CLINICAL TRIALS PROFILE FOR KANTREX

All Clinical Trials for KANTREX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	Institute of Tropical Medicine, Belgium	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	Liverpool School of Tropical Medicine	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	Medical Research Council	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.

Clinical Trial Conditions for KANTREX

Condition Name

Condition Name for KANTREX
Intervention	Trials
Inflammatory Bowel Diseases	1
Jejunostomy Stoma	1
MDR-TB	1

Condition MeSH

Condition MeSH for KANTREX
Intervention	Trials
Intestinal Obstruction	1
Inflammatory Bowel Diseases	1
Tuberculosis, Multidrug-Resistant	1

Clinical Trial Locations for KANTREX

Trials by Country

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Trials by Country for KANTREX
Location	Trials
Mongolia	2
India	1
South Africa	1
Georgia	1
Ethiopia	1

Clinical Trial Progress for KANTREX

Clinical Trial Phase

Clinical Trial Phase for KANTREX
Clinical Trial Phase	Trials
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for KANTREX
Clinical Trial Phase	Trials
Active, not recruiting	1
Unknown status	1

Clinical Trial Sponsors for KANTREX

Sponsor Name

Sponsor Name for KANTREX
Sponsor	Trials
McMaster University	1
Institute of Tropical Medicine, Belgium	1
Liverpool School of Tropical Medicine	1

Sponsor Type

Sponsor Type for KANTREX
Sponsor	Trials
Other	6

KANTREX: Clinical Trials, Market Analysis, and Projections

Introduction

Kanamycin, marketed as KANTREX, is an aminoglycoside antibiotic used in the treatment of serious bacterial infections. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Use and Indications

KANTREX is indicated for the short-term treatment of serious infections caused by susceptible strains of microorganisms such as E. coli, Proteus species, Enterobacter aerogenes, Klebsiella pneumoniae, and others. It is often used in conjunction with other antibiotics when the causative organisms are unknown or when anaerobic organisms are suspected[1][4].

Clinical Trials and Safety Monitoring

Clinical trials and usage of KANTREX are closely monitored due to its potential for ototoxicity and nephrotoxicity. Patients receiving KANTREX must undergo regular blood, urine, hearing, and nerve tests to check for unwanted effects. Serum concentrations of the drug should be monitored to avoid potentially toxic levels, especially in patients with impaired renal function[1][4].

Ototoxicity and Nephrotoxicity

The risk of hearing loss and renal impairment is significantly higher in patients with impaired renal function or those receiving high doses or prolonged therapy. Serial audiograms and periodic measurements of blood urea nitrogen, serum creatinine, or creatinine clearance are essential to manage these risks[1].

Market Analysis

Current Market

The market for tuberculosis (TB) treatments, where KANTREX is sometimes used as a second-line agent, is largely dominated by generic products. Companies like Sandoz, which markets KANTREX, and other generics manufacturers play a significant role in this market. The TB market is highly fragmented, with several local manufacturers involved alongside large generics companies[2].

Market Share and Revenue

Historically, the TB market has seen fluctuations in sales and unit prices. For example, between 1997 and 2000, sales fell from $314 million to $275 million, while unit sales remained relatively constant, indicating a decrease in unit price. Sanofi-Aventis, Novartis (through Sandoz), and Pfizer have been among the key players in the TB market, with Sanofi-Aventis holding a significant market share[2].

Market Projections

TB Treatment Landscape

The TB treatment landscape is expected to evolve with new therapies in development. However, the growth in the TB market is likely to be offset by pressure on pricing and a slowing in the number of new TB cases. The recent increase in R&D activity could produce new advances in TB treatment within the next 5-10 years, but these are not expected to significantly impact the market for KANTREX in the short term[2].

Generic Market Dynamics

The generic nature of the TB market, including drugs like KANTREX, means that pricing pressure and competition from local manufacturers will continue. The market value is expected to remain relatively stable, with any growth likely being driven by the expansion of TB control programs and the increasing proportion of multi-drug resistant TB (MDR-TB) cases[2].

Future of KANTREX in Clinical Trials

Given the toxic hazards associated with extended administration of aminoglycosides, KANTREX is not indicated for long-term therapy. Its use is generally limited to short-term treatments, and it is not a focus of new clinical trials aimed at developing long-term or more effective TB therapies. Instead, newer agents like gatifloxacin and moxifloxacin are being explored to shorten treatment durations and reduce side effects[2].

Emerging Therapies

Newer TB therapies, such as those sponsored by the TB Alliance, the WHO, and the European Commission, are being developed to address the unmet needs of current treatments. These include shorter treatment regimens and reduced pill burdens, which could potentially replace or reduce the use of drugs like KANTREX in the future[2].

Key Takeaways

• Clinical Use: KANTREX is used for short-term treatment of serious bacterial infections, with close monitoring required due to potential ototoxicity and nephrotoxicity.
• Market Analysis: The TB market is dominated by generics, with KANTREX being a part of this fragmented market. Market growth is expected to be stable but not significant.
• Future Projections: New TB therapies are in development, which may reduce the reliance on drugs like KANTREX. However, KANTREX will likely remain a part of the treatment arsenal for specific cases.

FAQs

What are the primary indications for KANTREX?

KANTREX is indicated for the short-term treatment of serious infections caused by susceptible strains of microorganisms such as E. coli, Proteus species, and others.

What are the major risks associated with KANTREX?

The major risks include ototoxicity (hearing loss) and nephrotoxicity (kidney damage), especially in patients with impaired renal function or those receiving high doses or prolonged therapy.

How is the market for KANTREX expected to evolve?

The market is expected to remain relatively stable, with any growth driven by the expansion of TB control programs and the increasing proportion of MDR-TB cases. Newer TB therapies may reduce the reliance on KANTREX.

Are there any new clinical trials focused on KANTREX?

KANTREX is not a focus of new clinical trials aimed at developing long-term or more effective TB therapies due to its toxic hazards associated with extended administration.

What are some emerging therapies that could impact KANTREX usage?

Newer agents like gatifloxacin and moxifloxacin are being explored to shorten treatment durations and reduce side effects, potentially replacing or reducing the use of KANTREX in the future.

Sources

1. Drugs.com: Kantrex: Package Insert / Prescribing Information.
2. TB Alliance: Tuberculosis, a neglected opportunity?
3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
4. Mayo Clinic: Kanamycin (injection route) - Mayo Clinic.
5. Ricerca Alfa: Kantrex Industry Report for Global and China.