CLINICAL TRIALS PROFILE FOR CEFIXIME

All Clinical Trials for cefixime

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004216 ↗	VNP20009 in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Therapy	Completed	Vion Pharmaceuticals	Phase 1	1999-08-01	RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced or metastatic solid tumors that have not responded to previous therapy.
NCT00093353 ↗	N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 1	2004-05-01	RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.
NCT00093353 ↗	N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma	Completed	Children's Hospital Los Angeles	Phase 1	2004-05-01	RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.
NCT00136656 ↗	Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old	Completed	Assistance Publique - Hôpitaux de Paris	Phase 4	2005-07-01	The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode. The investigators hypothesize that treatment with cefixime PO will allow no more renal scars than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3 years old, 6 months after the first episode. If it is true, treatment will no longer need hospitalisation and the advantages for children, families and the health system will be very important.
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	IL Sogno di Stefano	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	Regione Veneto	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
NCT00161330 ↗	Oral vs Initial Intravenous Antibiotic Treatment of Urinary Tract Infections in Children: a RCT	Terminated	University of Padova	Phase 3	2000-06-01	The main objectives of the study are 1. to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI 2. to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)

Clinical Trial Conditions for cefixime

Condition Name

Condition Name for cefixime
Intervention	Trials
Refractory Solid Tumors	2
Urinary Tract Infections	2
Infections, Bacterial	2
Relapsed Solid Tumors	2

Condition MeSH

Condition MeSH for cefixime
Intervention	Trials
Gonorrhea	6
Infections	6
Communicable Diseases	5
Infection	4

Clinical Trial Locations for cefixime

Trials by Country

Trials by Country for cefixime
Location	Trials
United States	36
France	17
Brazil	2
Italy	2
Vietnam	2

Trials by US State

Trials by US State for cefixime
Location	Trials
California	5
Texas	4
Ohio	3
North Carolina	3
Massachusetts	2

Clinical Trial Progress for cefixime

Clinical Trial Phase

Clinical Trial Phase for cefixime
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for cefixime
Clinical Trial Phase	Trials
Completed	21
Recruiting	4
Terminated	3

Clinical Trial Sponsors for cefixime

Sponsor Name

Sponsor Name for cefixime
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	7
AIDS Healthcare Foundation	2
Assistance Publique - Hôpitaux de Paris	2

Sponsor Type

Sponsor Type for cefixime
Sponsor	Trials
Other	49
NIH	9
Industry	7

Cefixime Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for Cefixime

Introduction to Cefixime

Cefixime is a third-generation cephalosporin antibiotic widely used to treat various bacterial infections, including respiratory tract infections, urinary tract infections, and gastrointestinal infections. Its broad-spectrum antibacterial properties make it a valuable option in clinical settings, especially in the face of rising antibiotic resistance.

Current Clinical Trials

Syphilis Treatment Trials

One of the significant ongoing clinical trials involves evaluating the efficacy of cefixime in treating syphilis, particularly in patients with and without HIV infection. This randomized, multisite, open-label, non-inferiority clinical trial compares cefixime (400mg orally, twice a day, for 10 days) to benzathine penicillin G (2.4 million units, intramuscularly)[1].

• Participants and Sites: The trial aims to enroll 400 participants from 9 clinical sites in the U.S. and Peru.
• Follow-Up: Participants will undergo follow-ups every 3 months for 9 months to monitor clinical outcomes and serological response (RPR titer).
• Significance: This study seeks to identify an efficacious alternative to penicillin for syphilis treatment, addressing penicillin shortages and allergies, especially in HIV-positive patients.

Pilot Study on HIV Patients with Syphilis

A pilot study published in Clinical Infectious Diseases explored the use of oral cefixime (400 mg twice daily for 10 days) to treat early syphilis in HIV patients. The study, conducted at AIDS Healthcare Foundation clinics in California, showed promising results with a high treatment response rate in the cefixime group, although it was limited by its small size and study design[4].

Market Analysis

Market Size and Forecast

The global cefixime market was valued at USD 1,200 million in 2023 and is projected to reach USD 1,850 million by 2031, growing at a CAGR of 4.9% during the forecast period 2024-2031[2].

Market Drivers

Several factors drive the growth of the cefixime market:

• Increasing Prevalence of Bacterial Infections: The rise in bacterial infections, such as urinary tract infections, respiratory tract infections, and sexually transmitted infections, due to urbanization, antibiotic resistance, and poor healthcare facilities in developing regions, increases the demand for cefixime[2].
• Growing Antibiotic Resistance Concerns: Cefixime's efficacy against certain resistant strains makes it a preferred option, and regulatory emphasis on new antibiotic strategies further boosts its market potential[2].
• Expanding Geriatric Population: The increasing susceptibility of older adults to bacterial infections and the favorable side effect profile of cefixime in the elderly contribute to its growing demand[2].
• Market Expansion in Emerging Economies: Improving healthcare infrastructure and rising awareness of infectious diseases in emerging economies drive the demand for effective treatments like cefixime[2].

Therapeutic Applications

Cefixime is primarily used to treat various infections, including:

• Respiratory Tract Infections: Conditions such as pneumonia, bronchitis, and sinusitis.
• Urinary Tract Infections: Common infections that require broad-spectrum antibiotics.
• Gastrointestinal Infections: Infections that affect the digestive system[2].

Geographic Segmentation

The cefixime market is segmented geographically, with significant markets in:

• North America: Driven by a high prevalence of bacterial infections and advanced healthcare facilities.
• Europe: Characterized by well-established pharmaceutical industries and stringent regulatory frameworks.
• Asia-Pacific: Emerging as a robust growth area due to improving healthcare infrastructure and rising awareness of infectious diseases[2].

Projections and Future Outlook

Market Growth

The cefixime market is expected to continue growing due to the increasing prevalence of bacterial infections and the need for effective antibiotic treatments. The market's CAGR of 4.9% from 2024 to 2031 indicates a steady and significant growth trajectory[2].

Research and Development

The ongoing focus on research and development in the pharmaceutical industry, particularly in addressing antibiotic resistance, will continue to drive the demand for cefixime. Larger randomized controlled studies, such as the one evaluating cefixime for syphilis treatment, will be crucial in solidifying its position as a reliable treatment option[1][4].

Emerging Markets

Emerging economies will play a significant role in the future growth of the cefixime market. As healthcare access improves and awareness of infectious diseases increases in these regions, the demand for effective antibiotics like cefixime is expected to rise[2].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating cefixime's efficacy in treating syphilis, particularly in HIV patients, and showing promising results.
• Market Size: The global cefixime market is projected to grow from USD 1,200 million in 2023 to USD 1,850 million by 2031.
• Market Drivers: Increasing bacterial infections, antibiotic resistance concerns, an expanding geriatric population, and market expansion in emerging economies drive the market.
• Therapeutic Applications: Cefixime is widely used for respiratory, urinary, and gastrointestinal infections.
• Geographic Segmentation: North America, Europe, and Asia-Pacific are key markets, with emerging economies offering significant growth opportunities.

FAQs

What is the current status of clinical trials involving cefixime for syphilis treatment?

Clinical trials are ongoing to evaluate the efficacy of cefixime compared to benzathine penicillin G in treating syphilis, especially in patients with and without HIV infection[1].

How is the global cefixime market expected to grow?

The global cefixime market is projected to grow from USD 1,200 million in 2023 to USD 1,850 million by 2031, at a CAGR of 4.9%[2].

What are the primary drivers of the cefixime market?

The primary drivers include the increasing prevalence of bacterial infections, growing antibiotic resistance concerns, an expanding geriatric population, and market expansion in emerging economies[2].

What are the main therapeutic applications of cefixime?

Cefixime is primarily used to treat respiratory tract infections, urinary tract infections, and gastrointestinal infections[2].

Which regions are significant in the cefixime market?

North America, Europe, and Asia-Pacific are key markets, with emerging economies in these regions offering significant growth opportunities[2].

What are the limitations of current clinical trials involving cefixime?

Current pilot studies are limited by their small size and study design, which reduces the precision of efficacy estimates. Larger randomized controlled studies are necessary to fully evaluate cefixime's effectiveness[4].

Sources

1. Cefixime Clinical Trial - ClinicalTrials.Veeva
2. Cefixime Market Size, Scope, Growth, Trends and Forecast - Verified Market Research
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - Biospace
4. Promising Results Seen With Cefixime for Early Syphilis - Infectious Disease Advisor
5. Global Cefixime Market Growth 2024-2030 - Market Research Reports