Clinical trials: Bacterial Infections
Bacterial Conjunctivitis
Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1%…
- Trial name
- NCT06911424
- Testing
- Fusidic Acid 1%
- Where
- 38 sites in United States
- Volunteers
- 400 people
- Sponsor
- Baxis Pharmaceuticals, Inc.
Infections, Bacterial
Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax
This observational, open-label, single arm, study is designed such that it may be implemented for any individual with a lab confirmed sporadic case of systemic anthrax disease treated with raxibacumab outside of the current…
- Trial name
- NCT07478471
- Testing
- Collection of samples
- Volunteers
- 10 people
- Sponsor
- Emergent BioSolutions
Bacterial Infections
Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.
- Trial name
- NCT05217537
- Testing
- Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Paratek Pharmaceuticals Inc
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections.
- Conditions
- Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP), Blood Stream Infection, Meningitis, Bacterial
- Trial name
- RIV- CARE (NCT07431307)
- Testing
- BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT)
- Volunteers
- 120 people
- Sponsor
- BioVersys AG
Infections, Bacterial
Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario
This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario.
- Trial name
- NCT02177721
- Testing
- Sample Collection
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Anthrax
Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and…
- Trial name
- NCT03569514
- Testing
- AIGIV
- Volunteers
- 10 people
- Sponsor
- Emergent BioSolutions
Inhalational Anthrax
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event.
- Trial name
- NCT03569553
- Testing
- AIGIV
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Infections, Bacterial
Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
This clinical trial is designed to evaluate if adding the Karius Spectrum™ plasma test to usual care diagnostic tests, compared to usual care testing alone, among immunocompromised participants presenting with suspected infection…
- Conditions
- Infection, Infections, Bacterial, Infections, Fungal, Infection Viral
- Trial name
- OPTIMUM (NCT07110636)
- Testing
- Metagenomic plasma-based test for agnostic pathogen detection
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Karius, Inc.
Tetanus, Diphtheria
Confirmatory Study of BK1310 in Healthy Infants
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with…
- Conditions
- Tetanus, Diphtheria, Pertussis, Poliomyelitis
- Trial name
- NCT03891758
- Testing
- DPT-IPV-Hib, Hib vaccine, DPT-IPV
- Where
- Japan
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Bacterial Vaginosis
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.
- Trial name
- NCT07302035
- Testing
- GenSci142
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Gram-positive Bacterial Infections
Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections
The purpose of this Phase 1 trial is to evaluate the pharmacokinetics (PK), safety and tolerability of oritavancin in participants <18 years old with a confirmed or suspected bacterial infection.
- Trial name
- NCT02134301
- Testing
- Oritavancin
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- Melinta Therapeutics, LLC
Bacterial Infections
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult…
- Trial name
- NCT06079775
- Testing
- Xeruborbactam Oral Prodrug, Ceftibuten
- Where
- Australia
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Bacterial Infections
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants
- Trial name
- NCT06547554
- Testing
- Xeruborbactam, Cefiderocol, Xeruborbactam/Cefiderocol
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Acute Bacterial Skin and Skin Structure Infection
Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections
This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric…
- Trial name
- NCT05599295
- Testing
- Orbactiv, Kimyrsa
- Where
- 23 sites in United States, Bulgaria and 6 more
- Volunteers
- 118 people
- Sponsor
- Melinta Therapeutics, LLC
MAC Lung Disease, Treatment Refractory MAC Lung Disease
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
- Conditions
- MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous
- Trial name
- ICoN-1 (NCT06418711)
- Testing
- Clofazimine Inhalation Suspension
- Where
- 99 sites in United States, Australia and 3 more
- Volunteers
- 132 people
- Sponsor
- Mannkind Corporation
Bacterial Infections, Urinary Tract Infections
Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts: Part 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of…
- Conditions
- Bacterial Infections, Urinary Tract Infections, Intra-Abdominal Infections, Respiratory Tract Infections
- Trial name
- NCT07207291
- Testing
- JKN2501
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd
UTI - Urinary Tract Infection, UTI - Lower Urinary Tract Infection
Clinical Impact Analysis of PA-100 AST in a Spanish GP Setting
Assessment of workflow implications of the PA-100 AST System. Using well-defined data collection protocols, the study comprises the following: Collection of clean-catch midstream urine samples Measurement of specimens on the…
- Conditions
- UTI - Urinary Tract Infection, UTI - Lower Urinary Tract Infection, AMR, Cystitis Acute
- Trial name
- NCT07189429
- Testing
- PA-100 AST
- Where
- Spain
- Volunteers
- 199 people
- Sponsor
- Sysmex Europe GmbH