Clinical trials: Antimicrobial Prophylaxis
Surgical Site Infection
Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative…
- Trial name
- NCT04218110
- Testing
- Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic, Prevantics 3.15 % / 70 % Swabstick
- Where
- Romania
- Volunteers
- 329 people, healthy volunteers welcome
- Sponsor
- Professional Disposables International, Inc.
Healthcare Associated Infection
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.
- Trial name
- NCT03189043
- Testing
- Antimicrobial Surface
- Volunteers
- 10,000 people
- Sponsor
- Aionx, Inc.
Diarrhea, Clostridium Infections
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
- Trial name
- NCT00328263
- Testing
- Lactobacillus acidophilus CL1285 and Lactobacillus casei
- Where
- 8 sites in Canada
- Volunteers
- 472 people
- Sponsor
- Bio-K Plus International Inc.
Antibiotic-associated Diarrhea
Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
The goal of this study was to investigate the efficacy and safety of LRG-002 investigational medicinal product, capsules (Lek d.d., Slovenia) in comparison with placebo, as an adjunct treatment for prophylaxis of…
- Trial name
- NCT04321460
- Testing
- LRG-002
- Where
- 3 sites in Russia
- Volunteers
- 520 people
- Sponsor
- Sandoz
Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to…
- Trial name
- NCT00958308
- Testing
- BIO-K+ CL-1285®
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Bio-K Plus International Inc.
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.
Acute Otitis Media
Bio-Kult Infantis® in AAD Prevention in Infants
Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the intestinal mucosa associated to the administration of antibiotics.
- Trial name
- NCT03516409
- Testing
- Biokult
- Where
- Italy
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Probiotics International Ltd.
Proven or Suspected Gram-negative Bacterial Infection, Peri-operative Prophylaxis
Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)
The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants.
- Trial name
- NCT02266706
- Testing
- Ceftolozane/Tazobactam 1000/500 mg, Ceftolozane/Tazobactam 30/15 mg/kg, Ceftolozane/Tazobactam 20/10 mg/kg
- Volunteers
- 43 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Infectious Disease, Bacterial Infections
Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients
The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis, (ii) is it effective in reducing the nasal…
- Trial name
- NCT01746654
- Testing
- P128-0.1 mg, P128-0.3 mg, P128-1.0 mg
- Where
- Singapore
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GangaGen, Inc.
Catheter-Associated Infections, Catheter-Related Infections
Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution
The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock…
- Trial name
- NCT02577718
- Testing
- Nitroglycerin-citrate-ethanol (NiCE)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Novel Anti-Infective Technologies, LLC
Dental Prophylaxis and Implant Surgery
Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the…
- Trial name
- NCT02319668
- Testing
- 0.2% w/v Chlorhexidine digluconate, Sodium fluoride toothpaste (Aquafresh Mild & Minty)
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Difficile Infection
Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
Patients with confirmed C. difficile infection (CDI) who meet eligibility requirements will be invited to participate. All study patients must receive treatment for CDI with metronidazole or vancomycin.
- Trial name
- NCT01077245
- Testing
- MIYA-BM Fine Granules (CBM588)
- Sponsor
- Osel, Inc.
Diarrhea
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients.
- Trial name
- NCT01382199
- Testing
- Lactoferrin
- Volunteers
- 340 people
- Sponsor
- Ventria Bioscience
Surgical Site Infection, Thrombosis
Tumescent Anesthesia Antibiotic Delivery (TAAD)
This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery: Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food \& Drug Administration (FDA) has approved our…
- Conditions
- Surgical Site Infection, Thrombosis, Sepsis
- Trial name
- TAAD (NCT03226626)
- Testing
- Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD, SubQKath
- Volunteers
- 330 people
- Sponsor
- HK Surgical, Inc.
HIV Infections, Gonorrhea
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydial Infections, Genital Herpes
- Trial name
- NCT00262106
- Testing
- PRO 2000/5
- Where
- 6 sites in South Africa, Tanzania and 2 more
- Volunteers
- 9,404 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Prosthetic-joint Infection
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement…
- Trial name
- RETAIN (NCT07214311)
- Testing
- PLG0206
- Where
- 21 sites in United States, United Kingdom
- Volunteers
- 240 people
- Sponsor
- Peptilogics
Infections
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery.
- Trial name
- 3gCefPK (NCT05205486)
- Testing
- Cefazolin 3gm for Injection USP and Dextrose Injection USP
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- B. Braun Medical Inc.
Urinary Tract Infections
A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment…
- Trial name
- NCT07371429
- Testing
- Gepotidacin, SOC
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
SARS-CoV-2
A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for COVID-19 [Covigenix VAX-001] in Adults
This study is a Phase I/II clinical study in healthy adults designed to assess the safety, tolerability, and immunogenicity of receiving 2 IM injections of Covigenix VAX-001/-1b, 28 days apart.
- Trial name
- NCT04591184
- Testing
- Covigenix VAX-001
- Where
- 4 sites in Burkina Faso, Canada and 2 more
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Entos Pharmaceuticals Inc.
Anthrax
Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or doxycycline when administered orally, prior to, and following, the intramuscular (IM) administration of a two-dose schedule of AV7909…
- Trial name
- NCT04067011
- Testing
- Ciprofloxacin 500Mg Tablet, Doxycycline 100Mg Tablet, AV7909
- Where
- 4 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions