Clinical trials: Drug Resistance, Bacterial
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
- Trial name
- CAP (NCT00621504)
- Testing
- Ceftaroline fosamil for Injection, IV Ceftriaxone, Clarithromycin
- Where
- 168 sites in United States, Argentina and 21 more
- Volunteers
- 606 people
- Sponsor
- Forest Laboratories
Helicobacter Pylori Infection, Helicobacter Pylori Gastritis
Helicobacter Pylori Local Prevalence and Antibiotic Resistance
The clinical management of H. pylori infection depends essentially on two factors, prevalence and local resistance. In Germany, only limited data from rather small cohorts currently exist regarding both factors.
- Conditions
- Helicobacter Pylori Infection, Helicobacter Pylori Gastritis, Drug Resistant Bacterial Infection, Antibiotic Resistant Infection
- Trial name
- HelicoPTER (NCT05561504)
- Where
- Germany
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Technical University of Munich
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, 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
Gram-Negative Bacterial Infections
Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem
The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria
- Trial name
- NCT01732250
- Testing
- Colistin, Meropenem
- Where
- 7 sites in Greece, Israel and 1 more
- Volunteers
- 406 people
- Sponsor
- Mical Paul
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
Tuberculosis, Drug-resistant Tuberculosis
Rewards for Tuberculosis Contact Screening
This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and…
- Trial name
- RECON (NCT02234908)
- Testing
- Contacts, Index
- Where
- 2 sites in South Africa
- Volunteers
- 301 people
- Sponsor
- Boston University
Hematologic Neoplasms, Gram-Negative Bacterial Infections
Ceftazidime-Avibactam PK/PD and Resistance in Hematology Patients
This is a prospective, single-arm, observational, exploratory clinical study to evaluate whether the standard fixed dose of ceftazidime-avibactam (CAZ-AVI) achieves sufficient drug exposure (pharmacokinetic/pharmacodynamic, or…
- Conditions
- Hematologic Neoplasms, Gram-Negative Bacterial Infections, Pseudomonas Aeruginosa Infection, Klebsiella Pneumoniae Infections
- Trial name
- CZA-TDM (NCT07703644)
- Testing
- Ceftazidime-avibactam, Therapeutic Drug Monitoring (TDM) and Microbiological Surveillance
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sizhou Feng
Latent Tuberculosis
Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
- Trial name
- NCT02454738
- Testing
- Ultralow dose chest CT scan
- Where
- South Korea
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Pulmonary Tuberculosis
Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for…
- Trial name
- NCT05359315
- Testing
- Interferon-Gamma
- Where
- Russia
- Volunteers
- 84 people
- Sponsor
- SPP Pharmaclon 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
Pulmonary Tuberculoses, Aspergillosis
Pulmonary Aspergillosis in Tuberculosis Patients
Pulmonary tuberculosis (PTB) is the most common cause of lung destruction, contributing to coinfections development, and Aspergillosis spp. is one of the most important.
- Conditions
- Pulmonary Tuberculoses, Aspergillosis, Old Tuberculosis, Active Tuberculosis
- Trial name
- NCT05045391
- Testing
- Aspergillus IgG detection
- Where
- Uzbekistan
- Volunteers
- 200 people
- Sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
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
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)
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or…
- Trial name
- QUANTUM-TB (NCT07209761)
- Testing
- Bedaquiline, Quabodepistat, Pretomanid
- Where
- 42 sites in China, Georgia and 8 more
- Volunteers
- 532 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Drug Resistance, Multiple, Bacterial
Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU
Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will…
- Trial name
- BLSE-REA (NCT05833282)
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Tourcoing Hospital
Tuberculosis, HIV
Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV
Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter in Ukraine. After many years of laboratory and clinical testing the formulation was approved in 1997 by the Ministry of Health of Ukraine…
- Trial name
- NCT01061593
- Testing
- Immunoxel
- Where
- 2 sites in Mongolia, Ukraine
- Volunteers
- 269 people
- Sponsor
- Lisichansk Regional Tuberculosis Dispensary
Infection, Bacterial, Antibiotic Side Effect
Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics.
- Conditions
- Infection, Bacterial, Antibiotic Side Effect, Antibiotic Resistant Infection, Sepsis
- Trial name
- MD-PK (NCT05950984)
- Testing
- Drug Infusion Pump Monitoring
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- St George's, University of London
Multi-drug Resistant Tuberculosis
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
- Trial name
- NCT01600963
- Testing
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Where
- 44 sites in Brazil, Cambodia and 15 more
- Sponsor
- Janssen Infectious Diseases BVBA
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