Clinical trials: Complicated Urinary Tract Infections(cUTI)
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.
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, Pyelonephritis
Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)
The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of MK-7655 (relebactam) to imipenem/cilastatin in adults 18 years or older with complicated urinary tract infection…
- Trial name
- NCT01505634
- Testing
- Relebactam 250 mg, Relebactam 125 mg, imipenem/cilastatin 500 mg
- Volunteers
- 302 people
- Sponsor
- Merck Sharp & Dohme LLC
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 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.
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 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 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
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; 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.
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 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
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
- Trial name
- NCT01595438
- Testing
- Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
- Where
- 80 sites in United States, Argentina and 20 more
- Volunteers
- 598 people
- Sponsor
- Pfizer
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
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 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
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 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.
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, 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)