Clinical trials: Complicated Urinary Tract Infection (cUTI)
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
Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and
Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With cUTI, cIAI,NP Including VAP
Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including…
- Conditions
- Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and, Nosocomial Pneumonia (NP)
- Trial name
- RECOMMEND (NCT02364284)
- Where
- 27 sites in Brazil, France and 4 more
- Volunteers
- 1,322 people
- Sponsor
- Pfizer
Complicated Urinary Tract Infection Including Acute Pyelonephritis
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- Trial name
- NCT04505683
- Testing
- Benapenem, Ertapenem
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
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
cUTI
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections…
- Trial name
- NCT01978938
- Testing
- Eravacycline, Levofloxacin
- Where
- 99 sites in United States, Bulgaria and 16 more
- Volunteers
- 908 people
- Sponsor
- Tetraphase 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
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 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.
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.
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.
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 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
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, 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)
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 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
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.
Urinary Tract Infections
Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and…
- Trial name
- NCT05091931
- Where
- 2 sites in United States
- Volunteers
- 3,308 people
- Sponsor
- Pathnostics
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