Clinical trials: Gram Negative Infections
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Pneumonia, Hematologic Malignancy
Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
The goal of this clinical trial is to learn whether the antibiotic ceftolozane-tazobactam works to treat serious Pseudomonas aeruginosa infections in people with blood cancers or who received a stem cell transplant.
- Conditions
- Pneumonia, Hematologic Malignancy, Pseudomonas Aeruginosa Infection, Bacteremia
- Trial name
- NCT04673175
- Testing
- Ceftolozane / Tazobactam Injection
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Weill Medical College of Cornell University
Multi-resistant Gram-negative Bacteria Cause Infection
To Evaluate the Pharmacokinetics and Safety of TQD3524 for Injection in Renal Impairment Subjects
This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQD3524 injection in patients with renal impairment after a single dose, and to evaluate the…
- Trial name
- NCT06522945
- Testing
- TQD3524
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIs
Extracorporeal Therapy and Therapeutic Drug Monitoring
The aim of this study is to comparatively evaluate serum concentrations of continuously applied antibiotics in ICU patients, with and without ECMO/RRT support.
- Trial name
- NCT07287813
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Meningococcal Infections
Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
Phase 2/3 study to evaluate immunogenicity and safety in healthy adult participants following a single dose administration of Meningococcal (groups A, C, W-135, and Y) conjugate vaccine
- Trial name
- NCT07204457
- Testing
- EG-MCV4, Menveo
- Where
- South Korea
- Volunteers
- 1,123 people, healthy volunteers welcome
- Sponsor
- EyeGene Inc.
Gram Negative Infections, Sepsis and Septic Shock
A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections
The goal of this clinical trial is to : 1. Test whether the combination of CAZ±AVI and FOS leads to superior clinical outcomes in patients with severe suspected Gram-negative bacterial infection, as demonstrated by a shorter time…
- Trial name
- CAVIFOS (NCT07063095)
- Testing
- Ceftazidime± avibactam with fosfomycin
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Angela HUTTNER
Gram-negative Bacterial Infections
Pharmacokinetics and Safety of HRS-8427 in Healthy Volunteers and in Patients With Impaired Renal Function
This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal…
- Trial name
- NCT07070375
- Testing
- HRS-8427
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Gram Negative Pneumonia, Gram-Negative Bacterial Infections
Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV
This study is designed to evaluate the clinical and antibacterial efficacy, safety and pharmacokinetics of the drug Fluorothiazinone compared to placebo to prevent nosocomial gram-negative bacterial infections with participation…
- Conditions
- Gram Negative Pneumonia, Gram-Negative Bacterial Infections, Bacteremia Caused by Gram-Negative Bacteria
- Trial name
- NCT06135350
- Testing
- Fluorothiazinone, tablets 300 mg at a dose of 2400 mg/day
- Where
- 2 sites in Russia
- Volunteers
- 234 people
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
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
Gram Negative Infection, Antimicrobial Resistance (AMR)
PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections
A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination…
- Trial name
- PACCOF (NCT06651047)
- Where
- 11 sites in Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Bologna
Bacterial Infections, Bone Diseases, Infectious
Fosfomycin I.v. for Treatment of Severely Infected Patients
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin…
- Conditions
- Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections
- Trial name
- FORTRESS (NCT02979951)
- Where
- 50 sites in Austria, Germany and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Infectopharm Arzneimittel GmbH
Carbapenem-Resistant Enterobacteriaceae Infection, KPC
Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections
This is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing…
- Conditions
- Carbapenem-Resistant Enterobacteriaceae Infection, KPC, Gram-Negative Bacterial Infections, Antibiotic Resistant Infection
- Trial name
- NCT04785924
- Testing
- Imipenem+Relebactam
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
Gram Negative Infections
Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India.
- Trial name
- NCT04628572
- Testing
- Ceftazidime-avibactam
- Where
- 8 sites in India
- Volunteers
- 189 people
- Sponsor
- Pfizer
Gram-negative Bacterial Infection
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age.
- Trial name
- NOOR (NCT04126031)
- Testing
- Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3, Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
- Where
- 18 sites in United States, Estonia and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Gram-negative Bacteria, Lipid Metabolism
Lipid Kinetics of Patients With Pneumonia
Nonfermenting Gram-Negative Bacilli (NFGNB) are aerobic, non-motile, non-lactose fermenting, oxidase-negative, catalase-positive coccobacilli that pose a serious threat to critically ill patients.
- Conditions
- Gram-negative Bacteria, Lipid Metabolism, Nosocomial Infections
- Trial name
- NCT04748432
- Where
- Turkey (Türkiye)
- Volunteers
- 131 people
- Sponsor
- Konya Numune Hospital
Carbapenem-Resistant Enterobacteriaceae Infection, Bloodstream Infection
Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections
Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the…
- Conditions
- Carbapenem-Resistant Enterobacteriaceae Infection, Bloodstream Infection, Severe Infection, Pseudomonas Aeruginosa
- Trial name
- OPTIMISE (NCT05210387)
- Testing
- Duration of therapy
- Where
- 29 sites in Brazil
- Volunteers
- 107 people
- Sponsor
- Hospital Moinhos de Vento
Suspected or Documented Gram-negative Bacterial Infection
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed…
- Trial name
- NCT03230916
- Testing
- IMI/REL FDC
- Where
- 33 sites in United States, Bulgaria and 6 more
- Volunteers
- 47 people
- Sponsor
- Merck Sharp & Dohme LLC
Gram-negative Bacterial Infections
Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates
This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center…
- Trial name
- NCT00394784
- Where
- United States
- Sponsor
- University of Pittsburgh
Adenovirus, Anesthesia
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved.
- Conditions
- Adenovirus, Anesthesia, Anxiety, Anxiolysis
- Trial name
- PTN_POPS (NCT01431326)
- Testing
- The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 3,520 people
- Sponsor
- Daniel Benjamin
Gram-Negative Bacterial Infections
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Minocin® (Minocycline) for Infections Caused by Gram-negative Bacteria in a Real World Setting
This study is a retrospective, observational study to evaluate minocycline use in participants under real world conditions.
- Trial name
- NCT03160040
- Testing
- Minocycline IV
- Where
- 6 sites in United States
- Volunteers
- 71 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)