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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH


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505(b)(2) Clinical Trials for Sulfamethoxazole And Trimethoprim Single Strength

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sulfamethoxazole And Trimethoprim Single Strength

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.
NCT00000655 ↗ A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) 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.
NCT00000666 ↗ A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sulfamethoxazole And Trimethoprim Single Strength

Condition Name

Condition Name for Sulfamethoxazole And Trimethoprim Single Strength
Intervention Trials
HIV Infections 36
Pneumonia, Pneumocystis Carinii 27
Urinary Tract Infections 9
Urinary Tract Infection 8
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Condition MeSH

Condition MeSH for Sulfamethoxazole And Trimethoprim Single Strength
Intervention Trials
HIV Infections 39
Infections 38
Pneumonia 36
Infection 34
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Clinical Trial Locations for Sulfamethoxazole And Trimethoprim Single Strength

Trials by Country

Trials by Country for Sulfamethoxazole And Trimethoprim Single Strength
Location Trials
United States 396
France 16
China 16
Canada 15
Mexico 7
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Trials by US State

Trials by US State for Sulfamethoxazole And Trimethoprim Single Strength
Location Trials
California 32
New York 25
Illinois 24
Pennsylvania 20
Ohio 19
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Clinical Trial Progress for Sulfamethoxazole And Trimethoprim Single Strength

Clinical Trial Phase

Clinical Trial Phase for Sulfamethoxazole And Trimethoprim Single Strength
Clinical Trial Phase Trials
Phase 4 28
Phase 3 38
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Sulfamethoxazole And Trimethoprim Single Strength
Clinical Trial Phase Trials
Completed 87
Recruiting 15
Terminated 14
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Clinical Trial Sponsors for Sulfamethoxazole And Trimethoprim Single Strength

Sponsor Name

Sponsor Name for Sulfamethoxazole And Trimethoprim Single Strength
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 31
Glaxo Wellcome 8
National Cancer Institute (NCI) 7
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Sponsor Type

Sponsor Type for Sulfamethoxazole And Trimethoprim Single Strength
Sponsor Trials
Other 178
NIH 52
Industry 40
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Sulfamethoxazole and Trimethoprim: Clinical Trials, Market Analysis, and Projections

Introduction

Sulfamethoxazole and trimethoprim, a combination antibiotic, is widely used for treating various bacterial infections. This article delves into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Treatment of Cellulitis

A significant clinical trial compared the efficacy of cephalexin plus trimethoprim-sulfamethoxazole versus cephalexin alone in treating uncomplicated cellulitis. This multicenter, double-blind, randomized superiority trial involved 500 patients and found that the clinical cure rates were not significantly different between the two treatment groups. The study concluded that adding trimethoprim-sulfamethoxazole to cephalexin did not provide a substantial improvement in clinical cure rates for cellulitis[1].

Treatment of Undifferentiated Febrile Illness

Another study compared azithromycin with trimethoprim-sulfamethoxazole for the treatment of undifferentiated febrile illness in Nepal. This double-blind, randomized trial found that while azithromycin and trimethoprim-sulfamethoxazole were noninferior to each other for culture-confirmed enteric fever treatment, azithromycin did not show superiority over trimethoprim-sulfamethoxazole in terms of fever clearance time and treatment failure rates[3].

Pneumocystis Pneumonia Prophylaxis

A systematic review and meta-analysis examined the efficacy and safety of intermittent versus daily trimethoprim-sulfamethoxazole regimens for Pneumocystis pneumonia (PCP) prophylaxis in immunocompromised individuals. The study suggested that intermittent regimens may be more tolerable, with a 45% reduction in adverse events, while maintaining similar efficacy to daily regimens[4].

Market Analysis

Current Market Size

The sulfamethoxazole and trimethoprim market was valued at approximately USD 1.2 billion in 2022. This market is driven by the increasing prevalence of bacterial infections and the growing need for effective combination antibiotics[2].

Market Projections

The market is projected to grow significantly over the next few years. By 2030, the market is expected to reach USD 1.45 billion, growing at a compound annual growth rate (CAGR) of 6.0% from 2024 to 2030. Another projection estimates the market to reach USD 2.1 billion by 2032, with a CAGR of 3.76% during the forecast period from 2024 to 2032[2][5].

Regional Growth

The Asia-Pacific region is anticipated to be a key driver of growth, accounting for a significant portion of the total revenue. Countries in this region, along with those in Latin America, are expected to witness substantial growth due to improvements in healthcare infrastructure and increasing awareness about infection control[2][5].

Key Players

Major pharmaceutical companies such as Intas Pharmaceuticals Ltd., Macleods Pharmaceuticals Ltd., Glenmark Pharmaceuticals Ltd., Cipla Ltd., and Cadila Healthcare Ltd. are prominent players in the sulfamethoxazole and trimethoprim market. These companies are driving innovation and market growth through their product offerings and strategic expansions[5].

Market Dynamics

Factors Influencing Growth

The growth of the sulfamethoxazole and trimethoprim market is influenced by several factors, including the rising prevalence of bacterial infections, advancements in healthcare technology, and increasing investments in pharmaceutical R&D. The effectiveness of sulfamethoxazole and trimethoprim in treating a wide range of infections, including those resistant to other antibiotics, also contributes to market growth[2][5].

Technological Advancements

Advancements in machine learning, artificial intelligence, and data analytics are providing predictive insights and real-time information, enabling companies to make better and more precise decisions. New innovative techniques such as mobile surveys, social listening, and online panels are also transforming the market research sector[2].

Geographical Analysis

Regional Market Sizes

The market is segmented geographically into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to be a significant contributor to the market's growth due to its large patient base and improving healthcare infrastructure[5].

Key Takeaways

  • Clinical Efficacy: Recent clinical trials indicate that sulfamethoxazole and trimethoprim are effective in various infections but may not always offer superior outcomes when combined with other antibiotics.
  • Market Growth: The market is projected to grow significantly, driven by the increasing prevalence of bacterial infections and advancements in healthcare technology.
  • Regional Focus: The Asia-Pacific region is expected to be a key driver of growth due to its large patient base and improving healthcare infrastructure.
  • Technological Impact: Advancements in machine learning, AI, and data analytics are enhancing market research and decision-making processes.

FAQs

Q1: What is the current market size of sulfamethoxazole and trimethoprim?

The current market size of sulfamethoxazole and trimethoprim was valued at approximately USD 1.2 billion in 2022[2].

Q2: What is the projected growth rate of the sulfamethoxazole and trimethoprim market?

The market is projected to grow at a CAGR of 6.0% from 2024 to 2030, reaching USD 1.45 billion by 2030[2].

Q3: Which region is expected to drive the growth of the sulfamethoxazole and trimethoprim market?

The Asia-Pacific region is anticipated to be a key driver of growth due to its large patient base and improving healthcare infrastructure[2][5].

Q4: What are the primary factors influencing the growth of the sulfamethoxazole and trimethoprim market?

The growth is influenced by the rising prevalence of bacterial infections, advancements in healthcare technology, and increasing investments in pharmaceutical R&D[2][5].

Q5: Which companies are major players in the sulfamethoxazole and trimethoprim market?

Major players include Intas Pharmaceuticals Ltd., Macleods Pharmaceuticals Ltd., Glenmark Pharmaceuticals Ltd., Cipla Ltd., and Cadila Healthcare Ltd.[5].

Sources

  1. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure Rate Among Patients With Cellulitis: A Randomized Clinical Trial. JAMA, 2017.
  2. Sulfamethoxazole and Trimethoprim Injection Market Size and Opportunity Analysis. Verified Market Reports, 2025.
  3. Trimethoprim-sulfamethoxazole Versus Azithromycin for the Treatment of Undifferentiated Febrile Illness in Nepal. Clinical Infectious Diseases, 2020.
  4. Intermittent Versus Daily Trimethoprim/Sulfamethoxazole Regimens for Pneumocystis Pneumonia Prophylaxis. Open Forum Infectious Diseases, 2024.
  5. Sulfamethoxazole Trimethoprim Market Overall Study Report 2024-2032. Wise Guy Reports, 2024.

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