CLINICAL TRIALS PROFILE FOR SULFADIAZINE

All Clinical Trials for Sulfadiazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Glaxo Wellcome	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Upjohn	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.

Clinical Trial Conditions for Sulfadiazine

Condition Name

Condition Name for Sulfadiazine
Intervention	Trials
HIV Infections	6
Burns	5
Toxoplasmosis, Cerebral	5
Burn	2

Condition MeSH

Condition MeSH for Sulfadiazine
Intervention	Trials
Burns	11
Toxoplasmosis	8
HIV Infections	6
Encephalitis	5

Clinical Trial Locations for Sulfadiazine

Trials by Country

Trials by Country for Sulfadiazine
Location	Trials
United States	52
China	6
Canada	5
Brazil	3
France	2

Trials by US State

Trials by US State for Sulfadiazine
Location	Trials
New York	5
California	5
Maryland	4
Virginia	4
Illinois	4

Clinical Trial Progress for Sulfadiazine

Clinical Trial Phase

Clinical Trial Phase for Sulfadiazine
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Sulfadiazine
Clinical Trial Phase	Trials
Completed	20
Unknown status	4
Not yet recruiting	1

Clinical Trial Sponsors for Sulfadiazine

Sponsor Name

Sponsor Name for Sulfadiazine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara	3
Glaxo Wellcome	3

Sponsor Type

Sponsor Type for Sulfadiazine
Sponsor	Trials
Other	23
Industry	8
NIH	6

Sulfadiazine: Clinical Trials, Market Analysis, and Projections

Introduction

Sulfadiazine, a sulfonamide antibiotic, has been a significant player in the treatment of bacterial infections and burn wounds for several decades. This article delves into the clinical trials, market analysis, and future projections of sulfadiazine, including its various formulations such as silver sulfadiazine.

Clinical Trials and Therapeutic Evaluation

Early Clinical Trials

Sulfadiazine was first evaluated in the early 1940s for its efficacy and toxicity in human bacterial infections. Studies conducted at the Boston City Hospital involved 446 adult patients and indicated that sulfadiazine was less toxic than its analogs, sulfapyridine and sulfathiazole, and highly effective against common pathogens[1].

Recent Findings

Recent research has explored the potential of sulfadiazine beyond its traditional use as an antibiotic. For instance, studies have shown that sulfadiazine exhibits anticancer effects through its inhibitory activity against the COX/LOX pathway, suggesting its potential as an anticancer agent. Although less potent than cisplatin, sulfadiazine showed significant antiproliferative effects on HepG2 and MCF7 cell lines with lower toxicity to normal cells[3].

Market Analysis

Global Silver Sulfadiazine Creams Market

The global market for silver sulfadiazine creams, widely used in treating burn wounds, is projected to grow significantly. As of 2024, the market size was estimated at $1,762.9 million and is expected to reach $2,430.8 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.5% during the forecast period. This growth is driven by the increasing incidence of burn injuries, particularly in emerging economies, and the critical need for effective anti-burn treatments[2].

Market Segmentation

The market is segmented by type and application, with a focus on regional sales, revenue, and price analysis. The report covers key producers, sales data for main regions and countries, and competitive landscape analysis. The U.S., Canada, and European countries are among the key markets, with significant growth potential also identified in Asia-Pacific regions[2].

Challenges and Restraints

Despite the growth potential, the market faces challenges such as minor side effects associated with silver sulfadiazine, including nausea, loss of appetite, and dizziness. Additionally, the increasing price of silver, a primary raw material, is expected to impact the production costs and potentially hinder market growth[5].

Market Projections

Forecasted Market Size

By 2030, the global silver sulfadiazine creams market is expected to reach $2,430.8 million, driven by the increasing demand for effective burn treatments and the expanding healthcare infrastructure in emerging economies[2].

Regional Focus

North America, particularly the U.S. and Canada, remains a significant market for silver sulfadiazine due to its widespread use in hospitals as a powerful treatment for burns. The Asia-Pacific region is also expected to see substantial growth due to the rising incidence of burn injuries and improving healthcare facilities[5].

Competitive Landscape

The market is characterized by a competitive landscape with several key manufacturers. The report provides detailed analysis of the sales, revenue, market share, and industry ranking of these manufacturers, along with their latest development plans and competitive strategies[2].

Therapeutic Areas and Indications

Antibacterial Use

Sulfadiazine is traditionally used as an antibacterial agent, effective against a range of bacterial infections. Its use in combination with other antibiotics, such as pyrimethamine, is common in treating certain types of infections[1].

Burn Wound Treatment

Silver sulfadiazine is widely used in the treatment of partial and full-thickness burns to prevent infection. Its antimicrobial properties make it an essential component in burn care protocols[2].

Potential Anticancer Use

Recent studies suggest that sulfadiazine may have anticancer properties, particularly through its inhibitory activity against the COX/LOX pathway. This opens up new therapeutic areas for sulfadiazine, although further clinical trials are needed to fully establish its efficacy and safety in cancer treatment[3].

Regulatory and Approval Status

Approval History

Silver sulfadiazine was first approved in the U.S. on November 26, 1973. It has since been widely used in clinical settings for burn wound treatment[4].

Current Regulatory Status

The drug remains approved for use in various countries, with ongoing research and development aimed at expanding its therapeutic indications and improving its formulation.

Conclusion

Sulfadiazine, in its various forms, continues to be a valuable drug in the treatment of bacterial infections and burn wounds. The market for silver sulfadiazine creams is expected to grow significantly, driven by the increasing need for effective burn treatments. While challenges such as side effects and raw material costs exist, the potential therapeutic expansion into anticancer treatments presents new opportunities for this drug.

Key Takeaways

• Clinical Efficacy: Sulfadiazine has been proven effective in treating bacterial infections and burn wounds.
• Market Growth: The global silver sulfadiazine creams market is projected to grow at a CAGR of 5.5% from 2024 to 2030.
• Therapeutic Expansion: Recent studies suggest potential anticancer properties of sulfadiazine.
• Challenges: Minor side effects and increasing raw material costs may impact market growth.
• Regulatory Status: Silver sulfadiazine was first approved in the U.S. in 1973 and remains a widely used treatment.

FAQs

What is the primary use of sulfadiazine?

Sulfadiazine is primarily used as an antibacterial agent to treat bacterial infections and, in its silver form, to prevent infection in burn wounds.

What are the potential side effects of silver sulfadiazine?

Minor side effects include nausea, loss of appetite, and dizziness.

Is sulfadiazine being explored for other therapeutic uses?

Yes, recent studies suggest that sulfadiazine may have anticancer properties through its inhibitory activity against the COX/LOX pathway.

What is the forecasted market size for silver sulfadiazine creams by 2030?

The global market for silver sulfadiazine creams is expected to reach $2,430.8 million by 2030.

Where is the silver sulfadiazine market expected to grow the most?

The market is expected to grow significantly in North America and the Asia-Pacific region due to the increasing incidence of burn injuries and improving healthcare infrastructure.

Sources

1. FINLAND M, STRAUSS E, PETERSON OL. SULFADIAZINE: THERAPEUTIC EVALUATION AND TOXIC EFFECTS ON FOUR HUNDRED AND FORTY-SIX PATIENTS. JAMA. 1941;116(24):2641–2647. doi:10.1001/jama.1941.02820240001001
2. Global Silver Sulfadiazine Creams Market Insights, Forecast to 2030. QY Research, 2024.
3. Sulfadiazine Exerts Potential Anticancer Effect in HepG2 and MCF7 Cell Lines. MDPI, 2023.
4. Silver Sulfadiazine - Drug Targets, Indications, Patents. Synapse, 2024.
5. Silver Sulfadiazine Market Size and Trends. Coherent Market Insights, 2024.