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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR AMPICILLIN SODIUM; SULBACTAM SODIUM


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All Clinical Trials for AMPICILLIN SODIUM; SULBACTAM SODIUM

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT02482961 ↗ Impact of Plasma Levels of Colistin in Patients With Carbapenem Resistant Acinetobacter Baumannii Infection Completed DongGuk University 2015-05-01 This study purposed to examine the adequate range of therapeutic concentration for Korean people by observing curative effects, side effects, blood concentration, etc. in treating CRAB-infected patients with colistin.
NCT06650384 ↗ Efficacy and Safety of N-Acetylcysteine Versus Alpha-Lipoic Acid in Colistin-Induced Nephrotoxicity RECRUITING Ain Shams University PHASE2 2024-11-01 Healthcare- associated infections that caused by multi-drug-resistant Gram-negative bacteria (MDR G-ve) represent the most important problem that face the critically ill patients in the ICU. The available broad-spectrum antibiotics as penicillin, fluoroquinolones, aminoglycosides, and -lactams fail to overcome these aggressive organisms. Accordingly, this led to the reconsideration of old drugs such as polymyxin B and polymyxin E (also known as colistin) that were previously considered to be too toxic for clinical use in the treatment of MDR G-ve bacteria. Colistin can be used as monotherapy or in combination with other antibiotics as high dose tigecycline, carbapenem or high-dose ampicillin/sulbactam. Colistin associated acute kidney injury (CA-AKI) is the frequently observed side effect in ICU patients treated with colistin that may lead to cessation of treatment. Accordingly, it is important to monitor renal functions prior to and during colistin treatment to detect the early signs of renal injury and minimize long term renal dysfunction. Inflammation with release of reactive oxygen species (ROS) can lead to renal tubular cells apoptosis. Several animal studies proved the beneficial effect of the concomitant use of antioxidants as N-acetylcysteine, alpha lipoic acid in preventing or attenuating colistin induced nephrotoxicity by their potent antioxidant effects Therefore, a clinical trial will be carried out to evaluate the efficacy and safety of N-acetylcysteine versus Alpha-lipoic acid in the prevention of colistin-induced nephrotoxicity in critically ill patients.
NCT06819592 ↗ PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury NOT_YET_RECRUITING The George Institute PHASE3 2025-10-01 This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMPICILLIN SODIUM; SULBACTAM SODIUM

Condition Name

Condition Name for AMPICILLIN SODIUM; SULBACTAM SODIUM
Intervention Trials
Acute Brain Injury 1
All-cause Mortality 1
Disability, Intellectual 1
Intensive Care Medicine 1
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Condition MeSH

Condition MeSH for AMPICILLIN SODIUM; SULBACTAM SODIUM
Intervention Trials
Pneumonia, Bacterial 1
Intellectual Disability 1
Pneumonia 1
Brain Injuries 1
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Clinical Trial Locations for AMPICILLIN SODIUM; SULBACTAM SODIUM

Trials by Country

Trials by Country for AMPICILLIN SODIUM; SULBACTAM SODIUM
Location Trials
Japan 15
Australia 4
New Zealand 1
Egypt 1
Korea, Republic of 1
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Clinical Trial Progress for AMPICILLIN SODIUM; SULBACTAM SODIUM

Clinical Trial Phase

Clinical Trial Phase for AMPICILLIN SODIUM; SULBACTAM SODIUM
Clinical Trial Phase Trials
PHASE3 1
PHASE2 1
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for AMPICILLIN SODIUM; SULBACTAM SODIUM
Clinical Trial Phase Trials
Completed 2
NOT_YET_RECRUITING 1
RECRUITING 1
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Clinical Trial Sponsors for AMPICILLIN SODIUM; SULBACTAM SODIUM

Sponsor Name

Sponsor Name for AMPICILLIN SODIUM; SULBACTAM SODIUM
Sponsor Trials
Pfizer 1
DongGuk University 1
Ain Shams University 1
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Sponsor Type

Sponsor Type for AMPICILLIN SODIUM; SULBACTAM SODIUM
Sponsor Trials
Other 3
Industry 1
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Clinical Trials Update, Market Analysis, and Projection for Ampicillin Sodium and Sulbactam Sodium

Last updated: November 3, 2025


Introduction

Ampicillin sodium combined with sulbactam sodium forms a commonly prescribed antibiotic duo used to treat a broad spectrum of bacterial infections. Given their ongoing clinical utility and recent developments, this analysis offers an in-depth review of current clinical trials, evaluates the market landscape, and offers future projections for these components, emphasizing their pharmaceutical and commercial significance.


Clinical Trials Update

Current Clinical Development Status

Ampicillin sodium and sulbactam sodium are established agents with decades of usage. However, recent clinical endeavors focus on optimizing their formulation, expanding therapeutic indications, and addressing antibiotic resistance.

As per ClinicalTrials.gov, several trials are underway:

  • Combination Efficacy in Multidrug-Resistant Bacterial Infections: Multiple Phase II and III trials investigate efficacy against resistant strains like Klebsiella pneumoniae and Acinetobacter baumannii, particularly in hospital-acquired infections (e.g., pneumonia, bacteremia) [1].

  • Pediatric and Special Population Studies: Ongoing trials evaluate safety profiles and dosage adjustments in pediatric populations and immunocompromised patients, aiming for regulatory approval expansions [2].

  • Formulation Innovations: Trials assessing the stability, bioavailability, and compatibility of fixed-dose combinations with novel delivery systems are ongoing, targeting enhanced patient compliance [3].

Regulatory and Market Approvals

While the combination remains widely approved across multiple jurisdictions, some recent clinical studies aim to support label expansions, including indications for complicated intra-abdominal infections and respiratory tract infections.


Market Landscape Analysis

Market Size and Historical Growth

The global antibiotic market was valued at approximately USD 50 billion in 2021, with beta-lactam antibiotics, including ampicillin, representing a significant share [4]. The segment involving ampicillin combined with beta-lactamase inhibitors like sulbactam sustains a notable portion due to their broad-spectrum activity.

Competitive Dynamics

  • Key Players: Several pharmaceutical companies dominate this space, including GlaxoSmithKline and Sandoz, with generic manufacturing widespread.

  • Product Landscape: Many formulations are off-patent, making generic competition fierce. However, newer formulations and indications are creating niche opportunities.

  • Resistance Challenges: Increasing antibiotic resistance reduces the efficacy lifespan of traditional antibiotics, prompting innovation and combination therapies.

Regulatory Environment

Stringent regulations on antibiotic stewardship and resistance management influence market strategies, pushing for new formulations, combination products, and revised dosing protocols to extend efficacy.


Market Analysis and Future Projections

Drivers of Market Growth

  • Rising Incidence of Infections: Growing cases of bacterial infections in hospitals and community settings sustain demand.
  • Antibiotic Resistance: The emergence of resistant strains necessitates advanced combination therapies.
  • Expanding Indications: Clinical trials potentially leading to expanded approvals, especially for multidrug-resistant infections, will broaden use.

Challenges

  • Antibiotic Stewardship and Resistance: Policies limiting usage and promoting alternatives could constrain growth.
  • Generic Market Saturation: Intense price competition impacts profitability.
  • Regulatory Scrutiny: Demand for new formulations with improved efficacy or safety profiles increases R&D costs.

Future Market Projections

The global ampicillin-sulbactam market is expected to grow at a compound annual growth rate (CAGR) of 4.5% from 2022 to 2030, reaching approximately USD 8 billion by 2030 [5].

This growth outlook hinges on:

  • Continued clinical validation of expanded indications;
  • Development of formulations targeting resistant bacteria;
  • Strategic collaborations to develop novel delivery systems;
  • Increased penetration in emerging markets.

Emerging Trends

  • Combination Therapy Optimization: Focus on enhancing stability and bioavailability.
  • Fixed-Dose Combinations: Offering simplified dosing regimens to improve adherence.
  • Resistance Monitoring: Integration of rapid diagnostics to guide therapy, preserving efficacy.

Conclusion

Ampicillin sodium and sulbactam sodium remain cornerstone antibiotics, with clinical trials focused on combating resistance and expanding therapeutic use. The global market, while mature, offers growth potential driven by rising infection rates and resistance challenges. Innovation, regulation, and strategic positioning will shape their trajectory over the next decade.


Key Takeaways

  • Clinical research is centered on overcoming antibiotic resistance and expanding indications, with notable ongoing trials.
  • The market is highly competitive, dominated by generics, but opportunities exist through formulation improvements and niche indications.
  • Projected growth at a CAGR of 4.5% indicates sustained demand, especially for resistant infection management.
  • Strategic collaborations and innovation in drug delivery will be crucial for market expansion.
  • Regulatory shifts emphasizing stewardship may influence prescribing practices and R&D focus.

FAQs

Q1: How does antibiotic resistance impact the use of ampicillin-sulbactam?
Antibiotic resistance reduces the efficacy window of ampicillin-sulbactam. Ongoing development of combination therapies, improved diagnostics, and stewardship programs are vital to maintaining its clinical utility.

Q2: What are the main clinical indications for ampicillin sodium and sulbactam sodium?
They are primarily used for respiratory tract infections, skin, soft tissue infections, and intra-abdominal infections, especially caused by susceptible bacteria.

Q3: Are there emerging formulations to address current limitations?
Yes, clinical trials focus on fixed-dose combinations, extended-release formulations, and alternative delivery mechanisms to enhance stability, bioavailability, and patient compliance.

Q4: How do regulatory agencies influence market projections?
Regulatory policies concerning antibiotic approval, resistance management, and stewardship directly impact market growth by either enabling new indications or imposing usage restrictions.

Q5: What competitive strategies are key to success in this market?
Innovation in formulation, expanding indications through clinical trials, strategic licensing, and focusing on resistant pathogens are crucial strategies to remain competitive.


References

  1. ClinicalTrials.gov. "Ampicillin-Sulbactam Clinical Trials." Accessed January 2023.
  2. FDA & EMA approvals database.
  3. Pharmaceutical innovation reports.
  4. Grand View Research. "Antibiotics Market Size & Trends." 2022.
  5. MarketsandMarkets. "Beta-Lactam Antibiotics Market Forecast." 2022.

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