Clinical trials: Bacterial Diseases
Meningococcal Disease, Infections, Meningococcal
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis…
- Trial name
- NCT01682876
- Testing
- MenACWY-CRM
- Where
- 19 sites in United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumonia, Bacterial
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures
- Trial name
- NCT05776004
- Testing
- CAL02
- Where
- 90 sites in United States, Argentina and 17 more
- Volunteers
- 276 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Pneumococcal Disease
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13.
- Trial name
- NCT05408429
- Testing
- 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine
- Where
- 43 sites in Hungary, Poland and 1 more
- Volunteers
- 356 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Bacterial Vaginosis
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
- Trial name
- PreFem (NCT03187457)
- Testing
- Metronidazole, Control: no treatment
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Danisco
Pneumococcal Infectious Disease
A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population
An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years…
- Trial name
- NCT07071701
- Testing
- 23-valent pneumococcal polysaccharide vaccine, Influenza vaccine
- Where
- China
- Volunteers
- 19,267 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Fungal Infection
A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001
This is a Phase 1, open-label study to evaluate the drug-drug interaction potential of a strong CYP3A4 inhibitor (itraconazole) and a pan-CYP inducer (rifampin) on APX001 in two parallel groups of healthy subjects.
- Trial name
- NCT04166669
- Testing
- APX001, Itraconazole, Rifampin
- Where
- 2 sites in Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Impetigo
Safety and Efficacy of Mupirocin Gel in Children With Impetigo
The purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical administration of Mupirocin Ointment 20 mg/g TID (three…
- Trial name
- NCT04287777
- Testing
- Mupirocin gel, Mupirocin ointment
- Where
- 20 sites in Spain
- Volunteers
- 467 people
- Sponsor
- Reig Jofre Group
Whooping Cough
The Safety of Boostrix Following Routine Immunization of Pregnant Women
The purpose of this study was to assess the safety of Boostrix administered on or after the first day of the 27th week of pregnancy by conducting a post-marketing study that provided safety information to the public and…
- Trial name
- NCT03463577
- Testing
- Safety assessment following routine immunization with Boostrix
- Where
- United States
- Volunteers
- 65,783 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Complicated Skin and Skin Structure Infections
Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
The purpose of this study is to determine the clinical efficacy, safety, and tolerability of a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated skin and skin structure infections (cSSSIs).
- Trial name
- NCT01128530
- Testing
- JNJ-32729463, linezolid
- Where
- 27 sites in United States
- Volunteers
- 161 people
- Sponsor
- Furiex Pharmaceuticals, Inc
Candidemia
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - <18 years) with invasive candidiasis, including candidemia (ICC).
- Trial name
- NCT00761267
- Testing
- Anidulafungin, Fluconazole
- Where
- 45 sites in United States, Brazil and 8 more
- Volunteers
- 70 people
- Sponsor
- Pfizer
Mycoses
Bioequivalence Study for Terbinafine 250 mg
The objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent. Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product Lamisil® 250 mg (Novartis).
- Trial name
- NCT01772212
- Testing
- Terbinafine 250 mg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant…
- Trial name
- WISH (NCT05824871)
- Testing
- Sudapyridine, Bedaquiline
- Where
- 2 sites in China
- Volunteers
- 450 people
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Fungal Infection
Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects
First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects.
- Trial name
- NCT02956499
- Testing
- APX001 single dose 1, APX001 single dose 2, APX001 single dose 3
- Where
- 2 sites in Netherlands
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Anthrax
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Primary: To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 To evaluate…
- Trial name
- NCT01202695
- Testing
- AVP-21D9
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Tuberculosis, Pulmonary
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but…
- Trial name
- CONSTAN-ARG (NCT05455112)
- Testing
- RUTI® Vaccine
- Where
- 2 sites in Argentina
- Volunteers
- 41 people
- Sponsor
- Archivel Farma S.L.
Meningococcal Infection, Healthy Volunteers
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China.
- Trial name
- NCT07710872
- Testing
- MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA), Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China)
- Where
- 8 sites in China
- Volunteers
- 4,568 people, healthy volunteers welcome
- Sponsor
- Sanofi
Meningococcal Disease
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a…
- Trial name
- NCT01823536
- Testing
- Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
- Where
- 16 sites in United States, Ukraine
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Mycoses
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)
The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of…
- Trial name
- NCT00726609
- Testing
- Posaconazole
- Volunteers
- 214 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
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