
| ACE Hospital and Research Centre | Pune | Maharashtra | 411004 | India |
| Accord Hospitals | Pune | Maharashtra | 412105 | India |
| Aartham Multi Super Speciality Hospital | Ahmedabad | 380006 | India |
| ORIION Citicare Super Speciality Hospital | Aurangabad | 431005 | India |
| Klaipedos university hospital | Klaipėda | LT-92288 | Lithuania |
| Republican Vilnius University hospital | Vilnius | Lithuania |
| Vilnius city clinical hospital | Vilnius | Lithuania |
| Vilnius University Hospital Santaros Klinikos | Vilnius | Lithuania |
| Hospital Angeles Chihuahua | Chihuahua City | 31238 | Mexico |
| JM Research Cuernavaca | Cuernavaca | 62290 | Mexico |
| Centro de Investigacion Clinica de Oaxaca (CICLO) | Oaxaca City | Mexico |
| Pharmacology & Clinical Research | Querétaro | Mexico |
| Arke SMO S.A. de C.V. | Veracruz | Mexico |
| Unidad de Atención Médica e Investigación en Salud (Unamis) | Yucatán | C.P 97000 | Mexico |
| Zespol Opieki Zdrowotnej w Boleslawcu | Bolesławiec | Poland |
| SCM Sp. z o.o. | Krakow | 31-559 | Poland |
| Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii | Lodz | 90-153 | Poland |
| Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Chorob Wewnetrznych, Nefrologii i Dializoterapii | Warsaw | Poland |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica | Banská Bystrica | Slovakia |
| Fakultna nemocnica Nitra | Nitra | Slovakia |
| Nemocnica Poprad, a.s. Urologicke oddeleni | Poprad | Slovakia |
| Fakultna nemocnica s poliklinikou Zilina | Žilina | Slovakia |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Analysis Population described here includes MITT (modified intend to treat)
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| ID | Title | Description |
|---|---|---|
| BG000 | Cefepime-zidebactam (FEP-ZID) | Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h |
| BG001 | Meropenem | Meropenem: 1 g IV q8h |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Overall Success at Test-of-Cure | Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 colony forming units or CFU/mL) | Overall outcome in mMITT-STIC Population | Posted | Count of Participants | Participants | Test Of Cure Visit (Day 17 ± 2 days) |
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| Primary | Percentage of Subjects With Treatment-Emergent Adverse Events (TEAE) | Collection of number of adverse events. | Safety Population | Posted | Count of Participants | Participants | Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)] |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Overall Success at End-of-Treatment | Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (<1000 CFU/mL) | Overall Outcome at End of Treatment (EOT) (mMITT-STIC Population) | Posted | Count of Participants | Participants | End of Treatment Visit (Day 7 - 10 ± 1 day) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Clinical Cure at End-of-Treatment | Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL)(CFU)/mL. | Clinical Outcome at End of Treatment (EOT) (mMITT-STIC Population) | Posted | Count of Participants | Participants | End of Treatment Visit (Day 7 - 10 ± 1 day) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Microbiological Eradication at End-of-Treatment | Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial pathogen found at study entry | Microbiological Outcome at End of Treatment (EOT) (mMITT-STIC population) | Posted | Count of Participants | Participants | End of Treatment Visit (Day 7 - 10 ± 1 day) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Clinical Cure at Test-of-Cure | Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL) | Clinical Outcome at Test of Cure (TOC)(mMITT-STIC) | Posted | Count of Participants | Participants | Test-of-Cure (Day 17+-2) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Microbiological Eradication at Test-of-Cure | Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial | Microbiologic eradication at Test of Cure (TOC) (mMITT-STIC population) | Posted | Count of Participants | Participants | Test-of-Cure (Day 17 ± 2 days) |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Clinical Cure at Late Follow-up | Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL) | Clinical outcome at Late Follow-up (LFU) in mMITT-STIC population | Posted | Count of Participants | Participants | Late Follow-up (Day 26 ± 2 days) |
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| Secondary | Plasma Concentration of FEP-ZID | Plasma samples from ZID-FEP-treated subjects were analyzed to determine concentrations of ZID and FEP using a validated assay. Pharmacokinetic analyses were based on the PK populations at pre-specified time points on Days 1 and 3 (+1). | Pharmacokinetic Evaluation in adult subjects with cUTI or AP | Posted | Mean | Standard Deviation | ug/mL | On Days 1 and 3 (+1) of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion |
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Through study completion, from the signing of the Informed Consent Form (ICF) to the Late Follow-Up (LFU) visit, approximately 28 days per participant.
TEAEs were assessed in all participants who received at least one dose of study drug (FEP-ZID: 352; Meropenem: 177). A TEAE is defined as any AE occurring after first dose through the LFU visit (Day 26 ± 2 days). All-cause mortality was monitored per protocol; any death within 30 days after last contact was required to be reported. No deaths were observed in either arm during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cefepime-zidebactam (FEP-ZID) | Cefepime-zidebactam (FEP-ZID): 3 g (2 g FEP + 1 g ZID) IV q8h | 0 | 352 | 8 | 352 | 35 | 352 |
| EG001 | Meropenem | Meropenem: 1 g IV q8h | 0 | 177 | 1 | 177 | 19 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mechanical ileus | Gastrointestinal disorders | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
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| Pseudomembranous colitis | Infections and infestations | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Urethral stenosis | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERTENTION | Cardiac disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nazimuddin Chishti | Wockhardt Bio AG | 02406694353 | NChishti@wockhardt.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2024 | Jan 12, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000624485 | cefepime-zidebactam |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Asian Non Chinese |
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| Asian Chinese |
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| American Indianor Alaskan Native |
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| China |
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| Poland |
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| Mexico |
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| Slovakia |
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| Bulgaria |
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| Lithuania |
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| Estonia |
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| India |
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