CLINICAL TRIALS PROFILE FOR BACTRIM PEDIATRIC

505(b)(2) Clinical Trials for BACTRIM PEDIATRIC

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.

All Clinical Trials for BACTRIM PEDIATRIC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000936 ↗	A Study To Test An Anti-Rejection Therapy After Kidney Transplantation	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1999-11-01	Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
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.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Eastern Cooperative Oncology Group	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00002850 ↗	Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	Completed	Gary Morrow	Phase 3	1997-03-01	RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy. PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
NCT00023231 ↗	Pediatric Kidney Transplant Without Calcineurin Inhibitors	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2001-02-01	The purpose of this study is to see the effect of using drugs other than calcineurin inhibitors to improve the rate of kidney transplant failure. Kidney transplantation can help children with end-stage kidney disease. However, it has been difficult to find treatment for donor graft rejection that does not have a lot of side effects. Researchers hope to find treatments (immunosuppressants) with fewer side effects. One approach is to avoid using calcineurin inhibitors and to try a new drug known as sirolimus instead. Another is to use steroids less often. This study will test whether using sirolimus, fewer steroid treatments, MMF, and certain antibodies will improve long-term graft survival in children receiving kidney transplants from living donors.

Clinical Trial Conditions for BACTRIM PEDIATRIC

Condition Name

Condition Name for BACTRIM PEDIATRIC
Intervention	Trials
Leukemia	6
Abscess	4
Urinary Tract Infections	4
Lymphoma	3

Condition MeSH

Condition MeSH for BACTRIM PEDIATRIC
Intervention	Trials
Infections	15
Infection	14
Communicable Diseases	12
Leukemia	8

Clinical Trial Locations for BACTRIM PEDIATRIC

Trials by Country

Trials by Country for BACTRIM PEDIATRIC
Location	Trials
United States	120
France	4
Peru	3
Italy	3
Canada	3

Trials by US State

Trials by US State for BACTRIM PEDIATRIC
Location	Trials
Texas	18
Ohio	9
Pennsylvania	8
New York	6
Michigan	6

Clinical Trial Progress for BACTRIM PEDIATRIC

Clinical Trial Phase

Clinical Trial Phase for BACTRIM PEDIATRIC
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	8

Clinical Trial Status

Clinical Trial Status for BACTRIM PEDIATRIC
Clinical Trial Phase	Trials
Completed	35
Terminated	7
Withdrawn	5

Clinical Trial Sponsors for BACTRIM PEDIATRIC

Sponsor Name

Sponsor Name for BACTRIM PEDIATRIC
Sponsor	Trials
M.D. Anderson Cancer Center	11
National Institute of Allergy and Infectious Diseases (NIAID)	7
National Cancer Institute (NCI)	5

Sponsor Type

Sponsor Type for BACTRIM PEDIATRIC
Sponsor	Trials
Other	115
NIH	17
Industry	17

Last updated: April 25, 2026

BACTRIM PEDIATRIC (trimethoprim-sulfamethoxazole): Clinical Trial Update, Market Analysis, and Projection

What is BACTRIM PEDIATRIC and how is it used?

BACTRIM PEDIATRIC is a pediatric formulation of trimethoprim-sulfamethoxazole (TMP-SMX), an oral antibacterial combination used for a range of infections. TMP-SMX dosing and indications depend on organism and clinical syndrome, and the drug’s regulatory positioning is tied to established antimicrobial use cases rather than a single disease-specific breakthrough program.

Regulatory class and IP posture (practical view)

• TMP-SMX is a long-established generic antimicrobial worldwide.
• The “BACTRIM PEDIATRIC” brand is a product formulation/brand within an active ingredient class that has largely exited meaningful patent exclusivity in major markets.
• Commercial outcomes therefore hinge on competitive generic pricing, antibiotic stewardship demand, and formulary access, not novel molecular patent life.

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What clinical trial updates apply to BACTRIM PEDIATRIC?

BACTRIM PEDIATRIC does not represent a distinct, late-stage, molecule-level development program. Clinical evidence is anchored to the TMP-SMX active ingredient’s broad clinical use record, and to formulation-specific packaging/labeling rather than independent late-stage trials.

Clinical trial reality for TMP-SMX (relevant to pediatric use)

• Pediatric practice relies on established dosing and safety efficacy evidence accumulated over decades for TMP-SMX.
• Contemporary research activity is typically concentrated in:
  • Comparative effectiveness of antibiotic strategies (including TMP-SMX) for common pediatric infections.
  • Safety, dosing optimization, and resistance-driven outcomes across settings.
  • Trials that evaluate stewardship pathways rather than brand-level product performance.

What this means for a “BACTRIM PEDIATRIC clinical trial update”

• There is no basis to claim a specific, brand-scoped Phase 3 or Phase 2 readout for BACTRIM PEDIATRIC as an independent development asset.
• Any “update” in the public domain is expected to be indirect (TMP-SMX clinical literature and guideline integration), not a brand-specific pipeline milestone.

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How does the market for TMP-SMX pediatric therapy look today?

The pediatric TMP-SMX market is shaped by four forces:

1. Generic dominance and price compression

   • TMP-SMX is widely available as generics globally.
   • Brand differentiation in pediatrics is largely limited to formulation convenience (pediatric suspension), labeling, supply reliability, and contracted formulary access.

2. Antibiotic stewardship and guideline-driven substitution

   • TMP-SMX use is sensitive to guideline recommendations and local susceptibility patterns.
   • Stewardship pressure reduces empirical use in some syndromes when alternatives are preferred and resistance patterns are unfavorable.

3. Resistance and indication mix

   • TMP-SMX has retained utility in select infections where susceptibility remains favorable.
   • Market demand shifts when resistance to TMP-SMX increases or when resistance trends change by geography.

4. Formulary and payer contracting

   • Pediatric liquid antibiotics are frequently subject to formulary control due to utilization and budget impact.

Market segmentation (commercially actionable)

• Core pediatric oral antibiotic demand for infections where TMP-SMX is an accepted option.
• Institutional and outpatient pediatrics where suspension formulations support adherence and dosing flexibility.
• Acute care vs. chronic/relapsing use patterns depend on local infection epidemiology (for example, recurrent infections where TMP-SMX is guideline-supported).

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What are the key drivers and headwinds for BACTRIM PEDIATRIC?

Drivers

• Stable pediatric need for oral antibiotics where TMP-SMX is indicated.
• Formulation convenience (liquid/pediatric administration) and stable pediatric dosing practices.
• Contracted access through pediatric formularies where BACTRIM pediatric is stocked.

Headwinds

• Generic substitution pressure remains the central pricing risk.
• Antibiotic stewardship lowers empirical usage where TMP-SMX is not first-line.
• Rising resistance in key pathogens can reduce relative preference.
• Regulatory or payer tightening around antibiotic selection can shift utilization toward alternatives.

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Market projection: What is a realistic outlook for BACTRIM PEDIATRIC (2026-2030)?

A projection for BACTRIM PEDIATRIC is best modeled as a brand share and pricing story inside a generic drug class, not a molecule growth story.

Projected scenario framework (directional, for planning)

• Base case: flat-to-low growth in unit demand for pediatric TMP-SMX (driven by population and infection incidence), with brand revenue growing slowly if BACTRIM maintains formulary position. Pricing is likely to be pressured by generics.
• Downside case: utilization declines due to stewardship and resistance-led preference shifts; brand revenue contracts even if total pediatric antibiotic volume remains steady.
• Upside case: favorable contracting or stronger persistence in pediatric suspension preference supports modest share retention; resistance patterns stabilize for key infections.

Implication for business planning

• Revenue growth is most likely to come from share retention and contracted formulary access, not from therapeutic expansion.
• Investment prioritization should focus on:
  • Supply reliability and pediatric supply continuity.
  • Payer contracting and formulary navigation.
  • Labeling and compliance support tied to pediatric administration and dosing accuracy.

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How should investors and R&D teams evaluate BACTRIM PEDIATRIC vs. the TMP-SMX class?

Key decision lens

• Treat BACTRIM PEDIATRIC as a commercial brand within a mature, generic class.
• The competitive map is defined by suspension availability, pricing, and contracting rather than proprietary drug performance.

Practical benchmark metrics

• Share of pediatric oral TMP-SMX suspension category.
• Net price erosion versus generic basket.
• Formulary inclusion across top pediatric health systems.
• Stock-out rate and distribution performance (often decisive in pediatric liquid antibiotics).

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Key Takeaways

• BACTRIM PEDIATRIC is a pediatric TMP-SMX brand, not a standalone pipeline asset; clinical updates are expected to reflect TMP-SMX’s established evidence base, not brand-specific Phase 2/3 milestones.
• Market outlook is driven by generic competition, formulary access, antibiotic stewardship, and resistance patterns, not by innovation-led demand expansion.
• Projections (2026-2030) should be modeled as share and price dynamics within a mature generic category: base case is typically low growth or flat revenue with higher risk of decline under resistance or stewardship shifts.

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FAQs

1) Does BACTRIM PEDIATRIC have a distinct late-stage development program?

No. BACTRIM PEDIATRIC is a pediatric formulation of an established antimicrobial; brand value depends on commercialization and access within the generic TMP-SMX market.

2) Are current clinical trials likely to generate label expansion for the brand?

Publicly visible trial activity for TMP-SMX is generally not brand-scoped and is more often tied to treatment strategies, comparative outcomes, or stewardship rather than brand-specific pediatric formulation trials.

3) What most affects demand for pediatric TMP-SMX?

Formulary decisions, antibiotic stewardship protocols, and local resistance patterns in pediatric pathogens.

4) What is the biggest commercial risk to BACTRIM PEDIATRIC?

Generic substitution and net price erosion, which can outweigh modest changes in underlying infection volumes.

5) Where can growth realistically come from?

From retaining or expanding formulary share for pediatric oral suspension use and maintaining favorable payer contracting rather than from new clinical differentiation.

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References

[1] FDA. Drug approvals and labeling information for trimethoprim-sulfamethoxazole products (BACTRIM/BACTRIM PEDIATRIC listings and prescribing information). (Accessed via FDA databases).
[2] Global databases for clinical trial records and study identifiers for TMP-SMX (search results for “trimethoprim-sulfamethoxazole” pediatric). (Accessed via clinicaltrials.gov and related registries).
[3] Professional guideline documents addressing TMP-SMX use in pediatric infections and resistance context (pediatric infectious disease guidance). (Accessed via society and guideline publications).