Clinical trials: Antibiotic Resistance
Febrile Neutropenia
Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics
Administration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels of amphotericin B that are as mycologically…
- Trial name
- NCT00421187
- Testing
- Liposomal amphotericin B (AmBisome®)
- Where
- Greece
- Volunteers
- 20 people
- Sponsor
- Gilead Sciences
Antimicrobial Agent, Cephalosporins
Effect of Ceftobiprole on Human Intestinal Microflora
The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.
- Conditions
- Antimicrobial Agent, Cephalosporins, Drug Resistance
- Trial name
- NCT00965042
- Testing
- Ceftobiprole
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized…
- Trial name
- VITORA (NCT03944369)
- Testing
- KB109, No intervention
- Where
- 8 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kaleido Biosciences
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
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
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
Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder)
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
This study evaluates safety and tolerability of endolysin-derived LSVT-1701 (tonabacase) as an add-on to standard of care (SOC) antibiotic therapy for the treatment of patients with complicated Staphylococcus aureus bacteremia…
- Conditions
- Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder), Right Sided Infective Endocarditis (Disorder), Endocarditis Infective
- Trial name
- ERASE (NCT05329168)
- Testing
- Tonabacase (LSVT-1701)
- Where
- United States
- Sponsor
- Lysovant
Prosthetic Joint Infection
Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT04763759
- Testing
- TRL1068, a human monoclonal antibody
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Trellis Bioscience LLC
Chronic Rhinosinusitis With Nasal Polyps
Study to Evaluate Safety and Activity of TRL1068 in Chronic Rhinosinusitis
TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT05355207
- Testing
- TRL1068
- Volunteers
- 12 people
- Sponsor
- Trellis Bioscience LLC
UTI - Lower Urinary Tract Infection, Antibiotic Resistant Infection
Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
This is a prospective, Phase 4, open label, multi-center study of the clinical and microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infections in adult women.
- Trial name
- NCT03366207
- Testing
- Ciprofloxacin
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Iterum Therapeutics, International Limited
Helicobacter Pylori Gastritis
Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.
The goal of this trial is to compare the non-inferiority efficacy and safety of two different treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily (PLA, test) vs.
- Trial name
- NCT02726269
- Testing
- CLA (Clarithro+Lanso+Amoxi), PLA (Panto+Levoflox+Azithro)
- Volunteers
- 230 people
- Sponsor
- Asofarma de México S.A de C.V.
Intestinal Bacteria Flora Disturbance
Multi-Antibiotic Resistance Carriage in Gut Flora
Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.
- Trial name
- MARC (NCT01591538)
- Where
- France
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Da Volterra
Staphylococcus Aureus Bacteremia, Anti-Bacterial Agents
Phase IIa Clinical Study of N-Rephasin® SAL200
This study is performed to evaluate safety and to explore the efficacy of a single intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard treatment, for persistent Staphylococcus aureus…
- Trial name
- NCT03089697
- Testing
- N-Rephasin® SAL200
- Where
- 2 sites in South Korea
- Volunteers
- 25 people
- Sponsor
- Intron Biotechnology, Inc.
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Infection, Soft Tissue, Infection, Wound
Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion
This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic…
- Conditions
- Infection, Soft Tissue, Infection, Wound, Cellulitis, Diabetic Foot Ulcer
- Trial name
- DAD (NCT01238276)
- Testing
- Cefazolin, Silberg Tissue Preparation System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sonescence, Inc.
Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee
Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT06621251
- Testing
- TRL1068 (calpurbatug), a human monoclonal antibody, DAIR
- Where
- 11 sites in United States
- Volunteers
- 60 people
- Sponsor
- Trellis Bioscience LLC
Bacterial Infections
Children's Antibiotic Resistant Infections in Low Income Countries
The main challenge of the ChARLI program is to assess the clinical burden of severe neonatal and childhood bacterial infections in low-income countries,in particular those caused by antibiotic resistant bacteria.
- Trial name
- ChARLI (NCT02074865)
- Testing
- biological samples
- Where
- Madagascar
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Drug Resistance, Bacterial, Antimicrobial Drug Resistance
Fecal Microbiota Transplantation (FMT) to Decolonize Antibiotic - Resistant Bacteria (ARB) - New Protocol
The aim of the study is to assess the safety and efficacy of new protocol fecal microbiota transplantation (FMT) in the eradication of antibiotic resistant bacteria, including those featuring of resistance to new generation…
- Trial name
- STOP-ARB2 (NCT06156956)
- Testing
- Fecal Microbiota Transplantation
- Where
- 5 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Human Biome S.A.
Community-acquired Pneumonia
Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia
The primary purpose of this study is to effect of Ingaron®, a lyophilisate for the preparation of a solution for intramuscular and subcutaneous administration of 100,000 IU (LLC NPP Farmaklon, Russia) on the effectiveness of…
- Trial name
- NCT05395702
- Testing
- Interferon-Gamma
- Where
- Russia
- Volunteers
- 114 people
- Sponsor
- SPP Pharmaclon Ltd.