CLINICAL TRIALS PROFILE FOR SUPRAX

All Clinical Trials for SUPRAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	Children's Hospital of Pittsburgh	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	University of Pennsylvania	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).
NCT01595529 ↗	The SCOUT Study: "Short Course Therapy for Urinary Tract Infections in Children"	Completed	Westat	Phase 2	2012-05-18	The SCOUT study is a multi-center, centrally randomized, double-blind, placebo-controlled non-inferiority clinical trial. 746 participants will be enrolled over a 4.5 year period. 672 will be evaluated for the study's primary outcome measure. After the first 5 days of primary care physician initiated antimicrobial therapy, patients who are afebrile and asymptomatic will then be randomized (1:1) to the standard course therapy arm of 5 more days of the same antibiotic therapy or the short course therapy arm of a placebo for 5 more days (for 10 days total). The primary objective of this study is to determine if halting antimicrobial therapy in subjects who have exhibited clinical improvement 5 days after starting antibiotic therapy (short course therapy) have the same failure rate (symptomatic UTI) through visit Day 11-14 as subjects who continue to take antibiotics for an additional 5 days (standard course therapy).

Clinical Trial Conditions for SUPRAX

Condition Name

Condition Name for SUPRAX
Intervention	Trials
Refractory Solid Tumors	2
Relapsed Solid Tumors	2
Syphilis	1
Urinary Tract Infection	1

Condition MeSH

Condition MeSH for SUPRAX
Intervention	Trials
Neoplasms	2
Communicable Diseases	1
Syphilis	1
Urinary Tract Infections	1

Clinical Trial Locations for SUPRAX

Trials by Country

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−

Trials by Country for SUPRAX
Location	Trials
United States	9
Indonesia	1

Trials by US State

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−

Trials by US State for SUPRAX
Location	Trials
Texas	2
Kentucky	2
Colorado	2
Nevada	1
California	1

Clinical Trial Progress for SUPRAX

Clinical Trial Phase

Clinical Trial Phase for SUPRAX
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	2
N/A	1

Clinical Trial Status

Clinical Trial Status for SUPRAX
Clinical Trial Phase	Trials
Completed	4
Recruiting	1

Clinical Trial Sponsors for SUPRAX

Sponsor Name

Sponsor Name for SUPRAX
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
University of Kentucky	2
University of Colorado, Denver	2

Sponsor Type

Sponsor Type for SUPRAX
Sponsor	Trials
Other	11
NIH	2
Industry	2

SUPRAX (Cefixime): Clinical Trials, Market Analysis, and Projections

Introduction

SUPRAX, also known as cefixime, is a third-generation cephalosporin antibiotic widely used to treat various bacterial infections. This article will delve into the clinical trials, adverse reactions, market analysis, and future projections for SUPRAX.

Clinical Trials and Adverse Reactions

Clinical Trial Experience

Clinical trials for SUPRAX have been extensive, involving both adult and pediatric populations. The most common adverse reactions observed in these trials include gastrointestinal events such as diarrhea, loose or frequent stools, abdominal pain, nausea, dyspepsia, and flatulence. In adult patients, diarrhea was reported in 15% of cases, with 7.2% being mild, 6.2% moderate, and 1.5% severe[1][4].

Specific Adverse Reactions

• Gastrointestinal Disorders: Diarrhea, stool changes, nausea, abdominal pain, dyspepsia, flatulence, and vomiting are common.
• Other Adverse Reactions: Headache (11%), dizziness (3%), and vomiting (2%) were also reported. Severe reactions such as pseudomembranous colitis and thrombocytopenia, though rare, have been documented[1][4].

Pediatric Patients

The incidence of adverse reactions in pediatric patients receiving the suspension formulation was generally comparable to that in adult patients receiving tablets. Mild rashes and emesis were each observed in 5% of children treated[1].

Pharmacokinetics and Drug Interactions

Age and Dosage

The pharmacokinetics of SUPRAX do not significantly differ with age. A comparative study in healthy men over 64 years and those between 18 to 35 years showed that while the mean serum concentrations were slightly higher in the elderly, these differences were not clinically significant[1].

Drug Interactions

SUPRAX does not significantly interact with most commonly used medications, including antacids, acetaminophen, heparin, phenytoin, ibuprofen, furosemide, or diazepam. However, salicylic acid (aspirin) can increase the unbound fraction of cefixime, potentially affecting its distribution and clearance[1].

Market Analysis

Global Cephalosporin Market

The global cephalosporin drugs market, which includes SUPRAX, was valued at USD 19.29 billion in 2024 and is projected to grow to USD 19.81 billion in 2025. This growth is driven by the increasing incidence of bacterial infections, rising healthcare spending, and the introduction of new treatments[3].

Regional Dominance

North America dominates the cephalosporin drugs market due to high healthcare expenditure, growing incidence of bacterial infections, and increasing FDA approvals. India is also a significant player as a major exporter and manufacturer of cephalosporin active pharmaceutical ingredients (APIs)[3].

Application Segments

The cephalosporin drug market is segmented into various infection types, with respiratory tract infections being the dominant segment. Sexually transmitted infections, such as gonorrhea, also contribute significantly to the market, with cephalosporins being recommended by health authorities like the CDC[3].

Market Projections

Growing Demand

The market for cephalosporin drugs, including SUPRAX, is expected to witness significant growth due to the rising incidence of antibiotic-resistant infections and the ongoing development of new treatments. Clinical trials focusing on multidrug-resistant antimicrobial drugs are expected to propel market growth further[3].

Future Trends

The increasing prescription of cephalosporin drugs for various infections, including respiratory and sexually transmitted diseases, will continue to drive market growth. New drug approvals, such as TEFLARO for acute bacterial skin infections, will also contribute to the market's expansion[3].

Conclusion

SUPRAX, as a part of the broader cephalosporin market, is poised for continued growth driven by increasing healthcare needs and advancements in antimicrobial treatments. While adverse reactions are a consideration, the overall efficacy and safety profile of SUPRAX make it a valuable treatment option for a range of bacterial infections.

Key Takeaways

• Clinical Trials: SUPRAX has been tested extensively, with common adverse reactions including gastrointestinal events.
• Pharmacokinetics: The drug's pharmacokinetics are not significantly affected by age, but interactions with salicylic acid can occur.
• Market Analysis: The global cephalosporin market is growing, driven by increasing healthcare spending and the need for effective antimicrobial treatments.
• Market Projections: The market is expected to continue growing due to rising demand for effective treatments against bacterial infections.

FAQs

What are the most common adverse reactions to SUPRAX?

The most common adverse reactions to SUPRAX include diarrhea, loose or frequent stools, abdominal pain, nausea, dyspepsia, and flatulence[1][4].

How does the pharmacokinetics of SUPRAX vary with age?

The pharmacokinetics of SUPRAX does not significantly differ with age, although elderly patients may have slightly higher mean serum concentrations[1].

What drives the growth of the cephalosporin drugs market?

The growth of the cephalosporin drugs market is driven by increasing healthcare spending, the rising incidence of bacterial infections, and the introduction of new treatments[3].

Which segment dominates the cephalosporin drug market?

The respiratory tract infections segment dominates the cephalosporin drug market due to the high incidence of upper and lower respiratory tract infections[3].

Are there any significant drug interactions with SUPRAX?

SUPRAX does not significantly interact with most medications, but salicylic acid can increase the unbound fraction of cefixime, affecting its distribution and clearance[1].

Sources

1. Janusinfo: Produktinformation Suprax - Janusinfo
2. DigitalCoinPrice: SUPRA Price Prediction Up to $0.25 | SUPRA Forecast
3. StraitsResearch: Global Cephalosporin Drugs Market Size, Demand, Report to 2032
4. RxList: Suprax (Cefixime): Side Effects, Uses, Dosage, Interactions, Warnings