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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR BACTRIM PEDIATRIC


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

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

Clinical Trial Conditions for Bactrim Pediatric

Condition Name

Condition Name for Bactrim Pediatric
Intervention Trials
Leukemia 6
Abscess 4
Urinary Tract Infections 4
Infection 3
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Condition MeSH

Condition MeSH for Bactrim Pediatric
Intervention Trials
Infections 15
Infection 14
Communicable Diseases 12
Leukemia 8
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Clinical Trial Locations for Bactrim Pediatric

Trials by Country

Trials by Country for Bactrim Pediatric
Location Trials
United States 119
France 4
Canada 3
Peru 3
Italy 3
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Trials by US State

Trials by US State for Bactrim Pediatric
Location Trials
Texas 18
Pennsylvania 8
Ohio 8
New York 6
Michigan 6
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Clinical Trial Progress for Bactrim Pediatric

Clinical Trial Phase

Clinical Trial Phase for Bactrim Pediatric
Clinical Trial Phase Trials
Phase 4 8
Phase 3 16
Phase 2 17
[disabled in preview] 19
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Clinical Trial Status

Clinical Trial Status for Bactrim Pediatric
Clinical Trial Phase Trials
Completed 35
Terminated 7
Not yet recruiting 5
[disabled in preview] 13
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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
[disabled in preview] 7
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Sponsor Type

Sponsor Type for Bactrim Pediatric
Sponsor Trials
Other 113
Industry 17
NIH 17
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Bactrim in Pediatric Care: Clinical Trials, Market Analysis, and Projections

Introduction

Bactrim, known generically as trimethoprim-sulfamethoxazole (TMP-SMX), is a widely used antibiotic for treating various bacterial infections in children. However, its use has been under scrutiny due to rare but severe side effects. Here, we delve into the latest clinical trials, market analysis, and projections for Bactrim in pediatric care.

Clinical Trials and Safety Concerns

Revised FDA Labeling

Recent investigations by pediatric physicians at Children’s Mercy Kansas City and the University of Missouri-Kansas City School of Medicine have led to revised FDA labeling for Bactrim. The updated labeling warns medical providers to monitor patients for symptoms such as cough, shortness of breath, or rapid, shallow breathing, which could indicate acute respiratory distress syndrome (ARDS). This condition can be severe, requiring mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or even lung transplantation, and has a mortality rate of 40% in affected patients[1].

Genetic Predictors

Research by the Children’s Mercy Genomic Medicine Center has identified a specific HLA genotype associated with severe reactions to Bactrim. While this genotype is not the sole risk factor, it is a significant clue in understanding the rare but fatal reactions. The center is continuing to study genetic predictors to better identify at-risk patients[1].

Pharmacokinetics and Dosing

The Pediatric Trials Network (PTN) has conducted multicenter studies to determine appropriate dosing of TMP-SMX in infants and children. These studies, funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), aim to fill the gap in pharmacokinetics (PK) and safety data for this drug in pediatric populations[4].

Market Analysis

Global Pediatric Antibiotics Market

The global pediatric antibiotics market, which includes Bactrim, is valued at approximately $6,478.9 million in 2022 and is expected to grow at a CAGR of 2.3% from 2022 to 2030. This growth is driven by the increasing prevalence of bacterial infections among children and the adoption of inorganic growth strategies by key market players[2].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the pediatric antibiotics market, affecting production, demand, and distribution. Despite these challenges, the market is expected to recover and continue growing as normalcy returns and new collaborations and innovations emerge[2].

Market Projections

Growth Drivers

The surge in bacterial infections among children, such as urinary tract infections (UTIs), is a key driver for the pediatric antibiotics market. Additionally, collaborations between pharmaceutical companies and not-for-profit organizations, like the Global Antibiotic Research and Development Partnership (GARDP), are accelerating the development of new antibiotics, including those for pediatric use[2].

Market Size and Forecast

By 2030, the global pediatric antibiotics market is projected to reach $7,759.3 million. This growth is supported by increasing investments in research and development, particularly in the U.S. and European markets, where there is a strong focus on conducting pediatric clinical trials[2].

Pediatric Clinical Trials Market

Growth and Trends

The global pediatric clinical trials market is estimated to grow at a CAGR of 5.25% from 2025 to 2030, driven by increasing research and development investments and growing government support. Phase III trials dominate this market, but Phase I trials are expected to see the fastest growth due to the increasing focus on early-stage trials in pediatric research[3].

Regional Insights

The U.S. and European markets are expected to drive the growth of pediatric clinical trials. In the U.S., government support and private investments are fostering innovation in pediatric therapies. In Europe, the expansion of outsourcing activities among pharmaceutical companies is contributing to market growth[3].

Key Takeaways

  • Revised FDA Labeling: Bactrim's labeling has been updated to include warnings about potential severe respiratory side effects.
  • Genetic Predictors: Research is ongoing to identify genetic markers that could predict severe reactions to Bactrim.
  • Market Growth: The global pediatric antibiotics market is expected to grow at a CAGR of 2.3% from 2022 to 2030.
  • Clinical Trials: The pediatric clinical trials market is growing, with a focus on Phase I and III trials to ensure safe and effective treatments for children.
  • COVID-19 Impact: The pandemic has affected the market, but recovery and growth are anticipated as normal operations resume.

FAQs

Q: What are the recent safety concerns associated with Bactrim in pediatric patients?

A: Recent investigations have highlighted the risk of severe acute respiratory distress syndrome (ARDS) in pediatric patients treated with Bactrim, leading to revised FDA labeling[1].

Q: How are genetic predictors being used to understand reactions to Bactrim?

A: Research has identified a specific HLA genotype associated with severe reactions to Bactrim. This genotype is not the sole risk factor but is a significant clue in identifying at-risk patients[1].

Q: What is the current market size and forecast for the global pediatric antibiotics market?

A: The global pediatric antibiotics market is valued at $6,478.9 million in 2022 and is expected to reach $7,759.3 million by 2030, growing at a CAGR of 2.3%[2].

Q: How has the COVID-19 pandemic impacted the pediatric antibiotics market?

A: The pandemic has affected production, demand, and distribution, but the market is expected to recover and continue growing as normalcy returns[2].

Q: What is the significance of Phase I and III trials in pediatric clinical research?

A: Phase I trials provide essential data on safety, tolerability, and pharmacokinetics, while Phase III trials involve large populations to validate findings on a larger scale, ensuring safe and effective treatments for pediatric patients[3].

Sources

  1. Children's Mercy Research Institute - Children's Mercy physicians' investigation prompts revised FDA labeling for Bactrim, Septra.
  2. Coherent Market Insights - Pediatric Antibiotics Market Size, Trends and Forecast to 2030.
  3. Grand View Research - Pediatric Clinical Trials Market Size And Share Report, 2030.
  4. Pediatric Trials Network - Pharmacokinetics of Trimethoprim-Sulfamethoxazole and Clindamycin.

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