CLINICAL TRIALS PROFILE FOR UROPLUS DS

All Clinical Trials for UROPLUS DS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04502095 ↗	Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	Recruiting	National Cancer Institute (NCI)	Phase 4	2020-08-04	This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.
NCT04502095 ↗	Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	Recruiting	Roswell Park Cancer Institute	Phase 4	2020-08-04	This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.

Clinical Trial Conditions for UROPLUS DS

Condition Name

Condition Name for UROPLUS DS
Intervention	Trials
Bladder Carcinoma	1
Lymphoma	1
Refractory Bladder Carcinoma	1
Urinary Tract Infection	1

Condition MeSH

Condition MeSH for UROPLUS DS
Intervention	Trials
Communicable Diseases	1
Carcinoma	1
Lymphoma, AIDS-Related	1
Urinary Tract Infections	1

Clinical Trial Locations for UROPLUS DS

Trials by Country

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Trials by Country for UROPLUS DS
Location	Trials
United States	3

Trials by US State

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−

Trials by US State for UROPLUS DS
Location	Trials
New York	1
Texas	1
Florida	1

Clinical Trial Progress for UROPLUS DS

Clinical Trial Phase

Clinical Trial Phase for UROPLUS DS
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for UROPLUS DS
Clinical Trial Phase	Trials
Completed	1
Recruiting	1

Clinical Trial Sponsors for UROPLUS DS

Sponsor Name

Sponsor Name for UROPLUS DS
Sponsor	Trials
National Cancer Institute (NCI)	2
M.D. Anderson Cancer Center	1
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for UROPLUS DS
Sponsor	Trials
NIH	2
Other	2

Clinical Trials, Market Analysis, and Projections for UROPLUS DS and Similar Antibacterial Agents

Introduction to UROPLUS DS

UROPLUS DS, a formulation that includes sulfamethoxazole and trimethoprim, is a widely used antibacterial agent. This combination is effective against a variety of bacterial infections, including urinary tract infections.

Current Clinical Trials Landscape

While UROPLUS DS itself may not be in active clinical trials due to its established use, understanding the broader clinical trials landscape can provide insights into the development and testing of similar antibacterial agents.

Clinical Trial Phases

Clinical trials for new antibacterial agents typically follow a structured phase approach:

Phase I

• Focuses on safety and dosage in a small group of healthy volunteers or patients. This phase is crucial for identifying side effects and determining a safe dosage range[1].

Phase II

• Evaluates the efficacy and further assesses the safety of the drug in a larger group of patients. This phase helps in understanding the drug's effectiveness and side effects[1].

Phase III

• Involves large groups of patients to confirm the drug's effectiveness and monitor for safety. This phase is often the most complex and requires robust resources and technologies[3].

Ongoing Research in Antibacterial Agents

The development pipeline for antibacterial agents is active, driven by the need for new treatments due to antibiotic resistance. For example, the global clinical trials market, which includes trials for various therapeutic areas including infectious diseases, is projected to grow significantly. By 2028, the market is expected to reach $73.2 billion, up from $48.2 billion in 2023[3].

Market Analysis for Antibacterial Agents

Market Size and Growth

The global clinical trials market, which encompasses trials for antibacterial agents, is experiencing substantial growth. This growth is driven by increasing investments in pharmaceutical R&D and a burgeoning pipeline of drug candidates. The market is expected to grow at a CAGR of 8.7% from 2023 to 2028[3].

Regional Trends

The Asia Pacific region is emerging as a significant hub for clinical trials, including those for antibacterial agents. The region offers cost benefits, a large treatment population, and favorable government policies, making it an attractive destination for outsourcing clinical trial services[3].

Therapeutic Area Focus

Infectious diseases, including those treated by antibacterial agents like UROPLUS DS, are a key focus area in clinical trials. The increasing prevalence of antibiotic-resistant bacteria and the need for new, effective treatments drive the demand for clinical trials in this area.

Projections for Antibacterial Agents

Future of Antibacterial Treatments

The future of antibacterial treatments looks promising, with a significant number of drug candidates in the development pipeline. As of 2020, there were 17,737 drug candidates in development, and this number is expected to continue growing. This trend indicates a robust pipeline for new antibacterial agents, which could potentially replace or complement existing treatments like UROPLUS DS[3].

Challenges and Opportunities

Despite the growth, the clinical trials market faces challenges such as a shortage of skilled professionals and the complexity of conducting trials, especially for rare or niche conditions. However, advancements in biotechnology and the increasing use of Contract Research Organizations (CROs) are helping to overcome these challenges and enhance clinical trial efficiency[3].

Usage Statistics for Sulfamethoxazole and Trimethoprim

Prescription Data

Sulfamethoxazole and trimethoprim, the components of UROPLUS DS, are among the frequently prescribed medications. According to the Medical Expenditure Panel Survey (MEPS) data from 2013 to 2022, these drugs are consistently ranked high in terms of prescription frequency. The data also shows that the days supply for these prescriptions is typically around 30 days, indicating a standard treatment duration[5].

Key Takeaways

• Clinical Trials Pipeline: The pipeline for new antibacterial agents is robust, with a significant number of drug candidates in various stages of development.
• Market Growth: The global clinical trials market is expected to grow substantially, driven by increasing R&D investments and a growing pipeline of drug candidates.
• Regional Focus: The Asia Pacific region is becoming a major hub for clinical trials due to cost benefits and favorable regulatory environments.
• Usage Statistics: Sulfamethoxazole and trimethoprim remain widely prescribed, highlighting the ongoing need for effective antibacterial treatments.

FAQs

What is the current market size of the global clinical trials industry?

The global clinical trials market was valued at $48.2 billion in 2023 and is projected to reach $73.2 billion by 2028[3].

What drives the growth of the clinical trials market?

The growth is driven by increasing pharmaceutical R&D investments and a burgeoning pipeline of drug candidates, particularly in areas like biologics and biosimilars[3].

Why is the Asia Pacific region significant for clinical trials?

The Asia Pacific region offers cost benefits, a large treatment population, and favorable government policies, making it an attractive destination for outsourcing clinical trial services[3].

What are the typical phases of clinical trials for antibacterial agents?

Clinical trials for antibacterial agents typically go through Phase I (safety and dosage), Phase II (efficacy and side effects), and Phase III (large-scale efficacy and safety confirmation)[1].

How frequently are sulfamethoxazole and trimethoprim prescribed?

These drugs are among the frequently prescribed medications, with a consistent high ranking in prescription frequency data from 2013 to 2022[5].

Sources

1. Dravet Syndrome Foundation: Current Research Studies & Pipeline - Dravet Syndrome Foundation.
2. Pharmacompass: SULFAMETHOXAZOLE AND TRIMETHOPRIM | Drug Information.
3. MarketsandMarkets: Clinical Trials Market Size, Share, Trends and Revenue Forecast.
4. ClinicalTrials.gov: NCT06022822 - ClinicalTrials.gov.
5. ClinCalc: Sulfamethoxazole; Trimethoprim - Drug Usage Statistics.