CLINICAL TRIALS PROFILE FOR CEFADROXIL

All Clinical Trials for Cefadroxil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00405158 ↗	Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding	Completed	Karlstad University	N/A	2002-01-01	The objective of the study was to test the hypothesis that acupuncture treatment hastens recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers with 210 cases of breast inflammation (commonly called "mastitis") during breastfeeding were randomly assigned to one of three treatment groups. There were two groups where acupuncture was used and one without acupuncture. The mothers symptoms were recorded at the onset of health care contact and daily until recovery. All care interventions given, including antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk sample to test for bacterial growth. It was found that acupuncture did not shorten the women's contacts with health care services but did improve their symptoms on contact days 3 and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New Zealand where up to 100% are given antibiotics. Seven women (3.3% of those in the study) developed a breast boil and this is a similar number to a study in Australia where many more were treated by antibiotics. This could mean that many women throughout the world are given antibiotics when in fact they may recover without them. This is an important finding in relation to the fight against antibiotic resistant bacteria.
NCT00834275 ↗	Cefadroxil 500 mg Capsules Under Fasting Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2004-09-01	The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fasting conditions.
NCT00835081 ↗	Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.	Completed	Teva Pharmaceuticals USA	Phase 1	2004-09-01	The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Plastic Surgery Educational Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	The Plastic Surgery Foundation	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT01244698 ↗	Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction	Completed	Stony Brook University	Phase 4	2010-11-01	Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

Clinical Trial Conditions for Cefadroxil

Condition Name

Condition Name for Cefadroxil
Intervention	Trials
Healthy	3
Breast Implantation	1
Tuberculosis	1
Ureteral Stenosis	1

Condition MeSH

Condition MeSH for Cefadroxil
Intervention	Trials
Urinary Tract Infections	1
Infections	1
Tuberculosis, Pulmonary	1
Infection	1

Clinical Trial Locations for Cefadroxil

Trials by Country

Trials by Country for Cefadroxil
Location	Trials
United States	6
Egypt	2
Canada	2
Indonesia	1
Philippines	1

Trials by US State

Trials by US State for Cefadroxil
Location	Trials
Texas	2
Pennsylvania	1
Colorado	1
Kansas	1
New York	1

Clinical Trial Progress for Cefadroxil

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Cefadroxil
Clinical Trial Phase	Trials
Completed	11
Enrolling by invitation	1

Clinical Trial Sponsors for Cefadroxil

Sponsor Name

Sponsor Name for Cefadroxil
Sponsor	Trials
GlaxoSmithKline	2
Teva Pharmaceuticals USA	2
Plastic Surgery Educational Foundation	1

Sponsor Type

Sponsor Type for Cefadroxil
Sponsor	Trials
Other	10
Industry	6

Cefadroxil: Clinical Trials, Market Analysis, and Projections

Introduction to Cefadroxil

Cefadroxil is a first-generation cephalosporin antibiotic, introduced in the late 1970s, which has been widely used to treat various bacterial infections. It works by inhibiting the synthesis of the bacterial cell wall, leading to bacterial cell death. Here, we will delve into the clinical trials, market analysis, and future projections of cefadroxil.

Clinical Trials and Efficacy

Cefadroxil has been extensively evaluated in clinical trials for its safety and efficacy. In a comprehensive study involving 1051 patients for safety and 1030 patients for efficacy, cefadroxil demonstrated a 91.8% rate of clinical success, with 881 complete cures and 65 clinical cures[1].

• Respiratory Tract Infections: Cefadroxil showed a 97.5% clinical success rate in treating respiratory tract infections.
• Genito-Urinary Tract Infections: It achieved an 84.5% clinical success rate for genito-urinary tract infections.
• Other Infections: For other infectious diseases, cefadroxil resulted in a 99.0% clinical success rate[1].

Cefadroxil was effective against a range of pathogens, including Staphylococcus aureus, beta-haemolytic streptococci, Streptococcus pneumoniae, Escherichia coli, and Proteus mirabilis, eradicating 87% of the isolated pathogens[1].

Pharmacokinetics and Dosage

Cefadroxil has favorable pharmacokinetic properties that allow for less frequent dosing compared to other cephalosporins like cephalexin. It is absorbed similarly in both fasted and non-fasted subjects, produces sustained serum levels, and is eliminated at a relatively slow rate[1].

• Dosage Frequency: Cefadroxil can be administered once or twice daily, which significantly improves patient adherence. Studies have shown that less frequent dosing can result in up to a 30% increase in adherence[4].
• Elimination Half-Life: The serum half-life of cefadroxil ranges from 1.1 to 2 hours, which is longer than that of cephalexin. This longer half-life allows cefadroxil concentrations to remain above the minimum inhibitory concentration (MIC) for a longer period[4].

Market Analysis

The global cefadroxil market is experiencing steady growth driven by several key factors.

Increasing Demand for Antibiotics

The global demand for antibiotics is rising due to an increase in bacterial infections and the growing prevalence of antibiotic resistance. Cefadroxil, with its oral formulation and ease of administration, is particularly suited for outpatient settings[3].

Expanding Healthcare Access

In developing economies, improved healthcare access and infrastructure are contributing to the rising demand for antibiotics. Countries with expanding healthcare budgets and improving medical facilities are seeing an increased demand for cefadroxil[3].

Innovations and New Formulations

Recent innovations in the pharmaceutical sector have led to the development of extended-release tablets and combination products of cefadroxil. These new formulations aim to enhance the drug's effectiveness and reduce side effects, making it more appealing to both patients and healthcare providers[3].

Market Trends and Projections

• Global Market Size: The global cefadroxil market is projected to grow steadily from 2025 to 2031, driven by increasing demand and improving healthcare access in emerging markets[2][3].
• Regional Analysis: The market is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Asia-Pacific and Latin America are identified as regions with significant growth potential due to their expanding healthcare infrastructure[2][3].
• Competitor Analysis: Key players in the market are focusing on strategic partnerships, mergers, and acquisitions to expand their distribution networks and enhance product offerings[5].

Competitive Landscape

To gain a competitive edge in the cefadroxil market, players need to focus on several strategies:

• Innovative Formulations: Developing new and more efficient formulations, such as extended-release tablets, to improve patient compliance and reduce side effects[3].
• Global Distribution: Expanding distribution networks, especially in emerging markets, through strategic partnerships and collaborations with healthcare providers and research organizations[3][5].
• Regulatory Compliance: Adapting to regulatory reforms and ensuring compliance to maintain market presence and expand into new regions[5].

Challenges and Restraints

Despite the growth potential, the cefadroxil market faces several challenges:

• Antibiotic Resistance: The increasing prevalence of antibiotic-resistant bacteria poses a significant challenge. Research and development efforts are focused on enhancing cefadroxil's bactericidal properties to combat resistant strains[3].
• Side Effects: Cefadroxil is associated with gastrointestinal and skin-related side effects, which can impact patient adherence and overall market growth[4].

Future Projections

The cefadroxil market is expected to continue its upward trajectory driven by:

• Growing Healthcare Access: Improving healthcare infrastructure in developing economies will increase the demand for antibiotics like cefadroxil[3].
• Innovations: Ongoing research and development aimed at improving the drug's effectiveness and reducing side effects will further boost the market[3].
• Global Aging Population: The increasing global aging population, which is more susceptible to infections, will also contribute to the growing demand for cefadroxil[3].

Key Takeaways

• Clinical Success: Cefadroxil has demonstrated high clinical success rates in treating various bacterial infections.
• Pharmacokinetics: Its favorable pharmacokinetic properties allow for less frequent dosing, improving patient adherence.
• Market Growth: The global cefadroxil market is projected to grow steadily due to increasing demand for antibiotics and improving healthcare access.
• Innovations: New formulations and ongoing research to combat antibiotic-resistant bacteria are key drivers of market growth.

FAQs

What is cefadroxil used for?

Cefadroxil is used to treat a variety of bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and streptococcal pharyngitis[3].

How is cefadroxil administered?

Cefadroxil is administered orally and can be given once or twice daily due to its longer elimination half-life compared to other cephalosporins[4].

What are the common side effects of cefadroxil?

Common side effects include gastrointestinal issues such as dyspepsia, nausea, vomiting, and diarrhea, as well as skin reactions like rash, urticaria, angioedema, and pruritus[4].

Why is the demand for cefadroxil increasing?

The demand for cefadroxil is increasing due to the growing global demand for antibiotics, improving healthcare access in developing economies, and the rising prevalence of antibiotic resistance[3].

What are the future projections for the cefadroxil market?

The cefadroxil market is expected to grow steadily from 2025 to 2031, driven by increasing demand, improving healthcare access, and ongoing innovations in the pharmaceutical sector[2][3].

Sources

1. An overview of results of world-wide clinical trials with cefadroxil. PubMed.
2. Cefadroxil Market Report 2024 (Global Edition). Cognitive Market Research.
3. Cefadroxil Market Size And Projection. Market Research Intellect.
4. What is the rationale behind dosing frequency of cefadroxil for treatment of MSSA bacteremia? University of Nebraska Medical Center.
5. Cefadroxil Market: How can a player gain a competitive edge? OpenPR.

Last updated: 2025-01-03