Clinical trials: Bacterial Resistance
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.
Staphylococcus Aureus
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
This study involves the use of investigational vaccines. A vaccine is a medicine that causes the body to make antibodies. Antibodies help destroy foreign substances that enter the body.
- Trial name
- NCT01011335
- Testing
- Monovalent rAT, Monovalent rLukS-PV, Bivalent rLukS-PV / rAT
- Where
- 2 sites in United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
Resistance Bacterial, Morality
Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)
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
- Resistance Bacterial, Morality, Child Health, Implementation
- Trial name
- AVENIR (NCT05288023)
- Testing
- Azithromycin for Oral Suspension
- Where
- United States
- Volunteers
- 169,707 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Multi-drug Resistant Tuberculosis
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
- Trial name
- NCT04309656
- Testing
- Pretomanid
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Chronic Abdominal Pain, Small Intestinal Bacterial Overgrowth
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment.
- Trial name
- CAP&SIBO (NCT00619970)
- Testing
- Lactulose Breath Test, xifaxan
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Los Angeles
Tuberculosis, Pulmonary, Rifampicin Resistant Tuberculosis
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing.
- Trial name
- XPEL-TB (NCT03044158)
- Testing
- GeneXpert I, Process re-design, Performance Feedback
- Where
- 20 sites in Uganda
- Volunteers
- 10,644 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Pulmonary Disease, Tuberculosis, Pulmonary
A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects
- Conditions
- Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT05526911
- Testing
- TBAJ-876, Midazolam, Digoxin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Bacterial Infection, Multiple-drug Resistance
Intravenous Fosfomycin Pharmacokinetics Study
This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window).
- Conditions
- Bacterial Infection, Multiple-drug Resistance, Pathogen Resistance
- Trial name
- NCT03910673
- Testing
- Fosfomycin disodium
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Staphylococcal Infection, Abscess
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA).
- Conditions
- Staphylococcal Infection, Abscess, Staphylococcal Skin Infection, Folliculitis
- Trial name
- NCT00352612
- Testing
- clindamycin, cephalexin
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Aaron Chen
Healthy Volunteers
Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota
The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.
- Trial name
- NCT01473368
- Testing
- Saccharomyces boulardii, Amoxicillin Clavulanate
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Small Bowel Bacterial Overgrowth, Gastrointestinal Diseases
Transit Time and Bacterial Overgrowth Using SmartPill Capsule
The primary purpose of this exploratory study is to measure orocecal transit time using the SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath test.
- Conditions
- Small Bowel Bacterial Overgrowth, Gastrointestinal Diseases, Stomach Diseases, Digestive System Diseases
- Trial name
- NCT00577772
- Testing
- Xifaxan, SmartPill, Lactulose hydrogen breath test (H_2BT)
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Human Gut Microbiota
Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers.
- Trial name
- NCT01414010
- Testing
- Trametes versicolor extract, Saccharomyces boulardii, Amoxicillin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
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, Bacterial
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830
A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled, dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3342830 after administration of…
- Trial name
- NCT02751424
- Testing
- GSK3342830
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Child Growth, Diversity of Microbiome
MORDOR II Burkina Faso: Longitudinal Trial
Globally, childhood mortality has shown a promising downward trend in recent years, however, many sub-Saharan countries still have relatively high child mortality rates.
- Conditions
- Child Growth, Diversity of Microbiome, Child Mortality, Resistance Bacterial
- Trial name
- GAMIN (NCT03676751)
- Testing
- Azithromycin
- Where
- Burkina Faso
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
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
Staphylococcus Aureus, MRSA Skin Infections
Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees
This cluster-randomized prospective study will evaluate the effect of hygiene-based intervention strategies on the incidence of overall SSTI and MRSA-associated SSTI among military trainees.
- Conditions
- Staphylococcus Aureus, MRSA Skin Infections, Staphylococcal Skin Infections
- Trial name
- NCT01105767
- Testing
- Chlorhexidine gluconate, Supplemental training, education and hygiene
- Where
- United States
- Volunteers
- 30,209 people, healthy volunteers welcome
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine