Clinical trials: Drug Resistance, Multiple, Bacterial
Tuberculosis Infection
Intensifying Multi-Drug Resistant Tuberculosis Contact Tracing by Social Network Analysis
Tuberculosis burden in Vietnam increasing with contribution from low detection rates and increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant Tuberculosis) among both notified TB cases and their…
- Trial name
- SNAP (NCT02175849)
- Where
- Vietnam
- Volunteers
- 596 people
- Sponsor
- Oxford University Clinical Research Unit, Vietnam
Tuberculosis, Multidrug-Resistant
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
- Trial name
- NCT06674291
- Testing
- No intervention (observational study)
- Volunteers
- 222 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Tuberculosis
Effect of Xpert MTB/RIF on Patient Outcomes
A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB diagnosis and TB treatment; 3) presumptive…
- Trial name
- NCT02729532
- Testing
- Xpert
- Where
- Zambia
- Volunteers
- 776 people
- Sponsor
- University of North Carolina, Chapel Hill
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
PredictEndTB Signature for Individualizing Treatment in Multidrug-Resistant Tuberculosis
PredictEndTB signature is a non-inferiority, prospective, parallel-group open-label randomized controlled trial evaluating the efficacy of individualised antituberculous treatment durations that utilize the transcriptomic…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Bacterial Infections, Mycobacterial Infection
- Trial name
- NCT04783727
- Testing
- Individualised treatment duration based on RNA transcriptomic model
- Where
- 5 sites in Germany, Moldova and 2 more
- Volunteers
- 4 people
- Sponsor
- Research Center Borstel
Bacteremia, Healthcare-associated Pneumonia
Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria
Background and rationale: Antimicrobial resistance is a global public health threat. An increasing number of Gram-negative bacteria isolates worldwide are resistant to virtually all antibiotics including carbapenems.
- Conditions
- Bacteremia, Healthcare-associated Pneumonia, Ventilator-associated Pneumonia
- Trial name
- XDR-GNB (NCT02134106)
- Testing
- Polymyxin B, Polymyxin B + Doripenem
- Where
- 2 sites in Singapore
- Sponsor
- Tan Tock Seng Hospital
Tuberculosis
Early Access of TMC207 in Patients With Extensively Drug Resistant or Pre-XDR Pulmonary Tuberculosis
The purpose of this is a study to provide early access of TMC207 to patients with pulmonary infection due to strains of Mycobacterium tuberculosis (M.
- Trial name
- NCT01464762
- Testing
- TMC207
- Where
- 5 sites in Lithuania, Russia
- Sponsor
- Janssen Infectious Diseases BVBA
HIV Infections, Tuberculosis
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.
To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB).
- Trial name
- NCT00000796
- Testing
- Cycloserine, Ethionamide, Capreomycin sulfate
- Where
- 21 sites in United States
- Volunteers
- 525 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, MDR
FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance.
- Trial name
- FS-1 (NCT02607449)
- Testing
- FS-1
- Where
- 6 sites in Kazakhstan, Kyrgyzstan
- Volunteers
- 344 people
- Sponsor
- Scientific Center for Anti-infectious Drugs, Kazakhstan
MDR-TB, Tuberculosis Multi Drug Resistant Active
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
The FAST-MDR trial is an externally-controlled, multicentre trial with one prospective arm, evaluating the non-inferiority of the effectiveness of BPaLM in the interventional arm versus the effectiveness of the long, conventional…
- Conditions
- MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis
- Trial name
- FAST-MDR (NCT07486024)
- Testing
- Bedaquiline Oral Tablet
- Where
- 5 sites in France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Pneumonia, Pneumonia - Bacterial
Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities (RESPIRE)
This is a single-center, non-profit observational study with two sequential phases: an initial retrospective phase followed by a prospective phase. Patients were enrolled during two consecutive, non-overlapping periods.
- Conditions
- Pneumonia, Pneumonia - Bacterial, Multi Drug Resistant, Multi Drug Resistant Organisms
- Trial name
- RESPIRE (NCT07425561)
- Testing
- RESPIRE score
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Drug Resistance, Multiple, Bacterial, Cholangiopancreatography, Endoscopic Retrograde
Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use.
- Trial name
- PREVENT (NCT05303662)
- Testing
- Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs, MDRO-testing duodenal aspirate, Microbiome through rectal swab
- Where
- 4 sites in United States, India and 2 more
- Volunteers
- 1,244 people
- Sponsor
- Marco J. Bruno
Pleural Empyema, Tuberculosis (TB)
The Role of Decortication in Complex Empyema Cases: Multidrug Resistance and Tuberculosis at the Forefront
Empyema is a problem that thoracic surgeons deal in everyday practice. The main goal of treatment is evacuating the pus and fibrin deposits in the thoracic cavity for complete lung expansion.
- Conditions
- Pleural Empyema, Tuberculosis (TB), Bacterial Sepsis
- Trial name
- NCT07167823
- Testing
- Decortication
- Where
- Pakistan
- Volunteers
- 350 people
- Sponsor
- University of Health Sciences Lahore
Tuberculosis, MDR
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among…
- Trial name
- PHOENIx MDR-TB (NCT03568383)
- Testing
- Delamanid (DLM), Isoniazid (INH), Pyridoxine (vitamin B6)
- Where
- 31 sites in Botswana, Brazil and 11 more
- Volunteers
- 5,832 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Tuberculosis, Pre-XDR-TB
Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care
BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid…
- Conditions
- Tuberculosis, Pre-XDR-TB, Extensively Drug-Resistant Tuberculosis, Multi Drug Resistant Tuberculosis
- Trial name
- NCT04062201
- Testing
- Bedaquiline Oral Tablet, Linezolid Oral Tablet, Delamanid in Oral Dosage Form
- Where
- 2 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Wits Health Consortium (Pty) Ltd
Pulmonary Tuberculosis
The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)
The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary…
- Trial name
- NCT06476210
- Testing
- BDL regimen
- Where
- 7 sites in China
- Volunteers
- 45 people
- Sponsor
- Beijing Chest Hospital
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
Aztreonam-Avibactam in Immunocompromised Hosts
The goal of this observational study is to learn about the effectiveness and safety of aztreonam-avibactam (ATM-AVI), an antibiotic used to treat infections caused by highly resistant bacteria, in adults with weakened immune…
- Conditions
- Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection, Immunocompromised Host, Drug Resistance, Multiple, Bacterial
- Trial name
- IMMUNO-AVI (NCT07890480)
- Testing
- Aztreonam-Avibactam, Ceftazidime-Avibactam Plus Aztreonam
- Where
- Argentina
- Volunteers
- 814 people
- Sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
ACS - Acute Coronary Syndrome, Ticagrelor
Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor
The FLORA-ACS study aims to evaluate the relationship between dysbiosis and high platelet reactivity during treatment with ticagrelor in patients with a history of acute coronary syndromes and investigate the use of rifaximin to…
- Conditions
- ACS - Acute Coronary Syndrome, Ticagrelor, Microbiota, Platelet Aggregation
- Trial name
- FLORA-ACS (NCT07203846)
- Testing
- Rifaximin
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Collegium Medicum w Bydgoszczy
Mechanically Ventilated Patients
The Effect of Uroshield on Sputum-specimen Bacterial Growth
The investigators retrospectively register the conduct of this study after its completion.
- Trial name
- NCT06729476
- Testing
- Uroshield vibrator device
- Volunteers
- 48 people
- Sponsor
- Shaare Zedek Medical Center
Serious Bacterial Infection
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI)…
- Trial name
- NCT03580044
- Testing
- ATM-AVI, BAT
- Where
- 42 sites in United States, Argentina and 10 more
- Volunteers
- 15 people
- Sponsor
- Pfizer