Clinical trials: Resistant Infection
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
HIV-1 Infection
UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients
This is a Phase 2, multi-center study, designed to evaluate the efficacy, safety, and tolerability of UB-421 in conjunction with a failing existing ART regimen for 1 week and optimized background therapy (OBT) for 24 weeks…
- Trial name
- NCT03164447
- Testing
- UB-421, Optimized background therapy (OBT)
- Volunteers
- 10 people
- Sponsor
- United BioPharma
Chronic Hepatitis B
A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection
The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in…
- Trial name
- NCT00605384
- Testing
- Entecavir + Tenofovir, Adefovir + continuing Lamivudine
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 4 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.
- Trial name
- NCT00126880
- Testing
- AVX754, 3TC
- Where
- Australia
- Volunteers
- 52 people
- Sponsor
- Avexa
Tuberculosis, Multidrug-Resistant
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB)…
- Trial name
- NCT02365623
- Testing
- TMC207 (bedaquiline), Background Regimen (BR)
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Janssen Pharmaceutical K.K.
Dengue, Chikungunya
Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa
The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the…
- Conditions
- Dengue, Chikungunya, Malaria
- Trial name
- NCT06257810
- Testing
- VIDAS® Dengue Antigen NS1, VIDAS® Anti-Dengue IgM, VIDAS® Anti-Dengue IgG, VIDAS® Anti-Chikungunya IgM and VIDAS® Anti-Chikungunya IgG, Standard of care practices
- Where
- 3 sites in Burkina Faso, Côte d’Ivoire
- Volunteers
- 804 people
- Sponsor
- BioMérieux
Skin Infections, Bacterial
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA.
- Trial name
- NCT00852540
- Testing
- Retpamulin Ointment, 1%, Linezolid
- Where
- 53 sites in United States
- Volunteers
- 410 people
- Sponsor
- Stiefel, a GSK Company
Healthy Volunteers, Anti-Bacterial Agents
A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers
To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin® SAL200 following single and multiple ascending doses in healthy male volunteers after continuous intravenous infusion over 60 minutes.
- Conditions
- Healthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus Infection
- Trial name
- NCT03446053
- Testing
- N-Rephasin® SAL200
- Where
- South Korea
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
Infective Endocarditis
Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE
- Trial name
- NCT00638157
- Testing
- daptomycin, daptomycin and gentamicin
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Skin and Subcutaneous Tissue Bacterial Infections, Skin Structures and Soft Tissue Infections
Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.
- Trial name
- NCT01984684
- Testing
- delafloxacin, vancomycin, aztreonam
- Where
- 94 sites in United States, Argentina and 14 more
- Volunteers
- 850 people
- Sponsor
- Melinta Therapeutics, Inc.
Bacteremia
Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
- Trial name
- NCT01640886
- Where
- 3 sites in United States
- Volunteers
- 764 people
- Sponsor
- MicroPhage, Inc.
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.
Gram-Positive Bacterial Infections
Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.
- Trial name
- NCT00055198
- Testing
- daptomycin
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hepatitis C Virus Infection
A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies
This is a follow-up study with no treatment and only samples being collected.
- Trial name
- NCT00872196
- Testing
- ABT-072
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA), (Susceptible or Methicillin Resistant)
Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus
The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
- Trial name
- NCT01211470
- Testing
- Daptomycin, PMX-30063-investigational drug
- Where
- 8 sites in Canada, Russia and 1 more
- Volunteers
- 215 people
- Sponsor
- PolyMedix, Inc.
Catecholamine-resistant Hypotension (CRH), Distributive Shock
A Study of LJPC-501 in Pediatric Patients With Hypotension
The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients…
- Conditions
- Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis
- Trial name
- NCT03431077
- Testing
- Angiotensin II
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- La Jolla Pharmaceutical Company
Skin and Soft Tissue Infections, Methicillin-resistant Staphylococcus Aureus
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site.
- Trial name
- NCT00989872
- Testing
- EDP-322
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Endocarditis, Bacterial, Infective Endocarditis
Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of…
- Trial name
- HDSAB (NCT00695903)
- Testing
- daptomycin, vancomycin
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diagnosis, Gonorrhea
Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections
This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples. The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation…
- Conditions
- Diagnosis, Gonorrhea, Resistance Bacterial
- Trial name
- STING (NCT06352554)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- SpeeDx Pty Ltd
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