Delving into the Latest Updates on Ampicillin Sodium/Sulbactam Sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ampicillin Sodium and Sulbactam Sodium, Ampicillin/Sulbactam, Sulbactam sodium/Ampicillin Sodium

+ [27]

Target

PBPs x β-lactamase

Action

inhibitors

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), β-lactamase inhibitors(Beta Lactamase inhibitors)

Therapeutic Areas

Infectious DiseasesNervous System DiseasesDigestive System Disorders+ [4]

Active Indication

Pneumonia, PneumococcalCystitisLung Abscess+ [12]

Inactive Indication

Community Acquired Pneumonia

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Japan, Inc.

Nichi-Iko Pharmaceutical Co., Ltd.

Pfizer Inc.

+ [5]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (31 Dec 1986),

Bone and joint infectionsCentral Nervous System InfectionsGynecological infection+ [6]

Regulation-

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Structure/Sequence

Molecular FormulaC24H30N4Na2O9S2

InChIKeyMWBFWOYZSJLWIO-UBWQYZJSSA-N

CAS Registry117060-71-6

CRAB infections in ICUs are on the rise, leading to higher morbidity, mortality, and healthcare costs due to resistance to most antibiotics, including carbapenems. The main resistance mechanisms include carbapenemases, efflux pumps, and changes in the bacterial cell wall.
Current treatments include polymyxins (Colistin, Polymyxin B), which are effective but can lead to resistance, aminoglycosides (Amikacin, Gentamicin), which are limited by resistance, and tetracyclines (Tigecycline, Eravacycline), which are effective against CRAB. Fosfomycin is effective in combination treatments, and combination therapy (e.g., colistin with sulbactam, fosfomycin, or eravacycline) can enhance outcomes.
Previous research shows promise for combination therapies, improving treatment efficacy and reducing mortality. New regimens are being studied to find optimal combinations. Individualized dosing is crucial, considering patient-specific factors like age, weight, and renal function. Adjustments depend on the infection site and comorbidities.
Strict infection control and antimicrobial stewardship programs (ASPs) are essential. ASPs focus on optimizing antibiotic use and reducing resistance through education and surveillance. Future directions include continued research for new drugs or combinations and strategies to overcome resistance and improve treatment efficacy.
Study goals include achieving negative samples after 10 days of therapy, 30-day survival, discharge rates, reduced SOFA scores, and improved clinical and radiological findings. A randomized study will compare colistin combined with fosfomycin, ampicillin/sulbactam, and eravacycline.
In summary, treating CRAB infections is complex, requiring combination therapy, individualized dosing, and strict infection control measures.

Start Date30 Jan 2025

Sponsor / Collaborator-

NCT06735703

/ Not yet recruitingNot ApplicableIIT

Incidince of PROM with GBS Infection and Prophylaxis Against It

To investigate incidince of prom with GBS infection and role of prophylaxis against it

Start Date25 Dec 2024

Sponsor / Collaborator

Assiut University

NCT05922124

/ RecruitingPhase 4IIT

Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)

Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.

Start Date01 Sep 2024

Sponsor / Collaborator

Rambam Health Care Campus

[+2]

100 Clinical Results associated with Ampicillin Sodium/Sulbactam Sodium

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100 Translational Medicine associated with Ampicillin Sodium/Sulbactam Sodium

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100 Patents (Medical) associated with Ampicillin Sodium/Sulbactam Sodium

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372

Literatures (Medical) associated with Ampicillin Sodium/Sulbactam Sodium

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Frequency of CIT, EBC and DHA flocks (families) of AmpC beta-lactamases in clinical isolates of Klebsiella pneumoniae collected from hospitalized patients in North of Iran

Article

Author: Samadi, Mehdi ; Goli, Hamid Reza ; Gholami, Mehrdad ; Elahi, Faezeh ; Betiar, Fatemeh ; Karimbakhsh, Mohammad

BACKGROUND:

Klebsiella pneumoniae exhibits a marked propensity for acquiring beta-lactam resistance genes. Among these, AmpC beta-lactamases are able to hydrolyze a broad spectrum of antibiotics including first- through third-generation cephalosporins, cephamycins, and aztreonam. The CIT, EBC, and DHA families are among the most clinically significant plasmid-mediated AmpC variants in this pathogen. Consequently, this study aimed to investigate the prevalence of genes encoding these specific enzymes among clinical isolates of K. pneumoniae in northern Iran.

METHODS:

One hundred clinical isolates were collected from hospitalized patients and identified using standard microbiological and biochemical assays. The antimicrobial resistance profile of each isolate was determined via the disk agar diffusion method. Subsequently, PCR test was employed to detect the presence of the bla_CIT, bla_EBC, and bla_DHA genes.

RESULTS:

The mean age of the patients (58 females and 42 males) was 50.31 years. Isolates were sourced from patients in general (41%), pediatric (45%), burn (7%), and infectious (7%) hospitals. The primary specimen sources were urine (64%), blood (10%), tissue (15%), wound (7%), and sputum (4%). The highest prevalence of resistance (93%) was observed against ampicillin-sulbactam, whereas 73% of isolates remained susceptible to ertapenem.

CONCLUSION:

The high ampicillin-sulbactam resistance represents a serious concern for the management of hospital-acquired infections. Furthermore, while the presence of the investigated bla_CIT, bla_EBC, and bla_DHA genes did not show a statistically significant correlation with resistance to most tested antibiotics, their detection remains of potential clinical importance due to the risk of horizontal gene transfer to other bacterial species.

02 Feb 2026·JOURNAL OF APPLIED MICROBIOLOGY

Clinical, microbiological, and genomic characterization of carbapenem-resistant Gram-negative bacteria in bloodstream infection: a multi-center study in Ecuador

Article

Author: Moreno, Cristina ; Zurita-Salinas, Camilo ; Zurita, Jeannete ; Herrera-Yela, Andrés ; Solís, María Belén ; Romero, Juan José ; Sevillano, Gabriela

Abstract:

Aims:

To evaluate the diversity, prevalence, and phenotypic and genotypic characteristics of carbapenem-resistant Gram-negative bacteria (CR-GNB) causing bloodstream infections, and assess the mechanisms driving their dissemination through a multi-center study in nine hospitals of Ecuador.

Methods and results:

Between November 2021 and May 2022, 297 Gram-negative bacteria (GNB) were isolated from 273 patients across nine hospitals in Ecuador. Genotypic characterization of carbapenem-resistant GNB from blood cultures was performed by whole genome sequencing (WGS). CR-GNB accounted for 18.8% (56/297), predominantly Klebsiella pneumoniae (41.1%), followed by Enterobacter cloacae complex (16.1%), Acinetobacter baumannii (12.5%), and Pseudomonas aeruginosa (7.1%). CR-GNB showed high resistance to cephalosporins (80%–95%), piperacillin-tazobactam (85.7%), ampicillin-sulbactam (91.1%), and ciprofloxacin (78.6%). Genomic analysis revealed carbapenemase genes blaKPC-2 (most frequent), blaNDM-1, and blaOXA-181 across high-risk clones (e.g. K. pneumoniae ST307, ST258, ST147; A. baumannii ST1187). Carbapenemase genes were plasmid-borne (IncA/C, IncM, IncN, IncF, IncHI2, IncX3, and non-typeable) and associated with transposons (Tn4401, Tn125, and Tn3). Also, blaVIM-2 in Pseudomonas spp. was plasmid- and chromosomally encoded.

Conclusions:

Our findings demonstrate a high burden of CR-GNB, primarily due to K. pneumoniae and E. cloacae complex. Furthermore, the widespread distribution of blaKPC-2, blaNDM-1, and blaOXA-181 in high-risk clones, coupled with the frequent plasmid- and transposon-mediated mobilization of these genes, highlights the crucial role of horizontal gene transfer in the dissemination of resistance.

01 Feb 2026·THERAPEUTIC DRUG MONITORING

Population Pharmacokinetic Models of Ampicillin–Sulbactam Among Adult Patients with Infectious Diseases: A Systematic Review

Review

Author: Yin, Teh Sin ; Sheikh Ghadzi, Siti Maisharah ; Yahaya, Noorfatimah ; Poornachandran, Mohananasunthari ; Harun, Sabariah Noor

Background::

Ampicillin–sulbactam is the first-line treatment for pneumonia, aspiration pneumonia, and infections caused by Acinetobacter baumannii . Several population pharmacokinetic (PK) studies have evaluated the intravenous administration of ampicillin–sulbactam in adults. This systematic review aimed to compare published PK models and identify covariates influencing ampicillin–sulbactam PKs.

Methods::

A comprehensive literature search was conducted using PubMed and Scopus from inception to March 2025. Relevant articles from reference lists were also incorporated. This review included all population PK models of ampicillin–sulbactam administered intravenously in adult patients with various health conditions.

Results::

Five studies were reviewed, using a two-compartment model for ampicillin–sulbactam. The PK profiles of ampicillin and sulbactam were found to be similar, with comparable CL and V d across all selected studies. Ampicillin clearance ranged from 5.58 to 11.03 L/h, whereas sulbactam clearance ranged from 4.79 to 10.50 L/h. The volume of distribution varied from 11.78 to 19.12 L for ampicillin and from 13.89 to 16.77 L for sulbactam. Interindividual variability of ampicillin–sulbactam PK parameters varied across the included studies. Creatinine clearance (CLcr), serum creatinine (SCr), body surface area, body weight, and heart failure were found to be significant covariates affecting the PK parameters.

Conclusions::

Ampicillin–sulbactam clearance is primarily influenced by renal function (CLcr and SCr) and disease status. None of the studies performed external validation of the developed PK model. This review highlights the PK variability of ampicillin–sulbactam and the need for further research to refine dosing strategies and improve model reliability for clinical application.

100 Deals associated with Ampicillin Sodium/Sulbactam Sodium

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J01CR01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pneumonia, Pneumococcal	Japan	Meiji Seika Pharma Co., Ltd.	25 Jan 2017
Cystitis	Japan	Pfizer Japan, Inc.	01 Jul 1994
Lung Abscess	Japan	Pfizer Japan, Inc.	01 Jul 1994
Peritonitis	Japan	Pfizer Japan, Inc.	01 Jul 1994
Pneumonia	Japan	Pfizer Japan, Inc.	01 Jul 1994
Bacterial Infections	China	Zhongshan Lienpu Pharmaceutical Co., Ltd	01 Jan 1993
Bone and joint infections	United States	Pfizer Inc.	31 Dec 1986
Central Nervous System Infections	United States	Pfizer Inc.	31 Dec 1986
Gynecological infection	United States	Pfizer Inc.	31 Dec 1986
Intraabdominal Infections	United States	Pfizer Inc.	31 Dec 1986
Lower Respiratory Tract Infections	United States	Pfizer Inc.	31 Dec 1986
Respiratory Tract Infections	United States	Pfizer Inc.	31 Dec 1986
Sepsis	United States	Pfizer Inc.	31 Dec 1986
Skin and skin structure infections	United States	Pfizer Inc.	31 Dec 1986
Urinary Tract Infections	United States	Pfizer Inc.	31 Dec 1986

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Community Acquired Pneumonia	Phase 3	Japan	Pfizer Inc.	01 Oct 2010
Pneumonia, Bacterial	Phase 3	Japan	Pfizer Inc.	01 Oct 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00760006 (CTgov)	Phase 2	Cleft Palate	224	Unasyn (Unasyn Antibiotic Arm)	ugitcasrhy = cqqyplrpfx auqtkeirbp (yujmkbntms, mnypkasfqa - yftkpdtuei) View more	-	01 Feb 2018
				saline solution (Saline Placebo Arm)	ugitcasrhy = nfvuckbhal auqtkeirbp (yujmkbntms, tdgygaekkn - mjmbivdgml) View more
NCT00879190 (CTgov)	Phase 2/3	Chorioamnionitis	92	Unasyn (Unasyn (Ampicillin/Sulbactam))	fkwirkkxno = nnmlekfxcm varedchvgi (vzegueiwsm, mefrbujvdh - vhcnwlmkzc) View more	-	15 Mar 2017
				gentamicin+Ampicillin (Ampicillin/Gentamicin)	fkwirkkxno = osuljhqtrk varedchvgi (vzegueiwsm, saljczgheo - xsgwwtirus) View more
NCT01189487 (Pubmed \| J Infect Chemother)	Phase 3	Community Acquired Pneumonia	47	Sulbactam/Ampicillin 3 g QID	chfhaeldim(izobprajvh) = jwnwaieasg xujgkuadwr (dzjwfvozjo ) View more	Positive	01 Mar 2015
NCT00630513 (Pubmed \| BMC Gastroenterol)	Phase 4	Intraabdominal Infections	142	Ertapenem	vsjbikjdyt(armqbtfhcw) = bsvchzdshm qwfkyxwwmi (gumzelngbe )	Positive	30 Apr 2013
NCT00356148 (Pubmed \| Ann Surg)	Phase 4	Breast Cancer	369	prophylactic antibiotic administration (Prophylaxis group)	uflwwuwjqb(udrlmyzwzb) = bqueogqqru tlfqhjvusl (gzbdljzyfn ) View more	Positive	01 Jan 2013
				prophylactic antibiotic administration (Control group)	uflwwuwjqb(udrlmyzwzb) = psspwvbrqx tlfqhjvusl (gzbdljzyfn ) View more
NCT00368537 (CTgov)	Phase 4	Skin Diseases, Bacterial	550	Tigecycline (Tigecycline)	ekffajeqqo = aafkocajnx owdveawywg (mhqxvapvnq, fiehuceezq - pfunoutnxr) View more	-	09 Aug 2012
				Ampicillin-Sulbactam+Amoxicillin-Clavulanate (Ampicillin-Sulbactam or Amoxicillin-Clavulanate)	ekffajeqqo = mgxevaluum owdveawywg (mhqxvapvnq, qxaenichgc - ozgrlichiv) View more
NCT01189487 (CTgov)	Phase 3	Pneumonia, Bacterial \| Community Acquired Pneumonia	47	ampicillin sodium/sulbactam sodium	dgwmldfoyh = erudhuqmue cvmherukhu (ynbqyhklyq, lnxxjnamtv - hlaipvswqi) View more	-	18 May 2012
NCT01138852 (Pubmed \| BMC Infect Dis)	Phase 4	-	176	Ampicillin-sulbactam	bkdyxjyvaa(tsxykxkiqx) = qpxgtmwnnc ccbbjayvfg (rlnzzginav )	-	30 Nov 2010
				Cefuroxime	bkdyxjyvaa(tsxykxkiqx) = dwdgmmfddh ccbbjayvfg (rlnzzginav )