Clinical trials: Resistance Bacterial
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
Tuberculosis
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
Staphylococcal Skin Infection
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
- Trial name
- ATLAS1 (NCT00091819)
- Testing
- Telavancin, Vancomycin
- Where
- United States
- Volunteers
- 862 people
- Sponsor
- Cumberland Pharmaceuticals
Infections
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant…
- Trial name
- NCT01645735
- Testing
- Ceftaroline fosamil, Ceftriaxone plus vancomycin
- Where
- 31 sites in United States, Georgia and 6 more
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
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
E Coli Infections, Allogenic Transplant Patients
Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant
This is a Phase 1b/2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC…
- Trial name
- NCT06938867
- Testing
- SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
- Where
- 10 sites in United States
- Volunteers
- 66 people
- Sponsor
- SNIPR Biome Aps.
Methicillin Resistant Staphylococcus Aureus (MRSA)
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects.
- Trial name
- ZEPHYR (NCT00084266)
- Testing
- linezolid (Zyvox), vancomycin
- Where
- 177 sites in United States, Argentina and 20 more
- Volunteers
- 1,225 people
- Sponsor
- Pfizer
Tuberculosis, Multidrug-Resistant
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
A phase 2, multicenter, uncontrolled, open-label trial in participants with Multi-drug Resistant Tuberculosis (MDR-TB). Only participants who completed Trial 242-07-204 (NCT00685360) were eligible.
- Trial name
- NCT02573350
- Testing
- Delamanid, OBR
- Where
- 8 sites in China, Estonia and 4 more
- Volunteers
- 213 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081
This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with…
- Trial name
- WX-081 (NCT04608955)
- Testing
- WX-081, Bedaquiline, Standard treatment
- Where
- China
- Volunteers
- 99 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Tuberculosis, MDR
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance.
- Trial name
- FS-1 (NCT02607449)
- Testing
- FS-1
- Where
- 6 sites in Kazakhstan, Kyrgyzstan
- Volunteers
- 344 people
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
Resistance Bacterial
T2Resistance - Detection of Resistance Related Genes
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms: 1.
- Trial name
- NCT05231187
- Testing
- T2Resistance Panel
- Where
- 10 sites in United States
- Volunteers
- 1,566 people
- Sponsor
- T2 Biosystems
Bacterial Infections
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355).
- Trial name
- NCT02214433
- Testing
- Debio 1450 IV Solution, Debio 1450 Tablet, Debio 1450 Capsule
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Infections, Bacterial
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830
A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled, dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3342830 after administration of…
- Trial name
- NCT02751424
- Testing
- GSK3342830
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Small Intestinal Bacterial Overgrowth
Feasibility of a New Diagnostic Device to Assess Small Intestinal Dysbiosis in Routine Clinical Setting.
The purpose of this study is to determine if the gas-sensing capsule can be used to identify increased numbers and a change of the composition of microbiota or microorganisms in the gut to assess small intestinal dysbiosis
- Trial name
- NCT04910815
- Testing
- Atmo Gas Capsule, Glucose Breath Test, Fructoolifosaccharides (FOS) Breath Test
- Where
- 2 sites in Australia, India
- Volunteers
- 110 people
- Sponsor
- Atmo Biosciences Pty Ltd
Bacteremia
Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform, two…
- Trial name
- NCT01184339
- Testing
- MicroPhage S. aureus/MSSA/MRSA Blood Culture Test
- Volunteers
- 1,165 people
- Sponsor
- MicroPhage, Inc.
Respiratory Tract Infections, Corona Virus Infection
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment.
- Trial name
- NCT03331445
- Testing
- Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- Chris Miller
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multi-drug Resistant Tuberculosis
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
- Trial name
- NCT03470233
- Where
- 2 sites in South Korea
- Volunteers
- 149 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Urinary Tract Infection, Acute Pyelonephritis
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types…
- Conditions
- Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia
- Trial name
- NCT04882085
- Testing
- Zavicefta, Ceftazidime-Avibactam, Best Available Treatment
- Where
- 37 sites in China
- Volunteers
- 60 people
- Sponsor
- Pfizer
Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
Effect of a Probiotic Formula on Reducing SIBO in IBS Patients
This randomized study evaluates the effectiveness of the a probiotic formula, compared with the antibiotic rifaximin, in the treatment of Small Intestinal Bacterial Overgrowth (SIBO) in Irritable Bowel Syndrome (IBS) patients.
- Trial name
- NCT04316806
- Testing
- Probiotic, Rifaximin
- Where
- Spain
- Volunteers
- 8 people
- Sponsor
- AB Biotics, SA