CLINICAL TRIALS PROFILE FOR UNASYN

All Clinical Trials for UNASYN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01118403 ↗	Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients	Withdrawn	Hospital Pablo Tobón Uribe	Phase 4	2011-03-01	This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment. Our hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.
NCT01189487 ↗	The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)	Completed	Pfizer	Phase 3	2010-10-01	Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
NCT00879190 ↗	Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis	Completed	Stanford University	Phase 2/Phase 3	2009-05-01	Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat common and is routinely treated with antibiotics given to the mother both before and after the baby is born. Currently it is not known what is the best choice of antibiotics to treat this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if one is better than the other at treating and preventing bad outcomes from chorioamnionitis in women and babies.
NCT00760006 ↗	Preventing Complications in Cleft Palate Repair With Antibiotics	Completed	Children's Hospital of Pittsburgh	Phase 2	2008-05-01	The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to - decrease the incidence of surgical sight infections - speed the progression of postoperative healing - improve the final quality of wound healing achieved - decrease the rate of palatal fistula formation
NCT00760006 ↗	Preventing Complications in Cleft Palate Repair With Antibiotics	Completed	Joseph Losee	Phase 2	2008-05-01	The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to - decrease the incidence of surgical sight infections - speed the progression of postoperative healing - improve the final quality of wound healing achieved - decrease the rate of palatal fistula formation

Clinical Trial Conditions for UNASYN

Condition Name

Condition Name for UNASYN
Intervention	Trials
Infection	1
Jaw Fractures	1
Lung Abscess	1
Open Fracture	1

Condition MeSH

Condition MeSH for UNASYN
Intervention	Trials
Pneumonia	4
Fractures, Bone	2
Lung Abscess	1
Jaw Fractures	1

Clinical Trial Locations for UNASYN

Trials by Country

+

−

Trials by Country for UNASYN
Location	Trials
Japan	15
United States	4
Colombia	1

Trials by US State

+

−

Trials by US State for UNASYN
Location	Trials
Texas	1
Ohio	1
California	1
Pennsylvania	1

Clinical Trial Progress for UNASYN

Clinical Trial Phase

Clinical Trial Phase for UNASYN
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for UNASYN
Clinical Trial Phase	Trials
Completed	4
Recruiting	1
Terminated	1

Clinical Trial Sponsors for UNASYN

Sponsor Name

Sponsor Name for UNASYN
Sponsor	Trials
Pfizer	2
Sheba Medical Center	1
Joseph Losee	1

Sponsor Type

Sponsor Type for UNASYN
Sponsor	Trials
Other	12
Industry	2

UNASYN: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to UNASYN

UNASYN is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium. This formulation is designed for intravenous and intramuscular administration, making it a versatile treatment option for various bacterial infections[5].

Clinical Trials and Efficacy

Pediatric Clinical Trials

A significant clinical trial conducted in pediatric patients evaluated the safety and efficacy of UNASYN for the treatment of skin and skin structure infections. The trial involved 99 pediatric patients, with 60 receiving UNASYN and 39 receiving cefuroxime. The results showed similar clinical outcomes between the two groups, with 85% of UNASYN-treated patients and 87% of cefuroxime-treated patients achieving clinical success. This study supported the efficacy and safety of UNASYN in pediatric patients[1][4].

Adult Clinical Trials

In adult populations, UNASYN has been tested in various clinical settings to treat infections such as intra-abdominal infections, gynecological infections, and skin and skin structure infections. These trials have consistently demonstrated that UNASYN is effective against a broad spectrum of bacteria, including those resistant to other beta-lactam antibiotics due to the presence of sulbactam[3][5].

Pharmacokinetics and Pharmacodynamics

Clinical trials have also focused on the pharmacokinetics of UNASYN. The drug achieves peak serum concentrations of ampicillin and sulbactam shortly after intravenous infusion, with mean peak serum levels ranging from 109 to 150 mcg/mL for ampicillin and 48 to 88 mcg/mL for sulbactam. The mean serum half-life of both drugs is approximately 1 hour in healthy volunteers. This pharmacokinetic profile supports the drug's efficacy in treating bacterial infections[2][3].

Market Analysis

Current Market Position

UNASYN is a well-established antibiotic in the market, particularly valued for its broad-spectrum antibacterial activity and its ability to inhibit beta-lactamases. It competes in a crowded antibiotic market but holds a significant position due to its efficacy against beta-lactamase-producing bacteria, which are increasingly resistant to other antibiotics.

Market Trends

The global antibiotic market is driven by the increasing prevalence of antibiotic-resistant bacteria and the need for effective treatments. UNASYN benefits from this trend as it remains effective against many strains that are resistant to other antibiotics. However, the market is also influenced by the push for antibiotic stewardship and the development of new antibiotics, which can impact the usage and sales of existing drugs like UNASYN.

Competitive Landscape

UNASYN competes with other broad-spectrum antibiotics and beta-lactamase inhibitors. Key competitors include other combination antibiotics like piperacillin/tazobactam and ticarcillin/clavulanate. The competitive landscape is dynamic, with ongoing research and development aimed at creating new antibiotics and combination therapies.

Market Projections

Growth Potential

The market for antibiotics, including UNASYN, is expected to grow due to several factors:

• Increasing Resistance: The rise in antibiotic-resistant bacteria will continue to drive the demand for effective treatments like UNASYN.
• Aging Population: An aging population is more susceptible to infections, which will increase the demand for antibiotics.
• Emerging Markets: Growing healthcare infrastructure in emerging markets will expand the reach and demand for antibiotics like UNASYN[3].

Challenges and Opportunities

Despite the growth potential, there are challenges to consider:

• Antibiotic Stewardship: Efforts to reduce antibiotic misuse and overuse could impact sales.
• Regulatory Environment: Stricter regulations on antibiotic use and development can affect market dynamics.
• Innovation: Continuous innovation in antibiotic development could lead to new competitors.

However, opportunities also exist:

• Expanding Indications: Research into new indications for UNASYN could expand its market.
• Combination Therapies: Developing new combination therapies involving UNASYN could enhance its market position.
• Global Health Initiatives: Participation in global health initiatives aimed at combating antibiotic resistance could increase visibility and demand for UNASYN.

Safety and Adverse Effects

Common Adverse Effects

Clinical trials and post-marketing surveillance have identified several common adverse effects associated with UNASYN, including gastrointestinal disturbances, skin rashes, and allergic reactions. Serious adverse effects are less common but can include severe allergic reactions, Clostridioides difficile-associated diarrhea, and changes in liver function tests[3][4].

Drug Interactions

UNASYN can interact with other medications, such as probenecid, which can increase and prolong blood levels of ampicillin and sulbactam. It is also important to avoid co-administration with aminoglycosides due to the potential for inactivation of aminoglycosides by the ampicillin component of UNASYN[3].

Patient and Healthcare Provider Considerations

Patient Information

Patients receiving UNASYN should be aware of the potential for false positive glucose tests in urine due to high concentrations of ampicillin. They should also be informed about the possibility of transient changes in estrogen levels during pregnancy and the importance of reporting any adverse effects[4].

Healthcare Provider Guidelines

Healthcare providers should use UNASYN only for infections proven or strongly suspected to be caused by susceptible bacteria. They should also consider local epidemiology and susceptibility patterns when selecting or modifying antibacterial therapy. Regular monitoring for signs of adverse effects and drug interactions is crucial[3].

Key Takeaways

• Efficacy: UNASYN has demonstrated efficacy in treating various bacterial infections, including those caused by beta-lactamase-producing bacteria.
• Pharmacokinetics: The drug achieves rapid peak serum concentrations and has a mean serum half-life of approximately 1 hour.
• Market Position: UNASYN holds a significant position in the antibiotic market due to its broad-spectrum activity.
• Growth Potential: The market for UNASYN is expected to grow driven by increasing antibiotic resistance and an aging population.
• Safety and Adverse Effects: Common adverse effects include gastrointestinal disturbances and skin rashes, with serious effects being less common.

FAQs

Q: What is UNASYN used for?

UNASYN is used to treat various bacterial infections, including skin and skin structure infections, intra-abdominal infections, and gynecological infections.

Q: How does UNASYN work?

UNASYN works by combining ampicillin, a semisynthetic antibacterial, with sulbactam, a beta-lactamase inhibitor. Sulbactam extends the antibacterial spectrum of ampicillin to include bacteria normally resistant to it.

Q: What are the common adverse effects of UNASYN?

Common adverse effects include gastrointestinal disturbances, skin rashes, and allergic reactions.

Q: Can UNASYN be used in pediatric patients?

Yes, UNASYN has been shown to be safe and effective in pediatric patients for the treatment of skin and skin structure infections.

Q: How does UNASYN interact with other medications?

UNASYN can interact with probenecid, increasing and prolonging blood levels of ampicillin and sulbactam. It should not be co-administered with aminoglycosides due to potential inactivation.

Sources

1. Pfizer Medical Information - UNASYN Clinical Studies
2. Pfizer Medical Information - UNASYN
3. Pfizer Labeling - UNASYN
4. Pfizer Medical Information - UNASYN Patient Information
5. Drugs.com - UNASYN Package Insert