CLINICAL TRIALS PROFILE FOR SULFATRIM

All Clinical Trials for SULFATRIM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00405704 ↗	Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)	Completed	University of North Carolina, Chapel Hill	Phase 3	2007-05-01	In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.
NCT00405704 ↗	Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2007-05-01	In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.
NCT00791505 ↗	Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation	Completed	University of Monastir	Phase 3	2002-07-01	Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiotic has any impact on outcome. Our aim was to compare the effects of the combination of trimethoprim and sulfamethoxazole and ciprofloxacin in patients treated for severe COPD exacerbation requiring mechanical ventilation.
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.

Clinical Trial Conditions for SULFATRIM

Condition Name

Condition Name for SULFATRIM
Intervention	Trials
Vesicoureteral Reflux	1
Antibiotics	1
Bladder Carcinoma	1
Chronic Obstructive Pulmonary Disease	1

Condition MeSH

Condition MeSH for SULFATRIM
Intervention	Trials
Urinary Tract Infections	2
Lung Diseases	1
Infections	1
Vesico-Ureteral Reflux	1

Clinical Trial Locations for SULFATRIM

Trials by Country

Trials by Country for SULFATRIM
Location	Trials
United States	19

Trials by US State

Trials by US State for SULFATRIM
Location	Trials
New York	2
Texas	2
Wisconsin	1
Pennsylvania	1
Oregon	1

Clinical Trial Progress for SULFATRIM

Clinical Trial Phase

Clinical Trial Phase for SULFATRIM
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SULFATRIM
Clinical Trial Phase	Trials
Completed	3
Recruiting	1

Clinical Trial Sponsors for SULFATRIM

Sponsor Name

Sponsor Name for SULFATRIM
Sponsor	Trials
National Cancer Institute (NCI)	2
University of North Carolina, Chapel Hill	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for SULFATRIM
Sponsor	Trials
Other	4
NIH	3

Sulfatrim (Sulfamethoxazole/Trimethoprim): Clinical Trials Update and Market Projection

Last updated: April 25, 2026

What is Sulfatrim, and how is it positioned commercially?

Sulfatrim is the brand name for the combination antibiotic sulfamethoxazole (SMX) + trimethoprim (TMP). It is a systemic antibacterial used for infections where the SMX-TMP combination is clinically appropriate, including (depending on country labeling) urinary tract, respiratory, and some skin and soft-tissue infections.

Commercial positioning (investment-relevant)

• Generic-dominant category: SMX-TMP is a mature, off-patent combination in most markets, driving pricing pressure and distributor-led volumes rather than innovation-led adoption.
• Formulation-driven differentiation: Supply and cost advantages often come from tablet/liquid manufacturing scale, bioequivalence execution, and country-specific regulatory approvals rather than new molecular IP.

What clinical trial activity exists for Sulfatrim (SMX/TMP)?

No complete, current clinical-trials dataset is available in the material provided in this chat. Without a verifiable trial registry pull (e.g., ClinicalTrials.gov and/or regional registries) tied specifically to the brand Sulfatrim or to the SMX/TMP combination (with status, dates, phase, indications, and endpoints), a “clinical trials update” would be incomplete and not suitable for decision-grade use.

Is there new clinical evidence that changes expected use?

No decision-grade evidence is provided here that would support a change in standard-of-care, resistance trends, or guideline status specifically attributable to Sulfatrim versus the broader SMX/TMP class.

Market analysis: what drives volume and pricing for SMX/TMP?

Even without a live trial pull, the market mechanics for SMX/TMP are well-defined:

Pricing and competitive structure

• Generic competition reduces net price and extends buyer leverage to payers and distributors.
• Tender-based procurement and formulary inclusion dominate demand stability.
• Country-to-country labeling determines which indications are eligible for reimbursement and thus shapes usable addressable volumes.

Demand drivers

• Uncomplicated bacterial infections treated in outpatient settings sustain baseline utilization.
• Antimicrobial stewardship constraints can limit SMX/TMP use in some geographies if alternative agents are favored.
• Resistance patterns affect prescribing behavior; SMX/TMP usage typically tracks local susceptibility data and guideline recommendations.

Supply-chain risk

• Commodity antibiotic manufacturing is exposed to:
  • raw material availability
  • GMP batch capacity
  • quality incidents (when they occur in the class, not necessarily brand-specific)

Market projection: what is the expected trajectory for Sulfatrim?

No numeric projection can be produced from the information available in this chat. A credible forecast requires at least one of the following that is not present here: (1) current market size by geography and segment, (2) brand or molecule volume estimates, (3) pricing benchmarks, or (4) payer/formulary penetration data.

What would matter for R&D and investment decisions in SMX/TMP now?

Because SMX/TMP is mature and generally generic, the decision variables shift from “new drug approvals” to execution and regulatory positioning:

• Formulation strategy: oral solid and pediatric liquid stability, dissolution, taste-masking (if applicable), and bioequivalence robustness.
• Geography strategy: which markets still grant meaningful pricing protection, and which are fully tender-led.
• Compliance and labeling: alignment with current local clinical guidelines to defend formulary access.
• IP strategy is usually not brand-centric: optimization work typically targets patent-protected formulations (where available), manufacturing process, or combination re-formulations, not the core actives.

Key commercial signals to monitor (actionable)

These are the operational indicators that typically predict near-term volume outcomes for SMX/TMP brands:

1. Formulary status changes (switch decisions by payers and hospital formularies)
2. Tender results and lane-level distributor pricing
3. Local susceptibility guideline updates (SMX/TMP sensitivity thresholds for key pathogens)
4. Quality or supply events tied to SMX/TMP manufacturing sites in target markets

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Key Takeaways

• Sulfatrim is a mature SMX/TMP antibiotic product in a generic-dominant category where commercialization is driven primarily by pricing, procurement, and regulatory execution rather than new clinical innovation.
• A decision-grade clinical trials update and numeric market projection cannot be produced from the information available in this chat because no verifiable, up-to-date trial registry or market-sizing dataset is provided.

FAQs

1) Is Sulfatrim still approved and used as an antibiotic brand?

Yes, Sulfatrim is an established SMX/TMP antibiotic brand name used in markets where the combination is authorized and labeled for specific infections.

2) Are there still clinical trials for the Sulfatrim brand specifically?

Clinical research usually addresses the SMX/TMP combination rather than the brand name; without a registry pull and verified trial list tied to SMX/TMP/Sulfatrim, no specific update can be stated.

3) What most affects profitability for SMX/TMP brands?

Pricing pressure from generics, tender outcomes, formulary inclusion, and supply-chain reliability typically determine margin more than incremental clinical findings.

4) Does resistance affect Sulfatrim demand?

Yes. Local pathogen susceptibility and guideline preferences influence prescribing volume and formulary positioning.

5) What is the most realistic path for value creation in this drug class?

Execution advantages in formulation quality, regulatory and labeling alignment, and geography selection for procurement markets are usually the highest-yield levers for SMX/TMP products.

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References

[1] No sources were provided in the input for clinical trials or market sizing for “Sulfatrim.”