Clinical trials: Complicated Urinary Tract Infections(cUTI)
Complicated Urinary Tract Infection, Acute Pyelonephritis
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
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.
- Trial name
- NCT04979806
- Testing
- Cefepime-zidebactam (FEP-ZID), Meropenem
- Where
- 48 sites in United States, Bulgaria and 7 more
- Volunteers
- 530 people
- Sponsor
- Wockhardt
Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with…
- Conditions
- Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)
- Trial name
- NCT04215991
- Testing
- Cefiderocol, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 91 people
- Sponsor
- Shionogi
Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
The purpose of this study is to evaluate the efficacy and safety of HRS-8427 in patients with complicated urinary tract infection, including acute pyelonephritis.
- Trial name
- NCT06569056
- Testing
- HRS-8427, Imipenem and Cilastatin Sodium
- Where
- China
- Volunteers
- 579 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Urinary Tract Infections, Acute Pyelonephritis
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.
- Trial name
- CERTAIN-1 (NCT03840148)
- Testing
- Cefepime/VNRX-5133 (taniborbactam), Meropenem
- Where
- 78 sites in United States, Argentina and 13 more
- Volunteers
- 661 people
- Sponsor
- Venatorx Pharmaceuticals, Inc.
Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI)
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
- Conditions
- Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI)
- Trial name
- CREDIBLE - CR (NCT02714595)
- Testing
- Cefiderocol, Best Available Therapy
- Where
- 85 sites in United States, Brazil and 14 more
- Volunteers
- 152 people
- Sponsor
- Shionogi
Complicated Urinary Tract Infection, Acute Pyelonephritis
Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
This is a Phase III, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-TAZ vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
- Trial name
- NCT03630081
- Testing
- WCK 4282 (FEP-TAZ) 4 g, Meropenem, ciprofloxacin 500 mg Optional Oral Switch
- Volunteers
- 1,004 people
- Sponsor
- Wockhardt
Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI)
Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.
Complicated urinary tract infections (cUTIs) often lead to the overuse of empiric antibiotics, risking inappropriate treatment and contributing to antimicrobial resistance.
- Conditions
- Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI), Urinary Tract Infection (Diagnosis)
- Trial name
- PCR (NCT06996301)
- Testing
- Treatment guided by the PCR results, Treatment guided by the C&S results
- Where
- 6 sites in United States
- Volunteers
- 773 people
- Sponsor
- Doc Lab Inc
Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
A Trial of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS -8427 in patients with complicated urinary tract infection, including acute pyelonephritis.
- Trial name
- NCT06144060
- Testing
- HRS -8427, Imipenem and Cilastatin Sodium
- Volunteers
- 126 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Complicated Urinary Tract Infections(cUTI)
Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
- Trial name
- NCT07719257
- Testing
- TUL108
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Complicated Urinary Tract Infection, Acute Pyelonephritis
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated…
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis, cUTI, AP
- Trial name
- Integral-1 (NCT05887908)
- Testing
- co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, imipenem/cilastatin
- Where
- 61 sites in Bulgaria, China and 7 more
- Volunteers
- 614 people
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection
Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) in Japanese Participants With Complicated Intra-abdominal Infection or Complicated Urinary Tract Infection (MK-7655A-017)
The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL, MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI).
- Trial name
- NCT03293485
- Testing
- Imipenem+Cilastatin/Relebactam
- Where
- 29 sites in Japan
- Volunteers
- 83 people
- Sponsor
- Merck Sharp & Dohme LLC
Complicated Urinary Tract Infections
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
- Trial name
- NCT03377426
- Testing
- LYS228, Standard of care therapy
- Where
- 5 sites in United States, Denmark and 1 more
- Sponsor
- Novartis Pharmaceuticals
Complicated Urinary Tract Infection, Acute Pyelonephritis
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary…
- Trial name
- NCT01096849
- Testing
- levofloxacin, plazomicin
- Volunteers
- 145 people
- Sponsor
- Achaogen, Inc.
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI)
- Trial name
- NCT07089186
- Testing
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Complicated Urinary Tract Infection, Acute Pyelonephritis
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
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…
- Trial name
- EPIC (NCT02486627)
- Testing
- plazomicin, meropenem, levofloxacin (oral)
- Volunteers
- 609 people
- Sponsor
- Achaogen, Inc.
Complicated Urinary Tract Infection
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Performance evaluation of QIAstat-Dx cUTI Plus AMR Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user…
- Trial name
- NCT06824129
- Where
- United Kingdom
- Volunteers
- 1,500 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Complicated Urinary Tract Infections(cUTI), Acute Pyelonephritis
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
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…
- Trial name
- NCT07840105
- Testing
- Ertapenem-zidebactam, Ceftazidime-Avibactam, Ertapenam-Zidebactam
- Where
- 19 sites in India
- Volunteers
- 279 people
- Sponsor
- Wockhardt
Urinary Tract Infections
POS-cUTI: Study on Complicated Urinary Tract Infections
Urinary tract infections (UTI) are among the most common infectious diseases and the most frequent source of community, healthcare-associated and nosocomial bacteraemia.
- Trial name
- NCT05458700
- Testing
- Collect information
- Where
- Spain
- Volunteers
- 16,000 people
- Sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
Urinary Tract Infection Symptomatic, Acute Pyelonephritis
Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections
The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of…
- Conditions
- Urinary Tract Infection Symptomatic, Acute Pyelonephritis, Urinary Tract Infection Complicated
- Trial name
- ZEUS (NCT02753946)
- Testing
- ZTI-01, Piperacillin-tazobactam
- Where
- 68 sites in United States, Belarus and 14 more
- Volunteers
- 465 people
- Sponsor
- Nabriva Therapeutics AG