Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
McKinsey
Dow
Colorcon
Harvard Business School

Last Updated: December 8, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR AMIKACIN SULFATE

➤ Subscribe for complete access

« Back to Dashboard

All Clinical Trials for amikacin sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000641 ↗ A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals. Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
NCT00000796 ↗ 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 (MDR Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00777296 ↗ Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) Completed Insmed Incorporated Phase 1/Phase 2 2007-02-22 A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug in close proximity to the bacterial colonies, thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa.
NCT03299452 ↗ Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor Unknown status Alphacait, LLC Phase 2 2017-01-01 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗ Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor Unknown status Haining Health-Coming Biotech Co., Ltd. Phase 2 2017-01-01 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03905642 ↗ Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase Completed Insmed Incorporated Phase 2 2009-01-08 A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of patients with CF in the U.S. are infected. Liposomal amikacin for inhalation (LAI; Arikayce™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of infected patients when delivered via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug close to the bacterial colonies (Meers, et al., 2008) (Clancy, et al., 2013), thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating patients with CF with chronic infection caused by P. aeruginosa.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for amikacin sulfate

Condition Name

Condition Name for amikacin sulfate
Intervention Trials
Cystic Fibrosis 2
HIV Infections 2
Mycobacterium Avium-intracellulare Infection 1
Tuberculosis 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for amikacin sulfate
Intervention Trials
Fibrosis 2
Cystic Fibrosis 2
HIV Infections 2
Infection 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for amikacin sulfate

Trials by Country

Trials by Country for amikacin sulfate
Location Trials
United States 12
Belgium 2
North Macedonia 2
Slovakia 2
Macedonia, The Former Yugoslav Republic of 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for amikacin sulfate
Location Trials
New York 2
Michigan 1
Illinois 1
Washington 1
Pennsylvania 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for amikacin sulfate

Clinical Trial Phase

Clinical Trial Phase for amikacin sulfate
Clinical Trial Phase Trials
Phase 2 3
Phase 1/Phase 2 1
N/A 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for amikacin sulfate
Clinical Trial Phase Trials
Completed 4
Unknown status 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for amikacin sulfate

Sponsor Name

Sponsor Name for amikacin sulfate
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 2
Insmed Incorporated 2
Alphacait, LLC 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for amikacin sulfate
Sponsor Trials
NIH 2
Industry 2
Other 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
AstraZeneca
Express Scripts
Colorcon
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.