A Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection (PJI) of the Hip or Knee

Study Type: A multi-site, parallel group, randomized trial.
Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints.
Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.

Start Date01 Nov 2021

Sponsor / Collaborator

Osteal Therapeutics, Inc.

NCT03721328 / CompletedPhase 2

A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection (PJI) With Alternating Irrigation of Vancomycin Hydrochloride (HCl) and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty

Study Type
Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.
Primary Study Objective
The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.
Primary Outcome Measure
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Follow-up
Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.

Start Date26 Oct 2018

Sponsor / Collaborator

Osteal Therapeutics, Inc.

NCT03066453 / TerminatedPhase 3IIT

Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.

The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.

Start Date13 Jun 2017

Sponsor / Collaborator

Centre Hospitalier Universitaire de Lille

100 Clinical Results associated with Tobramycin Sulfate

100 Translational Medicine associated with Tobramycin Sulfate

100 Patents (Medical) associated with Tobramycin Sulfate

170

Literatures (Medical) associated with Tobramycin Sulfate

01 Oct 2021·Journal of advanced pharmaceutical technology & research

Investigating nanostructured liquid crystalline particles as prospective ocular delivery vehicle for tobramycin sulfate

Article

Author: Kaul, Shreya ; Nagaich, Upendra ; Verma, Navneet

Tobramycin remains the anchor drug for bacterial keratitis treatment and management; however, unlike other aminoglycosides, it does not pass through the gastrointestinal tract. The aim of the current investigation was to formulate tobramycin-loaded nanostructured liquid crystalline particles as an ophthalmic drug delivery system to ameliorate its preocular residence duration and ophthalmic bioavailability. Tobramycin cubosomes were fabricated by liquid–lipid monoolein, water, and poloxamer 407 as a stabilizer. Corneal penetration studies exhibited that the apparent permeation coefficient of tobramycin cubosomes was nearly 3.6-fold greater than marketed tobramycin eye drops. Ocular in vivo analysis performed in rabbits' eyes manifested that the intensity of bacterial keratitis was reduced on day 3, and on day 5, the manifestations were considerably mitigated with tobramycin cubosomes as compared to marked eye drops. Pharmacokinetic study of rabbit aqueous humor demonstrated that the area under curve and the peak concentration of optimized cubosomes were 3.1-fold and 3.3-fold, respectively, which was significantly higher than marketed eye drops. Moreover, histopathological studies illustrated the existence of normal ocular structures, thus indicating that there was no damage to the corneal epithelium or stromal layer. Consequently, the results acquired demonstrated that tobramycin-loaded cubosomal formulation could be a propitious lipid-based nanodelivery system that would enhance retention time and corneal permeability contrast to commercial eye drops.

26 Nov 2020·Recent patents on anti-infective drug discovery

Investigating The Retention Potential of Chitosan Nanoparticulate Gel: Design, Development, In Vitro & Ex Vivo Characterization

Article

Author: Kaul, Shreya ; Pandey, Jaya ; Nagaich, Upendra ; Jain, Neha

Introduction::

The main purpose of the research was to develop, optimize and characterize tobramycin sulphate loaded chitosan nanoparticles based gel in order to ameliorate its therapeutic efficacy, precorneal residence time, stability, targeting and to provide controlled release of the drug.

Methods::

Box-Behnken design was used to optimize formulation by 3-factors (chitosan, STPP and tween 80) and 3-levels. Developed formulation was subjected for characterizations such as shape and surface morphology, zeta potential, particle size, in vitro drug release studies, entrapment efficiency of drug, visual inspection, pH, viscosity, spreadability, drug content, ex vivo transcorneal permeation studies, ocular tolerance test, antimicrobial studies, isotonicity evaluation and histopathology studies.

Results::

Based on the evaluation parameters, the optimized formulation showed a particle size of 43.85 ± 0.86 nm and entrapment efficiency 91.56% ± 1.04, PDI 0.254. Cumulative in vitro drug release was up to 92.21% ± 1.71 for 12 hours and drug content was found between 95.36% ± 1.25 to 98.8% ± 1.34. TEM analysis unfolded spherical shape of nanoparticles. TS loaded nanoparticulate gel exhibited significantly higher transcorneal permeation as well as bioadhesion when compared with marketed formulation. Ocular tolerance was evaluated by HET-CAM test and formulation was non-irritant and well-tolerated. Histopathology studies revealed that there was no evidence of damage to the normal structure of the goat cornea. As per ICH guidelines, stability studies were conducted and were subjected for 6 months.

Conclusion::

Results revealed that the developed formulation could be an ideal substitute for conventional eye drops for the treatment of bacterial keratitis.

01 Mar 2020·Environmental science and pollution research internationalQ3 · ENVIRONMENTAL SCIENCE & ECOLOGY

Ecotoxicological study of six drugs in Aliivibrio fischeri, Daphnia magna and Raphidocelis subcapitata

Q3 · ENVIRONMENTAL SCIENCE & ECOLOGY

Article

Author: Cannavò, Mariachiara ; Aso, Elena ; Ros, Natalia ; Lapeña, David ; Errazquin, Diego ; Giner, Beatriz ; Lomba, Laura

The presence of drugs in the environment is an emerging issue in the scientific community. It has been shown that these substances are active chemicals that consequently affect aquatic organisms and, finally, humans as end users. To evaluate the toxicity of these compounds and how they affect the environment, it is important to perform systematic ecotoxicological and physicochemical studies. The best way to address this problem is to conduct studies on different aquatic trophic levels. In this work, an ecotoxicological study of six drugs (anhydrous caffeine, diphenhydramine hydrochloride, gentamicin sulphate, lidocaine hydrochloride, tobramycin sulphate and enalapril maleate) that used three aquatic biological models (Raphidocelis subcapitata, Aliivibrio fischeri and Daphnia magna) was performed. Additionally, the concentration of chlorophyll in the algae R. subcapitata was measured. Furthermore, EC50 values were analysed using the Passino and Smith classification (PSC) method, which categorized the compounds as toxic or relatively toxic. All of the studied drugs showed clear concentration-dependent toxic effects. The toxicity of the chemicals depended on the biological model studied, with Raphidocelis subcapitata being the most sensitive species and Aliivibrio fischeri being the least sensitive. The results indicate that the most toxic compound, for all the studied biological models, was diphenhydramine hydrochloride. Graphical abstract.

News (Medical) associated with Tobramycin Sulfate

14 Nov 2024

·www.globenewswire.com

Osteal Therapeutics Announces Positive 12-Month Results from the APEX Clinical Trial Program at the 2024 American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting

Outcomes at 12 months demonstrate a statistically significant net treatment effect of 19% compared to the standard of care two-stage exchange arthroplasty and highlight a 71% reduction in PJI burdenDALLAS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, announced positive 12-month results from the two APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials of VT-X7 KIT (vancomycin hydrochloride for irrigation; tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) in patients with periprosthetic joint infections (“PJI”) of the hip or knee. The two prospective, randomized, comparative studies evaluated the efficacy of a rapid (7-day) exchange arthroplasty with intra-articular antibiotic irrigation versus the current standard of care, two-stage exchange arthroplasty. Results were featured at the 2024 American Association of Hip and Knee Surgeons (AAHKS) annual meeting and were presented by Dr. Nicolas S. Piuzzi, MD, of the Cleveland Clinic Foundation in Cleveland, Ohio. The APEX clinical program enrolled 152 patients across 23 centers in the U.S., with 76 patients treated in each study arm. Results demonstrated a statistically significant net treatment effect at 12-months of 19% (MSIS Tier 1, VT-X7: 71% vs. Control: 52%). Additionally, the median time to revision arthroplasty was significantly shorter at 7 days in VT-X7 patients compared to 98 days in patients with standard two-stage exchange. Of those patients completing revision arthroplasty (VT-X7: 100% vs. Control: 82%), patients treated with VT-X7 had a shorter overall procedure time by 62 minutes compared to patients treated with two-stage exchange. When considering the overall burden of PJI to the patients during the study follow-up period (i.e. time spent without a permanent implant and/or time spent as a failure), VT-X7 reduced PJI burden by 71% compared to standard two-stage exchange. Overall, the 12-month results demonstrated both a statistically significant and clinically meaningful treatment effect with VT-X7 compared to standard two-stage exchange. “A periprosthetic joint infection presents a significant challenge, with treatment often requiring multiple surgeries and prolonged rounds of antibiotics, which can profoundly disrupt a patient’s life. The APEX clinical program results are impressive, demonstrating a clinical advantage of rapid exchange arthroplasty with target site irrigation and providing surgeons with a promising, transformative approach to treating PJI, one that addresses the need to expedite infection eradication and allow patients to reclaim their lives.” says Dr. Piuzzi, Principal Investigator for the APEX-2 clinical study. About Periprosthetic Joint Infection (PJI) Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. About VT-X7 KIT VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, two well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need in PJI. About Osteal Therapeutics, Inc. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7 KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com Corporate Contact: Todd SaundersVice President of MarketingOsteal Therapeutics, Inc.Phone: 469-809-2630Email: info@ostealtx.com

Clinical ResultFast TrackOrphan DrugBreakthrough TherapyQualified Infectious Disease Product

05 Aug 2024

·www.globenewswire.com

Osteal Therapeutics Presents Positive Six-Month Results from the APEX Clinical Trial Program at the 34th Annual Musculoskeletal Infection Society Meeting

The six-month efficacy endpoint of overall success showed a statistically significant improvement over standard of care, two-stage exchange arthroplastyDALLAS, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, presented positive results from the two APEX (Abbreviated Protocol for Two Stage Exchange) randomized controlled clinical trials of the VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) in patients with periprosthetic joint infections (“PJI”) of the hip or knee. Results were presented by Dr. Nicolas S. Piuzzi, MD of the Cleveland Clinic Foundation in Cleveland, Ohio at the 34th Annual Musculoskeletal Infection Society meeting. The two APEX clinical trials, consisting of more than 150 patients, demonstrated VT-X7 met the six-month efficacy endpoint, achieving a statistically significant improvement in overall success with a net treatment effect of 41% in patients treated with VT-X7 versus standard of care two-stage exchange arthroplasty. All VT-X7 patients received a permanent implant at Stage 2 versus 75% of control arm patients. The median time to Stage 2 surgery was also significantly shorter, at 7 days, compared to 102 days in the control arm. “The six-month results of the APEX clinical trials are highly encouraging. PJI is a debilitating condition associated with morbidity and mortality, and VT-X7 is a groundbreaking approach to its treatment. This therapy has the potential to transform current, highly variable treatment outcomes by offering a very effective solution in a considerably shorter timeframe. This is very promising from both the patients’ and surgeons’ perspectives, with the potential to significantly enhance both quality of life and treatment success.” says Dr. Piuzzi, Principal Investigator for the APEX-2 clinical study. About Periprosthetic Joint Infection (PJI) Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. About VT-X7 KIT VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, 2 well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need in PJI. About Osteal Therapeutics, Inc. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7 KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com Corporate Contact: Todd SaundersVice President of MarketingOsteal Therapeutics, Inc.Phone: 469-809-2630Email: info@ostealtx.com

Clinical ResultFast TrackOrphan DrugQualified Infectious Disease ProductBreakthrough Therapy

06 Jun 2024

·www.globenewswire.com

Osteal Therapeutics Closes $50M Series D Financing to Support Approval and Commercial Launch of Lead Candidate

Financing led by Zimmer Biomet with participation from existing investors Johnson & Johnson Innovation – JJDC, Inc., Gideon Strategic Partners, and HM Capital. Proceeds will support NDA submission and commercial launch of lead candidate, VT-X7, a 7-day treatment for periprosthetic joint infection. June 05, 2024 -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, announced today the completion of an oversubscribed $50 million Series D preferred stock equity financing. Zimmer Biomet led the round, joined by returning investors Johnson & Johnson Innovation – JJDC, Inc., Gideon Strategic Partners, and HM Capital. In conjunction with the financing, a representative of Zimmer Biomet will join Osteal’s Board of Directors. The proceeds of the financing will be used to advance the development of Osteal’s portfolio of therapies, including the submission of a New Drug Application (NDA) for, and accelerated commercial launch of, VT-X7 for the treatment of periprosthetic joint infection (PJI) of the hip and knee. VT-X7 has been the subject of two multicenter, randomized, controlled trials, APEX and APEX-2. APEX-2 recently met its primary endpoint and will be completed in late 2024. The study builds upon the safety and efficacy evidence obtained from APEX, a similarly designed clinical study that successfully met its primary endpoint in 2023. Both studies were designed in close consultation with the FDA, which previously granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track, and Qualified Infectious Disease Product designations. The company expects to seek FDA approval upon completion of APEX-2. “This round of financing represents an inflection point in the company’s progress towards introducing VT-X7 to the market,” said David Thompson, Chairman and Chief Executive Officer. “From the beginning, Osteal has been extremely fortunate to have the support of a world-class group of financial and strategic partners who share our vision and recognize the tremendous impact our programs will have on patient care. I am delighted to welcome Zimmer Biomet as a partner and look forward to working closely with their exemplary team.” Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation/VT-X7 irrigation system) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a seven-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com The content above comes from the network. if any infringement, please contact us to modify.

Fast TrackOrphan DrugQualified Infectious Disease Product

100 Deals associated with Tobramycin Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D02542	Tobramycin Sulfate	S01AA12 J01GB01	DB00684

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Infectious Lung Disorder	EU	PARI Pharma GmbH	18 Mar 2015
Infectious Lung Disorder	IS	PARI Pharma GmbH	18 Mar 2015
Infectious Lung Disorder	LI	PARI Pharma GmbH	18 Mar 2015
Infectious Lung Disorder	NO	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	EU	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	IS	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	LI	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	NO	PARI Pharma GmbH	18 Mar 2015
Cystic Fibrosis	AU	Phebra Pty Ltd.	17 Jul 2009
Lower Respiratory Tract Infections	US	Fresenius Kabi USA LLC	13 Jul 2004
Meningitis	US	Fresenius Kabi USA LLC	13 Jul 2004
Peritonitis	US	Fresenius Kabi USA LLC	13 Jul 2004
Sepsis	US	Fresenius Kabi USA LLC	13 Jul 2004
Skin and skin structure infections	US	Fresenius Kabi USA LLC	13 Jul 2004
Urinary Tract Infections	US	Fresenius Kabi USA LLC	13 Jul 2004
Bacterial Infections	US	Eli Lilly & Co.	11 Jun 1975

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03721328 (CTgov)	Phase 2	Prosthetic joint infection \| Juvenile Polyposis Syndrome	15	tobramycin sulfate+vancomycin hydrochloride	mfymjtluyu(grwkuvghqn) = qaqltjgxfn ewwncxilif (ltanidjits, xczfqmkzaf - hkfisexrat) View more	-	09 Dec 2021

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