Clinical trials: Antibiotic Resistance
Mycobacterium Infections, Nontuberculous
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary…
- Trial name
- OPTIMA (NCT03421743)
- Testing
- Inhaled molgramostim, Antimycobacterial regimen
- Where
- 5 sites in Australia, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Savara Inc.
Bacterial Resistance
Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics
1. Background: Over 1 million intravitreal injections are performed annually in the United States. The most devastating complication related to these injections is endophthalmitis, with an incidence of 0.02 - 0.1% per injection.
- Trial name
- NCT02223338
- Testing
- Ciprofloxacin, Standard Aseptic Technique
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Loma Linda University
Healthy Volunteers, Anti-Bacterial Agents
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers
The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.
- Conditions
- Healthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus
- Trial name
- NCT01855048
- Testing
- N-Rephasin® SAL200
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Intron Biotechnology, Inc.
Infections
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant…
- Trial name
- NCT01645735
- Testing
- Ceftaroline fosamil, Ceftriaxone plus vancomycin
- Where
- 31 sites in United States, Georgia and 6 more
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
The purpose of this superiority study is to evaluate the efficacy and safety of exebacase in addition to standard of care antibiotics (SoCA) compared with SoCA alone for the treatment of patients with Staphylococcus aureus (S.
- Trial name
- DISRUPT (NCT04160468)
- Testing
- Exebacase
- Where
- 55 sites in United States
- Volunteers
- 259 people
- Sponsor
- ContraFect
Staphylococcal Skin Infections
Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin.
- Trial name
- DAPHEOR1006 (NCT01419184)
- Testing
- Daptomycin, Vancomycin
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 250 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
P Acnes Colonization
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.
- Trial name
- NCT00907101
- Testing
- Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Galderma R&D
Dysbiosis, Antimicrobial Resistant Organism
Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis or Clearance of ARO
The objective of this study is to assess the efficacy of FMTs via rectal administration for 1) symptom improvement in individuals with a formal diagnosis of dysbiosis due to active inflammatory bowel disease or irritable bowel…
- Trial name
- FMTGID (NCT03834051)
- Testing
- Fecal Microbiota Transplantation
- Where
- Canada
- Volunteers
- 33 people
- Sponsor
- Vancouver Island Health Authority
Mortality, Resistance Bacterial
Azithromycin for Child Survival in Niger: Mortality and Resistance Trial
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include…
- Conditions
- Mortality, Resistance Bacterial, Child, Only
- Trial name
- AVENIR (NCT04224987)
- Testing
- Azithromycin
- Where
- Niger
- Volunteers
- 864,493 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Helicobacter Infections
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication.
- Trial name
- NCT00669955
- Testing
- Omeprazole, amoxicillin, clarithromycin, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
- Where
- United Kingdom
- Volunteers
- 440 people
- Sponsor
- Forest Laboratories
Child Development
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome.
- Trial name
- ARMCA (NCT03187834)
- Testing
- Azithromycin, Amoxicillin, Cotrimoxazole
- Where
- 2 sites in United States, Burkina Faso
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus
Active Bathing to Eliminate Infection (ABATE Infection) Trial
The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units.
- Conditions
- Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms
- Trial name
- ABATE (NCT02063867)
- Testing
- Arm 2: Decolonization
- Where
- 52 sites in United States
- Volunteers
- 53 people
- Sponsor
- University of California, Irvine
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, Inc.
Antibiotic Resistance, Ocular Surface Microbiome
Antibiotic Resistance In Eye Surgeries
In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of…
- Conditions
- Antibiotic Resistance, Ocular Surface Microbiome, Gut Resistome
- Trial name
- ARIES (NCT04750655)
- Testing
- Moxifloxacin (Topical)
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- University of California, San Francisco
Acute Otitis Media
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at…
- Trial name
- NCT02630992
- Testing
- Amoxicillin-Clavulanate potassium
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Nader Shaikh
Infection With Multi-drug Resistant Organisms
FMT for Multidrug Resistant Organism Reversal
This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of…
- Trial name
- NCT02312986
- Testing
- Fecal microbiota transplantation (FMT)
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
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 Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- cSSSI (NCT00424190)
- Testing
- IV Vancomycin plus IV Aztreonam, Ceftaroline
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 698 people
- Sponsor
- Forest Laboratories
Antimicrobial Resistance, Attitude to Health
Testing New Ways to Name Antimicrobial Resistance
This study aims to investigate the public's views on antibiotics and the impact of different ways to name the potential consequences of antibiotics not working in the future.
- Trial name
- NCT06356285
- Testing
- Presentation of Antimicrobial Resistance
- Where
- United Kingdom
- Volunteers
- 4,296 people, healthy volunteers welcome
- Sponsor
- Imperial College London