Clinical trials: Infection, Bacterial
Pneumonia, Bacterial, Pneumococcal Infections
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
This is a Phase 2 clinical study evaluating AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of three different…
- Conditions
- Pneumonia, Bacterial, Pneumococcal Infections, Pneumonia, Pneumococcal
- Trial name
- NCT05412030
- Testing
- AFX3772, Prevnar 13, Prevnar 20
- Where
- 52 sites in United States, Puerto Rico
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Bacterial Skin and Skin Structure Infections
Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in…
- Trial name
- NCT03137173
- Testing
- ceftobiprole medocaril, vancomycin+aztreonam
- Where
- 34 sites in United States, Bulgaria and 2 more
- Volunteers
- 679 people
- Sponsor
- Basilea Pharmaceutica
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, 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
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
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
Acute Bacterial Skin and Skin Structure Infections
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and…
- Trial name
- NCT03176134
- Testing
- Tedizolid phosphate, Comparator
- Where
- 58 sites in United States, Brazil and 12 more
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Tract Infections, Acute Pyelonephritis
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.
- Trial name
- CERTAIN-1 (NCT03840148)
- Testing
- Cefepime/VNRX-5133 (taniborbactam), Meropenem
- Where
- 78 sites in United States, Argentina and 13 more
- Volunteers
- 661 people
- Sponsor
- Venatorx Pharmaceuticals, Inc.
Bacterial Infections
MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections
- Trial name
- ABSSSI (NCT02269319)
- Testing
- MRX-I, Linezolid
- Volunteers
- 120 people
- Sponsor
- MicuRx
Bacterial Vaginosis, Vaginal Infection
Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
The goal of this clinical trial is to show the efficacy and safety of dequalinium chloride in the treatment of bacterial vaginosis compared to metronidazole.
- Conditions
- Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases
- Trial name
- NCT05788991
- Testing
- Dequalinium Chloride, Metronidazole Oral
- Where
- 14 sites in Czechia, Poland and 1 more
- Volunteers
- 151 people
- Sponsor
- Medinova AG
Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by…
- Conditions
- Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
- Trial name
- NCT02814916
- Testing
- Dalbavancin, Vancomycin, Oxacillin
- Where
- 84 sites in United States, Argentina and 18 more
- Volunteers
- 199 people
- Sponsor
- AbbVie
Gram-Positive Bacterial Infections
Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)
This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes
- Trial name
- NCT02013141
- Testing
- Telavancin
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- Cumberland Pharmaceuticals
Bacterial Infection Due to Streptococcus, Group B, Streptococcus Agalactiae
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the…
- Trial name
- NCT02690181
- Testing
- GBS Trivalent Vaccine
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gram-negative Bacterial Infection
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age.
- Trial name
- NOOR (NCT04126031)
- Testing
- Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3, Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
- Where
- 18 sites in United States, Estonia and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Infections, Bacterial
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population.
- Trial name
- NCT02339155
- Testing
- AVA, Raxibacumab, Diphenhydramine
- Where
- 3 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Suspected or Documented Gram-negative Bacterial Infection
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed…
- Trial name
- NCT03230916
- Testing
- IMI/REL FDC
- Where
- 33 sites in United States, Bulgaria and 6 more
- Volunteers
- 47 people
- Sponsor
- Merck Sharp & Dohme LLC
Serious Bacterial Infection
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI)…
- Trial name
- NCT03580044
- Testing
- ATM-AVI, BAT
- Where
- 42 sites in United States, Argentina and 10 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events.
- Conditions
- Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
- Trial name
- NCT01072539
- Testing
- tigecycline
- Where
- 36 sites in South Korea
- Volunteers
- 3,172 people
- Sponsor
- Pfizer
Pneumonia, Bacterial, Healthy Volunteers
A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in adults 18 to 64 years of age in Stage 1.
- Conditions
- Pneumonia, Bacterial, Healthy Volunteers, Pneumococcal Disease
- Trial name
- NCT03803202
- Testing
- ASP3772, PCV13, PPSV23
- Where
- 26 sites in United States
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Bacterial Skin and Skin Structure Infection
A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI)…
- Trial name
- NCT02452918
- Testing
- Oritavancin, Warfarin
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- The Medicines Company