Clinical trials: Multi-antibiotic Resistance
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.
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
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
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
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.
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
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
Lung Diseases, Pulmonary Disease
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects…
- Conditions
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung
- Trial name
- NCT03309358
- Testing
- Inhaled SNSP113
- Where
- 2 sites in United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Synspira, Inc.
Infectious Diseases, Antimicrobial Drug Resistance
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.
- Trial name
- NCT07029932
- Testing
- BWC0977
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bugworks Research Inc.
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
- Trial name
- CAP (NCT00509106)
- Testing
- Ceftaroline fosamil for Injection, Ceftriaxone
- Where
- 134 sites in United States, Argentina and 13 more
- Volunteers
- 622 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