Clinical trials: Urinary Tract Infection (cUTI)
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
Complicated Urinary Tract Infection
A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI
This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for…
- Trial name
- NCT05826990
- Testing
- cefepime and enmetazobactam combination
- Where
- 8 sites in Czechia, France and 4 more
- Volunteers
- 40 people
- Sponsor
- Orchid Pharma Europe GmbH
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)
Complicated Urinary Tract Infection, Acute Pyelonephritis
Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract…
- Trial name
- ADAPT-PO (NCT03788967)
- Testing
- TBPM-PI-HBr, Ertapenem, Dummy Infusion
- Where
- 96 sites in United States, Bulgaria and 13 more
- Volunteers
- 1,372 people
- Sponsor
- Spero Therapeutics
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 Infection, Acute Pyelonephritis
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication)…
- Trial name
- PIVOT-PO (NCT06059846)
- Testing
- TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion
- Where
- 85 sites in United States, Argentina and 17 more
- Volunteers
- 1,690 people
- Sponsor
- Spero Therapeutics
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.
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
Complicated Urinary Tract Infection, Pyelonephritis
MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.
- Trial name
- NCT03230838
- Testing
- Ceftolozane/Tazobactam, Meropenem
- Where
- 52 sites in United States, Greece and 8 more
- Volunteers
- 134 people
- Sponsor
- Merck Sharp & Dohme LLC
Complicated Urinary Tract Infection, Pyelonephritis
Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including…
- Trial name
- NCT01345929
- Testing
- CXA-201, Levofloxacin
- Where
- 76 sites in United States, Brazil and 15 more
- Volunteers
- 558 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Complicated Urinary Tract Infection; Cuti
Pharmacokinetics of Benapenem in Subjects With Renal Impairment
This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects.
- Trial name
- NCT04476407
- Testing
- benapenem
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
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
Urinary Tract Infection Complicated, Acute Pyelonephritis
Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).
- Trial name
- NCT02166476
- Testing
- Meropenem-Vaborbactam, Piperacillin-Tazobactam, Levofloxacin
- Where
- 77 sites in United States, Belarus and 15 more
- Volunteers
- 550 people
- Sponsor
- Melinta Therapeutics, Inc.
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 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 Including Acute Pyelonephritis
Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40)
This is A Multicenter, Randomized, Double-Blind, Double-Dummy, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/Funobactam in Comparison with Meropenem in Hospitalized Adults with…
- Trial name
- NCT05204368
- Testing
- Combination of Imipenem/Cilastatin and XNW4107, Meropenem
- Where
- United States
- Volunteers
- 780 people
- Sponsor
- Evopoint Biosciences Inc.
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.
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