Clinical trials: Multidrug-Resistant Bacterial Infections
Tuberculosis, Multidrug-Resistant
Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients
Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice.
- Trial name
- PERFECT (NCT03409315)
- Testing
- Centralized Therapeutic Drug Monitoring
- Where
- 13 sites in Australia, Belarus and 11 more
- Volunteers
- 360 people
- Sponsor
- University Medical Center Groningen
Cirrhosis, Bacterial Infections
International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
What is this study about? This study tracks antibiotic resistance in patients with cirrhosis who develop bacterial infections. Cirrhosis is a condition where the liver is severely scarred, and people with cirrhosis are at high…
- Conditions
- Cirrhosis, Bacterial Infections, Multidrug Resistance
- Trial name
- NCT06634940
- Where
- Argentina
- Volunteers
- 1,000 people
- Sponsor
- Hospital Italiano de Buenos Aires
Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis
Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With Resistant Tuberculosis: A Clinical Trial
Tuberculosis increases energy demands and protein breakdown, leading to muscle wasting. Malnutrition and minimal weight gain less than 5% in first two months predict treatment failure.
- Conditions
- Tuberculosis Multi Drug Resistant Active, Rifampin-Resistant Pulmonary Tuberculosis, Pre-xdr tb
- Trial name
- NCT07058233
- Testing
- Oral nutritional supplementation
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- RSUP Persahabatan
Tuberculosis, Multidrug-Resistant
DIAgnostics for Multidrug Resistant Tuberculosis in Africa
Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin…
- Trial name
- DIAMA (NCT03303963)
- Testing
- Deeplex test, MolBio TrueNat for 2nd line, GeneXpert 2nd line, Fluorescein DiAcetate (FDA) Microscopy,GeneXpert Ct value, pre-rRNA synthesis
- Where
- 10 sites in Belgium, Benin and 8 more
- Volunteers
- 3,356 people
- Sponsor
- Dissou AFFOLABI
Gram Negative Bacterial Infections
Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected…
- Trial name
- NCT02117986
- Testing
- colistin
- Where
- 2 sites in Chile
- Volunteers
- 200 people
- Sponsor
- Hospital Barros Luco Trudeau
Mycobacterium Abscessus Infection, Bacteriophage Therapy
Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection
The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant…
- Conditions
- Mycobacterium Abscessus Infection, Bacteriophage Therapy, Pulmonary Disease
- Trial name
- NCT07429162
- Testing
- DP-QB-MYA-002
- Volunteers
- 1 people
- Sponsor
- Alberta Health services
Enterobacteriaceae Infections
Effect of Imipenem and Meropenem on the Digestive Microbiota and the Emergence and Carriage of Multidrug-resistant Bacteria
Among enterobacteria, ESBL production is the leading cause of multidrug resistance. The first cases of ESBL-producing Enterobacteriaceae (EBLSE) infections were described in the 1980s and subsequently spread worldwide.
- Trial name
- MERIMI (NCT05516433)
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Antimicrobial Drug Resistance, Antibiotic Resistant Infection
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or…
- Conditions
- Antimicrobial Drug Resistance, Antibiotic Resistant Infection, Clostridium Difficile, Carbapenem-Resistant Enterobacteriaceae Infection
- Trial name
- DYNAMITE (NCT06258551)
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Pulmonary Tuberculosis
Directly Observed Therapy Short Course-Plus Versus DOTS for Retreatment of Relapsed Pulmonary Tuberculosis in Guangzhou
This is a prospective, randomized, parallel, controlled study comparing the efficacy and outcomes in the retreatment of pulmonary Tuberculosis (TB) in Guangzhou in a group using pretreatment susceptibility tests in selection of…
- Trial name
- NCT01618422
- Testing
- Directly Observed Therapy (DOTS) plus, Directly Observed Therapy (DOTS)
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Chinese University of Hong Kong
Prostatitis, Escherichia Coli Infection
Oral Fosfomycin as Sequential Oral Treatment for Multidrug-Resistant Escherichia Coli in Acute Bacterial Prostatitis
FOS-PROST was a prospective, non-randomized, controlled phase IV clinical trial designed to evaluate the clinical and microbiological efficacy of oral fosfomycin trometamol as sequential antibiotic therapy in patients with acute…
- Trial name
- FOS-PROST (NCT07902427)
- Testing
- Fosfomycin Trometamol Salt, control group
- Where
- 7 sites in Spain
- Volunteers
- 88 people
- Sponsor
- Hospital Mutua de Terrassa
Septicemia, Bacterial Infections
Efficacy and Safety of Colistin Based Antibiotic Therapy
To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit.
- Trial name
- NCT04764058
- Testing
- Tienam 500, Infusion
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Bacterial Infections
Developing a Risk Assessment System of Multidrug-resistant Organisms Infection
1. A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019. 2.
- Trial name
- NCT04688216
- Testing
- risk factors of infection with multidrug-resistant organisms
- Where
- China
- Volunteers
- 917 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Infections, Bacterial
In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance
Observational: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals.
- Trial name
- NCT01132417
- Testing
- In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance
- Where
- Saudi Arabia
- Volunteers
- 500 people
- Sponsor
- King Faisal University
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
Lung Tuberculosis, MDR TB
Tuberculosis Research of INA-RESPOND On Drug Resistance
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray…
- Trial name
- TRIPOD (NCT02758236)
- Testing
- No Intervention
- Where
- 7 sites in Indonesia
- Volunteers
- 490 people
- Sponsor
- Ina-Respond
Extended Spectrum Beta Lactamases (ESBL) E. Coli
Developing Microbials to Fight Extended-spectrum Beta-lactamase (ESBL)-Producing Escherichia Coli
This study is to identify and isolate well-defined microbials (non-ESBL E. coli) in an observational setting exploring natural gastrointestinal decolonization of humans colonized with ESBL E. coli.
- Trial name
- NCT04764500
- Testing
- examination of stool sample, patient questionnaire, examination of blood sample
- Where
- Switzerland
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in…
- Conditions
- Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis, Pre-XDR-TB
- Trial name
- INSPIRE-TB (NCT05081401)
- Testing
- Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z, A1, A2a
- Where
- 5 sites in China
- Volunteers
- 1,050 people
- Sponsor
- Huashan Hospital
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Multidrug-Resistant
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB)…
- Trial name
- NCT02365623
- Testing
- TMC207 (bedaquiline), Background Regimen (BR)
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Janssen Pharmaceutical K.K.
HIV-1-infection, Pneumocystis Pneumonia
Impact of Cotrimoxazole Use in Immunocompetent HIV Patients on Carriage of Antimicrobial Resistant Bacteria
Cotrimoxazole preventive therapy (CPT) is recommended for prevention of morbidity and mortality due to Pneumocystis pneumonia and other infections in HIV positive patients with low immunity.
- Conditions
- HIV-1-infection, Pneumocystis Pneumonia, Opportunistic Infections, Preventive Therapy
- Trial name
- CoTrimResist (NCT03087890)
- Testing
- Cotrimoxazole
- Where
- 6 sites in Tanzania
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- University of Bergen