Clinical trials: Gram-Negative Bacteria
Lyme Disease
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
- Trial name
- NCT03581279
- Testing
- T2Lyme Panel testing
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- T2 Biosystems
Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria
To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency
The study is an open, parallel, single-dose phase I clinical study to evaluate the pharmacokinetics and safety of TQD3606 for injection in subjects with renal insufficiency.
- Trial name
- NCT06672276
- Testing
- TQD3606
- Where
- 2 sites in China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Acinetobacter Baumannii Infection
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
This research project is being conducted to look at the safety, tolerability, and pharmacokinetics (PK; how the human body processes a substance) of ETX2514 when given to healthy volunteers intravenously as a single dose, and…
- Trial name
- NCT02971423
- Testing
- ETX2514, Sulbactam, Imipenem/Cilastatin
- Where
- Australia
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Pneumonia
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well…
- Trial name
- NCT01021436
- Testing
- Amikacin inhalation solution (BAY41-6551)
- Where
- 6 sites in United States, France
- Volunteers
- 30 people
- Sponsor
- Bayer
Atopic Dermatitis
Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study
The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis.
- Trial name
- NCT04936113
- Testing
- FB-401
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Forte Biosciences, Inc.
Bacteremia Sepsis
Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia
The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K.
- Trial name
- PHENOTECH-1 (NCT05613322)
- Testing
- Resistell Phenotech
- Where
- 3 sites in Austria, Spain and 1 more
- Volunteers
- 246 people
- Sponsor
- Resistell AG
Urinary Tract Infection Complicated, Acute Pyelonephritis
CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria
The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis…
- Trial name
- PLEA (NCT03477422)
- Testing
- CSE-1034 (Ceftriaxone + Sulbactam + EDTA), Meropenem
- Where
- 17 sites in India
- Volunteers
- 230 people
- Sponsor
- Venus Remedies Limited
Acinetobacter Baumannii Infection
Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects
This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently…
- Trial name
- NCT03310463
- Testing
- ETX2514SUL
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Atopic Dermatitis
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis.
- Trial name
- NCT04504279
- Testing
- FB-401
- Where
- 15 sites in United States
- Volunteers
- 154 people
- Sponsor
- Forte Biosciences, Inc.
Gram-negative Bacterial Infection
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.
- Trial name
- NCT01015014
- Testing
- AN3365
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infections, Respiratory Tract
A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom
The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric…
- Trial name
- NCT01292213
- Testing
- Cough swab, Oropharyngeal swab, Nasopharyngeal swabs
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- GlaxoSmithKline
Pneumonia
A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)
This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than…
- Trial name
- NCT01004445
- Testing
- Amikacin (BAY41-6551)
- Where
- 20 sites in United States, France and 1 more
- Volunteers
- 69 people
- Sponsor
- Bayer
Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram…
- Conditions
- Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia
- Trial name
- REVISIT (NCT03329092)
- Testing
- ATM-AVI, MTZ, MER
- Where
- 157 sites in United States, Argentina and 19 more
- Volunteers
- 422 people
- Sponsor
- Pfizer
Serious Bacterial Infection
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI)…
- Trial name
- NCT03580044
- Testing
- ATM-AVI, BAT
- Where
- 42 sites in United States, Argentina and 10 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Gram-Positive Bacterial Infections, Escherichia Coli Infections
Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units
To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in…
- Conditions
- Gram-Positive Bacterial Infections, Escherichia Coli Infections, Klebsiella Infections
- Trial name
- NCT00167999
- Testing
- piperacillin-tazobactam
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Bacteremia Caused by Gram-Negative Bacteria, Bacterial Pneumonia
A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection
This is a retrospective, observational, post-marketing study to evaluate the clinical response, microbiological response, mortality, and safety of intravenous polymyxin B and colistin methanesulfonate in patients with…
- Trial name
- NCT06966284
- Where
- Taiwan
- Volunteers
- 480 people
- Sponsor
- TTY Biopharm
Bacteremia Sepsis
Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis
Blood culture samples from bacteremia patients positive for Gram-negative bacteria will be tested for antibacterial susceptibility using Resistell Phenotech device.
- Trial name
- NANO-RAST (NCT05002413)
- Testing
- Resistell AST
- Where
- Switzerland
- Volunteers
- 300 people
- Sponsor
- Resistell AG
Dysentery, Bacillary
A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study
GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei. A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with…
- Trial name
- NCT03089879
- Testing
- GVGH Shigella sonnei 1790GAHB vaccine
- Where
- France
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
- Trial name
- CAP (NCT00621504)
- Testing
- Ceftaroline fosamil for Injection, IV Ceftriaxone, Clarithromycin
- Where
- 168 sites in United States, Argentina and 21 more
- Volunteers
- 606 people
- Sponsor
- Forest Laboratories