Clinical trials: Gram-negative Bacterial Infections
Gram-negative Bacterial Infection
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.
- Trial name
- CHERISH (NCT06462235)
- Testing
- Part A: ATM-AVI Single Dose, Cohorts 1-4, Part B: Multiple-dose ATM-AVI, Cohorts 1-4
- Where
- 32 sites in United States, Argentina and 7 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Hematologic Neoplasms, Gram-Negative Bacterial Infections
Ceftazidime-Avibactam PK/PD and Resistance in Hematology Patients
This is a prospective, single-arm, observational, exploratory clinical study to evaluate whether the standard fixed dose of ceftazidime-avibactam (CAZ-AVI) achieves sufficient drug exposure (pharmacokinetic/pharmacodynamic, or…
- Conditions
- Hematologic Neoplasms, Gram-Negative Bacterial Infections, Pseudomonas Aeruginosa Infection, Klebsiella Pneumoniae Infections
- Trial name
- CZA-TDM (NCT07703644)
- Testing
- Ceftazidime-avibactam, Therapeutic Drug Monitoring (TDM) and Microbiological Surveillance
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sizhou Feng
Severe Pneumonia Caused by Multidrug-resistant Gram-negative Bacterial Infection
A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bacterial Infections
This study aims to evaluate the clinical efficacy of a traditional Chinese medicine formula granule (Feireqing Granules) in the treatment of severe pneumonia caused by multidrug-resistant Gram-negative bacterial infections…
- Trial name
- NCT07206745
- Testing
- Fei Re Qing Granules
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Henan University of Traditional Chinese Medicine
Lyme Disease
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of TP05 administered orally to healthy adult participants.
- Trial name
- NCT07562087
- Testing
- TP-05 (lotilaner) Low Dose, TP-05 (lotilaner) High Dose
- Where
- 19 sites in United States
- Volunteers
- 722 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Gram-negative Bacterial Infections
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
- Trial name
- NCT05639647
- Testing
- ATM-AVI, BAT
- Where
- 23 sites in United States, China and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Multidrug-Resistant Gram-Negative Bacterial Infections, Antimicrobial Resistance
The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections
This study evaluates whether adding melatonin to standard colistin therapy improves outcomes in patients with multidrug-resistant (MDR) Gram-negative bacterial infections.
- Trial name
- NCT07503600
- Testing
- Melatonin
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Gram-Negative Bacterial Infections
Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit
Antimicrobial resistance is a global health emergency estimated to be responsible for 700,000 deaths per year worldwide, and it is well known that previous antibiotic exposure is the single most contributing factor.
- Trial name
- RESTART (NCT05171257)
- Testing
- IV antibiotic treatment from prior, differing IV antibiotic treatment
- Where
- United States
- Volunteers
- 197 people
- Sponsor
- Methodist Health System
Ceftazidime-avibactam, Aztreonam
Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB
Metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), due to their capacity to hydrolyze almost all β-lactam antibiotics, have become a critical global threat in antimicrobial resistance.
- Conditions
- Ceftazidime-avibactam, Aztreonam, Gram-negative Bacterial Infection, Metallo-β-lactamase-producing
- Trial name
- NCT07478484
- Testing
- ceftazidime-avibactam combined with aztreonam
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Jing Zhou
Drug Clearance After Severe Burn Injury
Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
Cefiderocol is a powerful, broad spectrum antibiotic approved to treat hospital-acquired or ventilator associated pneumonia and urinary tract infections.
- Trial name
- NCT07465432
- Testing
- Cefiderocol
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Tennessee
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
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
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
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 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
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 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