CLINICAL TRIALS PROFILE FOR TRIMETHOPRIM

505(b)(2) Clinical Trials for Trimethoprim

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03431168 ↗	A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV	Active, not recruiting	University of Alabama at Birmingham	Phase 2	2018-03-07	More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.
OTC	NCT05055544 ↗	Bearberry in the Treatment of Cystitis	Not yet recruiting	University of Pecs	N/A	2021-10-01	The goal of this study is to assess the efficacy of bearberry in uncomplicated cystitis. Uncomplicated cystitis is a disease related to the infection of the urinary bladder. Typical symptoms are dysuria, urinary urgency, and frequent voiding of small volumes. Urinary tract infections are frequent in women, usually treated with antibiotics, since the disease is usually caused by bacteria. Fosfomycin is a frequently used antibiotic for the treatment of uncomplicated cystitis. This medicine is typically prescribed by MDs. However, since uncomplicated cystitis is quite frequent, not all patients visit the doctor when experiencing the symptoms of this disease. The use of over-the-counter products (medicines and food supplements) to alleviate the symptoms is common. One of the most frequently used medicinal plants for this purpose is bearberry. Bearberry is a medicinal plant traditionally used for the treatment of cystitis. Its use is accepted by the European Medicine Agency as traditional herbal medicinal product for relief of symptoms of mild recurrent lower urinary tract infections such as burning sensation during urination and/or frequent urination in women. Although the experience gained during the traditional use and the laboratory experiments support the supposed beneficial effect of bearberry, its clinical efficacy has not been confirmed in well-designed clinical trials in comparison with standard antibiotic therapy. In this study, the efficacy of bearberry will be assessed in comparison with fosfomycin. Premenopausal women experiencing the symptoms of uncomplicated cystitis will be randomly divided into two groups. Since it will be a double-blind trial, neither the participants nor the experimenters will know who is receiving a particular treatment. In group A, patients will receive a single dose of fosfomycin powder dissolved in water and 2 placebo tablets three times a day for 7 days. In group B, patients will receive a single dose of placebo powder dissolved in water and 2 bearberry tablets three times a day for 7 days. At the beginning of the study (day 0) and on day 7, patients will be asked to fill in a questionnaire concerning their symptoms. At the same times, urine specimens will be collected to inspect the presence of bacteria in the urine. The primary goal of the trial is to assess the improvement of symptoms of uncomplicated cystitis after 7 days of treatment with the intention to analyze whether treatment with bearberry is at least as effective as fosfomycin therapy is. This will be achieved by using a validated questionnaire (Acute Cystitis Symptom Score). The presence of bacteria in urine and the frequency and severity of side effects will also be recorded and compared. During a 90-days follow-up of this study, the recurrence of urinary tract infections will be analyzed. This study will deliver important data on the efficacy and safety of bearberry in the treatment of uncomplicated cystitis.

All Clinical Trials for Trimethoprim

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Glaxo Wellcome	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Jacobus Pharmaceutical	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000655 ↗	A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

Clinical Trial Conditions for Trimethoprim

Condition Name

Condition Name for Trimethoprim
Intervention	Trials
HIV Infections	36
Pneumonia, Pneumocystis Carinii	27
Urinary Tract Infection	11
Urinary Tract Infections	10

Condition MeSH

Condition MeSH for Trimethoprim
Intervention	Trials
Infections	41
Pneumonia	39
HIV Infections	39
Infection	36

Clinical Trial Locations for Trimethoprim

Trials by Country

Trials by Country for Trimethoprim
Location	Trials
United States	438
Canada	20
France	16
China	16
Netherlands	12

Trials by US State

Trials by US State for Trimethoprim
Location	Trials
California	34
New York	27
Pennsylvania	24
Illinois	24
Ohio	22

Clinical Trial Progress for Trimethoprim

Clinical Trial Phase

Clinical Trial Phase for Trimethoprim
Clinical Trial Phase	Trials
Phase 4	38
Phase 3	43
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Trimethoprim
Clinical Trial Phase	Trials
Completed	105
Recruiting	23
Terminated	15

Clinical Trial Sponsors for Trimethoprim

Sponsor Name

Sponsor Name for Trimethoprim
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	32
Glaxo Wellcome	8
National Cancer Institute (NCI)	7

Sponsor Type

Sponsor Type for Trimethoprim
Sponsor	Trials
Other	239
NIH	55
Industry	51

Trimethoprim: Clinical Trials, Market Analysis, and Projections

Introduction to Trimethoprim

Trimethoprim, often used in combination with sulfamethoxazole (TMP-SMX), is a widely prescribed antibiotic for various bacterial infections. Here, we will delve into the latest clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Recent Studies on TMP-SMX

While there are no recent clinical trials specifically focused on trimethoprim alone, several studies have evaluated its efficacy in combination with sulfamethoxazole. For instance, a study published in Rheumatology highlighted the effectiveness of TMP-SMX in reducing serious infections in patients treated with rituximab for granulomatosis with polyangiitis (GPA)[4].

In this study, TMP-SMX prophylaxis was associated with a significantly lower risk of serious infections, with an adjusted hazard ratio of 0.5. This indicates that TMP-SMX can be a valuable prophylactic measure in certain patient populations, although it also points to the need for careful risk-benefit assessment due to potential adverse events.

Comparative Studies

Another study compared the efficacy of TMP-SMX with azithromycin in treating enteric fever. Patients were randomized to receive either azithromycin or TMP-SMX, and the results showed that while azithromycin had a faster fever clearance time (FCT) in some cases, TMP-SMX was still effective, especially in culture-negative patients[3].

Market Analysis

Global Market Trends

The global trimethoprim market is subject to various trends and dynamics. According to market research reports, the trimethoprim market is analyzed based on manufacturers, regions, types, and applications. These reports provide insights into market trends, challenges, and opportunities within the pharmaceutical industry[5].

Manufacturers and Suppliers

The market is dominated by several key manufacturers and suppliers. These companies play a crucial role in the production and distribution of trimethoprim, influencing market prices and availability. The reports also highlight the manufacturing methods and related patents, which are essential for understanding the competitive landscape[2][5].

Market Forecast

The global trimethoprim market is forecasted to grow over the next few years, driven by increasing demand for antibiotics due to rising bacterial infections. The market research reports provide detailed forecasts up to 2030, including data on market size, growth rates, and regional dynamics[5].

Pricing and End-Users

Trimethoprim prices vary based on the region, manufacturer, and end-user. The reports provide comprehensive data on pricing trends and the downstream markets where trimethoprim is used. This includes its applications in treating urinary tract infections, respiratory infections, and other bacterial diseases[2][5].

Projections and Future Outlook

Increasing Demand for Antibiotics

The increasing incidence of bacterial infections, particularly those caused by antibiotic-resistant bacteria, is driving the demand for effective antibiotics like trimethoprim. This trend is expected to continue, making trimethoprim a crucial component in the fight against bacterial infections[1].

Regulatory Environment

Regulatory approvals and guidelines play a significant role in the market dynamics of trimethoprim. For example, the success of new antibiotics like gepotidacin, which has shown promising results in treating uncomplicated urinary tract infections, highlights the need for continuous innovation and regulatory support in the antibiotic market[1].

Challenges and Opportunities

Despite the positive outlook, the trimethoprim market faces challenges such as antibiotic resistance and the potential for adverse events. However, these challenges also present opportunities for research and development of new formulations and combination therapies that can mitigate these risks[4].

Adverse Events and Safety Considerations

Risk-Benefit Assessment

The use of TMP-SMX is associated with potential adverse events, such as acute kidney injury, which necessitates a careful risk-benefit assessment. This is particularly important in patient populations with underlying health conditions or those undergoing treatments that compromise their immune system[4].

Key Takeaways

• Clinical Efficacy: Trimethoprim, especially in combination with sulfamethoxazole, remains effective in reducing serious infections in specific patient populations.
• Market Trends: The global trimethoprim market is expected to grow due to increasing demand for antibiotics, driven by rising bacterial infections.
• Manufacturers and Suppliers: Key players in the market influence production, distribution, and pricing.
• Regulatory Environment: Continuous innovation and regulatory support are crucial for the development and approval of new antibiotics.
• Safety Considerations: Careful risk-benefit assessment is necessary due to potential adverse events associated with TMP-SMX.

FAQs

What is the current status of clinical trials involving trimethoprim?

There are no recent clinical trials specifically focused on trimethoprim alone, but studies have evaluated its efficacy in combination with sulfamethoxazole.

How does trimethoprim compare to other antibiotics in treating bacterial infections?

Trimethoprim, particularly in combination with sulfamethoxazole, is effective but may have different efficacy profiles compared to other antibiotics like azithromycin, depending on the type of infection.

What are the potential adverse events associated with trimethoprim-sulfamethoxazole?

The use of TMP-SMX is associated with potential adverse events such as acute kidney injury, necessitating careful risk-benefit assessment.

What is the forecast for the global trimethoprim market?

The global trimethoprim market is expected to grow over the next few years, driven by increasing demand for antibiotics due to rising bacterial infections.

Who are the key manufacturers and suppliers in the trimethoprim market?

The market is dominated by several key manufacturers and suppliers, whose identities and market influence can be found in detailed market research reports.

Sources

1. CIDRAP News: Trials for novel UTI antibiotic stopped early because of success. November 3, 2022.
2. Research and Markets: Trimethoprim (CAS 738-70-5) Global Market Research Report 2024.
3. Clinical Infectious Diseases: Trimethoprim-sulfamethoxazole Versus Azithromycin for the Treatment of Enteric Fever.
4. Rare Disease Advisor: Trimethoprim-Sulfamethoxazole Can Reduce Serious Infections in GPA.
5. Market Research Reports: Global Trimethoprim (TMP) Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030.