Clinical trials: Multiple-drug Resistance
Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized…
- Trial name
- VITORA (NCT03944369)
- Testing
- KB109, No intervention
- Where
- 8 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kaleido Biosciences
Metastatic Prostate Cancer
Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
The main purpose of this study is to assess the safety and tolerability of AZD0516 as monotherapy and/or in combination with other anti-cancer agents for treatment of metastatic prostate cancer.
- Trial name
- SEACLIFF (NCT07181161)
- Testing
- AZD0516, AZD9574
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 283 people
- Sponsor
- AstraZeneca
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
Healthy
DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin
This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg tablets qd × 7 days) on the PK of single-dose…
- Trial name
- NCT02300363
- Testing
- Treatment A (rosuvastatin), Treatment B (LX4211), Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Cancer, Pancreatic Cancer
9-ING-41 in Patients With Advanced Cancers
GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in…
- Conditions
- Cancer, Pancreatic Cancer, Sarcoma, Renal Cancer
- Trial name
- NCT03678883
- Testing
- 9-ING-41, Gemcitabine - 21 day cycle, Doxorubicin.
- Where
- 66 sites in United States, Belgium and 5 more
- Volunteers
- 350 people
- Sponsor
- Actuate Therapeutics Inc.
Resistant Hypertension
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.
- Trial name
- NCT00272961
- Testing
- TBC3711
- Where
- 12 sites in United States
- Volunteers
- 60 people
- Sponsor
- Pfizer
Tuberculosis
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
The objective of this study is to demonstrate that the antibacterial activity of TMC207 is better than placebo when added to a standardized Background Regimen (BR) for treatment of multi-drug resistant TB.
- Trial name
- NCT00449644
- Testing
- TMC207, Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)
- Where
- 16 sites in Brazil, India and 6 more
- Volunteers
- 208 people
- Sponsor
- Janssen Infectious Diseases BVBA
Non-small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC)
A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.
The purpose of this study was to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer Microsatellite Stable (MSS)
- Trial name
- NCT03549000
- Testing
- NZV930, PDR001, NIR178
- Where
- 10 sites in United States, Australia and 5 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Fallopian Tube Cancer, Ovarian Cancer
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Trial name
- NCT00091377
- Testing
- cisplatin, paclitaxel, phenoxodiol
- Where
- 2 sites in United States, Australia
- Volunteers
- 65 people
- Sponsor
- MEI Pharma, Inc.
Melanoma
LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the…
- Trial name
- LOGIC-2 (NCT02159066)
- Testing
- LGX818, MEK162, LEE011
- Where
- 32 sites in United States, Australia and 7 more
- Volunteers
- 158 people
- Sponsor
- Pfizer
Infantile Spasms (IS)
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)
The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms
- Trial name
- NCT02829827
- Testing
- Radiprodil
- Where
- France
- Volunteers
- 3 people
- Sponsor
- UCB Biopharma S.P.R.L.
Tuberous Sclerosis Complex, Epilepsy
Safety and Efficacy of AV078 in Participants With Tuberous Sclerosis Complex (TSC) Refractory Epilepsy (RESTOR-1)
This Phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and efficacy of oral AV078 in participants with refractory epilepsy due to tuberous sclerosis complex (TSC).
- Trial name
- RESTOR-1 (NCT07680322)
- Testing
- AV078
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- Aeovian Pharmaceuticals, Inc.
HIV-1-infection
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency…
- Trial name
- CAPELLA (NCT04150068)
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Failing ARV Regimen
- Where
- 75 sites in United States, Canada and 9 more
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
HIV
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects.
- Trial name
- NCT02707861
- Testing
- ibalizumab, Optimized Background Regimen
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 79 people
- Sponsor
- TaiMed Biologics Inc.
Metastatic Castration-resistant Prostate Cancer
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
Phase 1: The objective of the Phase 1 part of the clinical trial is to verify safety and tolerability (dose-limiting toxicity [DLT], maximum tolerated dose [MTD]) of a single 3.7 Giga-Becquerel (GBq) dose with the potential for…
- Trial name
- LUCIDA (NCT05458544)
- Testing
- [177Lu]Ludotadipep 3.7 GBq
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- FutureChem
Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)
This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days.
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug Resistant, Extensively Drug-Resistant Tuberculosis
- Trial name
- NCT00685360
- Testing
- Delamanid, Optimized Background Regimen (OBR)
- Where
- 17 sites in United States, China and 7 more
- Volunteers
- 481 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.