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 Inc.

Meiji Seika Pharma Co., Ltd.

Chemix, 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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416

Literatures (Medical) associated with Ampicillin Sodium/Sulbactam Sodium

01 Dec 2025·Journal of Infection and Public Health

Antimicrobial resistance pattern of enterococcus species among clinical isolates in Iran: A systematic review and meta-analysis

Review

Author: Akhgarzad, Ali ; Ahmadian, Maryam ; Nikoohemmat, Mohammad ; Alavi Darazam, Ilad ; Jabbari, Farzaneh ; Javandoust Gharehbagh, Farid ; Ebrahimi, Navid

Enterococcus faecalis (E. faecalis) and Enterococcus faecium (E. faecium) are leading pathogens responsible for both community-acquired and nosocomial infections, with escalating antibiotic resistance reported worldwide. This meta-analysis evaluated resistance patterns in Iran by reviewing 46 studies published between 2017 and 2023, retrieved from PubMed, Scopus, and national Iranian databases (SID, Magiran, Scimed). Among 2379 E. faecalis and 1219 E. faecium isolates, resistance was markedly higher in E. faecium. The highest resistance rate in E. faecalis was observed against trimethoprim/sulfamethoxazole (82.0 %), whereas E. faecium demonstrated the highest resistance to ampicillin-sulbactam (91.7 %). Vancomycin-resistant Enterococci (VRE) prevalence was notably elevated (E. faecium: 52.3 %; E. faecalis: 15.8 %). Linezolid remained the most effective agent, with low resistance rates reported for E. faecalis (1.6 %) and E. faecium (3.1 %). These findings highlight a critical level of antimicrobial resistance in clinical Enterococcus isolates in Iran, underscoring the urgent need for strengthened infection control measures and comprehensive antibiotic stewardship policies.

01 Dec 2025·VETERINARY JOURNAL

Population pharmacokinetics of intravenous ampicillin in awake and anesthetised dogs

Article

Author: Kohlhauer, Matthias ; Pressiat, Claire ; Hulin, Anne ; Marotto, Stéphanie ; Verwaerde, Patrick ; Maurey, Christelle ; Audrac, Claire

The aim of this study is to describe a population pharmacokinetic model for intravenous ampicillin-sulbactam in awake and anaesthetized dogs in these two treatment scenarios and to compute PK/PD cut-offs (PK/PD_CO). This was a prospective clinical trial in 20 client-owned dogs, either treated by ampicillin after post-surgical infection, or in the context of surgical antimicrobial prophylaxis. All animals received 20 mg/kg of ampicillin by slow iv route. During anesthesia ampicillin administration was repeated every 90 min according to standard recommendations, whereas in awake animals, ampicillin administration was every 8 h. A bi-compartmental model best described the data. Anesthesia and creatinine plasma concentration at the administration correlated with ampicillin clearance, which was 318 ± 36 ml/kg/h in awake animals and 186 ± 12 ml/kg/h in anesthetized animals. Monte-Carlo simulation showed that 20 mg/kg every 8 h in awake dogs led to PK/PD_CO of 0.5 mg/L using a target of 40 %fT>MIC and 0.25 mg/L with 50 % fT>MIC. Administration of ampicillin by prolonged infusion (4 h) every 8 h allowed to achieve a PK/PD_CO of 4 mg/L and 2 mg/L with the 40 % and 50 % targets, respectively. In anesthetized animals, repetition of the 20 mg/kg of ampicillin every 90 min allowed to remain above 4 mg/L during 100 % of the time. Plasma clearance of ampicillin inversely correlates with creatinine plasma concentration in client-owned dogs and is reduced of about 40 % during anesthesia. In awake dogs, the standard regimen of 20 mg/kg every 8 h by intravenous route is probably insufficient to treat soft tissues infections caused by gram-negative bacteria. Using prolonged infusion could help to increase ampicillin efficacy against specific pathogens.

01 Nov 2025·Ear, nose, & throat journal

Cervical Cutaneous Emphysema after Laser Microsurgery for Treatment of Laryngeal Cancer: Case Report

Article

Author: Santivañez, Juan Jose ; Granados, Nicolas ; Hakim Tawil, Jose Antonio

Laser laryngectomy is a minimally invasive surgical technique that offers advantages such as precise and limited resections, magnification of the surgical field by microscopy, and improved patient outcomes. However, it is not without risks, and intraoperative complications have been reported, including cervical-cutaneous emphysema. This case report presents a rare complication of cervical-cutaneous emphysema after laser laryngectomy occurring in a 57-year-old patient with glottic carcinoma. The patient underwent laser cordectomy, and after an uneventful procedure, the patient experienced an intense coughing episode followed by swelling and progressive emphysema. The patient was kept under surveillance in the intensive care unit and received ampicillin sulbactam, protective orotracheal intubation, and voice rest. The patient had a good clinical evolution, and the emphysema resolved within 8–10 days. This case highlights the importance of prompt recognition and management of complications that can arise from laser laryngectomy. Although this technique offers several advantages, it is not risk-free, and intraoperative complications can occur. As such, careful consideration and patient selection are important to minimize the risks and achieve successful outcomes.

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)	lbyrwjcxfi = qgxsupxcug xbzcdrzwwm (mmiuighawn, atdekqcrhe - eziaesyycx) View more	-	01 Feb 2018
				saline solution (Saline Placebo Arm)	lbyrwjcxfi = xfaahdfsue xbzcdrzwwm (mmiuighawn, ykbuxxxilv - sikbnlbhzu) View more
NCT00879190 (CTgov)	Phase 2/3	Chorioamnionitis	92	Unasyn (Unasyn (Ampicillin/Sulbactam))	rbazxkbbqj = siexnucpak wessemvpga (fmomufwzfo, lpronjiagx - nrcyocfbnt) View more	-	15 Mar 2017
				gentamicin+Ampicillin (Ampicillin/Gentamicin)	rbazxkbbqj = xtyfghjosj wessemvpga (fmomufwzfo, sukiftbkhj - kwpxurwlad) View more
NCT01189487 (Pubmed \| J Infect Chemother)	Phase 3	Community Acquired Pneumonia	47	Sulbactam/Ampicillin 3 g QID	skrgdhdbos(usjumnubmj) = plswcgxbxh qybquyhjte (xvglmjfqxv ) View more	Positive	01 Mar 2015
NCT00630513 (T.E.A. Study, Pubmed \| BMC Gastroenterol)	Phase 4	Intraabdominal Infections	142	Ertapenem	cnrmnthlkf(mgkimwanwt) = absjuhdiiz euphmtrdei (xjfwnmthkd )	Positive	30 Apr 2013
NCT00356148 (Pubmed \| Ann Surg)	Phase 4	Breast Cancer	369	prophylactic antibiotic administration (Prophylaxis group)	yigaikjnaz(eurlahvubi) = wnibgeackt wbegwagigt (qsfwdianqv ) View more	Positive	01 Jan 2013
				prophylactic antibiotic administration (Control group)	yigaikjnaz(eurlahvubi) = qkdrwtkihy wbegwagigt (qsfwdianqv ) View more
NCT00368537 (CTgov)	Phase 4	Skin Diseases, Bacterial	550	Tigecycline (Tigecycline)	folzumtnhp = luvwdpcmcv rmddxmgghp (ssnvqxrkuw, kabwygpmvv - zutvnyrkuc) View more	-	09 Aug 2012
				Ampicillin-Sulbactam+Amoxicillin-Clavulanate (Ampicillin-Sulbactam or Amoxicillin-Clavulanate)	folzumtnhp = bpabfgvsyi rmddxmgghp (ssnvqxrkuw, vdyjdpjoeq - vgkzyhihqr) View more
NCT01189487 (CTgov)	Phase 3	Pneumonia, Bacterial \| Community Acquired Pneumonia	47	ampicillin sodium/sulbactam sodium	waabcthtbe = fwbbodbncy fgdlbbyoar (cflrfsonlr, qjezwkzwqg - zqsoukedwj) View more	-	18 May 2012
NCT01138852 (Pubmed \| BMC Infect Dis)	Phase 4	-	176	Ampicillin-sulbactam	zqavwgtkno(bpyodrwgzu) = iphecajhrn lzjtmfeoio (mihyvhtbcd )	-	30 Nov 2010
				Cefuroxime	zqavwgtkno(bpyodrwgzu) = qcvptsiwlw lzjtmfeoio (mihyvhtbcd )