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

CystitisLung AbscessPeritonitis+ [11]

Inactive Indication

Community Acquired PneumoniaPneumonia, Bacterial

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.

Chemix, Inc.

Sawai Pharmaceutical Co., Ltd.

+ [5]

Inactive 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

NCT06494072

/ RecruitingPhase 4IIT

Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.

The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia.
The main questions it aims to answer are:
* Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?
* Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?
Participants will
* be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
* receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics
Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.

Start Date22 Aug 2024

Sponsor / Collaborator

Medical College of Wisconsin

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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473

Literatures (Medical) associated with Ampicillin Sodium/Sulbactam Sodium

01 Apr 2025·JAVMA-JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION

Prophylactic antibiotic use is common in dogs and cats presenting for procedures at veterinary referral dental practices

Article

Author: Bollig, Emma R. ; Granick, Jennifer L. ; Goldschmidt, Stephanie L. ; Montebello, Jennifer A. ; Volk, Allison C.

Abstract:

OBJECTIVE:

Antimicrobial stewardship is critical for the prevention of antimicrobial resistance. A lack of prescribing guidelines makes overprescribing in veterinary dentistry likely and represents an opportunity for improvement of stewardship practices. This study described prescribing practices of residency-trained and board-certified veterinary dentists for dogs and cats undergoing dental procedures.

METHODS:

Antibiotic-use data were collected from the first 10 patients presenting for a dental procedure at each of 22 participating clinics beginning on October 2, 2023.

RESULTS:

35% of patients undergoing procedures received 1 or more systemically administered antibiotic, most commonly amoxicillin–clavulanic acid, ampicillin-sulbactam, and clindamycin. Half (43 of 85 [50.6%]) of prescriptions for dogs were for perioperative or postoperative prophylaxis. For dogs, antibiotic duration for prophylactic versus treatment purposes was not significantly different. Common conditions included periodontal disease, tooth fractures, and oral masses. Comorbid conditions were present in 22.3% (49 of 220) of patients. Presence of comorbid conditions was not a risk factor for antibiotic prescribing. Tooth extractions were a risk factor for antibiotic prescribing among patients with periodontal disease, and those with ≥ 11 were more likely to receive antibiotics than those with < 5 extractions.

CONCLUSIONS:

This study characterized antibiotic use among canine and feline dental procedures performed by residency-trained and board-certified veterinary dentists and identified tooth extractions as a risk factor for antibiotic prescribing.

CLINICAL RELEVANCE:

The results obtained from this study provide insight into prescribing practices in a referral setting and impetus to develop outcomes-based studies to determine the need for prophylactic antibiotics during specific procedures, especially tooth extractions.

06 Feb 2025·Journal of the Pediatric Infectious Diseases Society

Suggested Dosing of Select Beta-lactam Agents for the Treatment of Antimicrobial-Resistant Gram-Negative Infections in Children

Review

Author: Girotto, Jennifer E ; Iacono, Denise ; Dassner, Aimee M ; Stimes, Grant ; Morrisette, Taylor ; Chiotos, Kathleen ; Tamma, Pranita D ; Gainey, Andrew B ; Hsu, Alice J ; Tran, M Tuan ; Lockowitz, Christine R ; Wilson, William S ; Bio, Laura L

Abstract:

The Infectious Diseases Society of America (IDSA) publishes annual guidance on the treatment of antimicrobial-resistant (AMR) gram-negative infections. Within the AMR guidance, suggested dosages of antibiotics for adults infected with AMR pathogens are provided. This document serves as a companion document to the IDSA guidance to assist pediatric specialists with dosing β-lactam agents for the treatment of AMR infections in children. A panel of 13 pediatric infectious diseases specialists, including 11 pharmacists and 2 physicians, reviewed existing pharmacokinetic/pharmacodynamic, animal, and clinical data for newer β-lactam agents that are available in the United States and suggested for the treatment of AMR infections (ie, cefiderocol, ceftazidime-avibactam, ceftazidime-avibactam and aztreonam, ceftolozane-tazobactam, imipenem-cilastatin-relebactam, meropenem-vaborbactam, sulbactam-durlobactam). Suggested dosing for ampicillin-sulbactam is also provided, given complexities in dosing for carbapenem-resistant Acinetobacter baumannii infections. Consensus-based suggested dosing for β-lactam agents used to treat AMR infections in neonates, infants, children, and adolescents and relevant supporting evidence are provided. Content is up to date as of December 1, 2024. Gaps and limitations to existing data are discussed. Optimizing antibiotic dosing is critical to improving the outcomes of children with AMR infections.

01 Jan 2025·International Wound Journal

RETRACTION: Effect of Clindamycin Compared with Ampicillin‐Sulbactam as Prophylactic Antibiotics for Wound Infections Following Major Surgery for Head and Neck Cancer: A Meta‐Analysis

RETRACTION: Y.Hu, A.Yan, and F.Jiang, “,” International Wound Journal20, no. (2023): 4151–4158, https://doi-org.libproxy1.nus.edu.sg/10.1111/iwj.14312.The above article, published online on 22 July 2023, in Wiley Online Library (http://onlinelibrary.wiley.com.libproxy1.nus.edu.sg/), has been retracted by agreement between the journal Editor in Chief, Professor Keith Harding; and John Wiley & Sons Ltd. Following an investigation by the publisher, all parties have concluded that this article was accepted solely on the basis of a compromised peer review process. The editors have therefore decided to retract the article. The authors disagree with the retraction.

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
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)	hnmhrmlaqk = psbptwbwwe jzefxabcfi (mhuuwwagyp, kvzmlrwvbq - lidpibfapc) View more	-	01 Feb 2018
				saline solution (Saline Placebo Arm)	hnmhrmlaqk = primfjlmxd jzefxabcfi (mhuuwwagyp, ahkhvoyxju - eomfginrwc) View more
NCT00879190 (CTgov)	Phase 2/3	Chorioamnionitis	92	Unasyn (Unasyn (Ampicillin/Sulbactam))	ctzbbrluwj = jcgiuohhic xabvftnkbz (zrutjckcnl, rlmlkjbdgr - ckohlrhhkm) View more	-	15 Mar 2017
				gentamicin+Ampicillin (Ampicillin/Gentamicin)	ctzbbrluwj = wnutqgoyyx xabvftnkbz (zrutjckcnl, eqzylmkrjr - ycyjrrjnrs) View more
ERS2015	Not Applicable	Community Acquired Pneumonia	-	Ampicillin-sulbactam + Macrolide	sgijtwolyh(hvgnocglpz) = imnfqjmjfa xkwrrrnesz (lcuzciwemo ) View more	Positive	01 Sep 2015
				Fluoroquinolone	sgijtwolyh(hvgnocglpz) = bxbcitwzlu xkwrrrnesz (lcuzciwemo ) View more
NCT01189487 (Pubmed \| J Infect Chemother)	Phase 3	Community Acquired Pneumonia	47	Sulbactam/Ampicillin 3 g QID	yasnbmnjes(nuseyuadou) = hvitnpbvtn wcjpgprrlg (ypqdscdhsk ) View more	Positive	01 Mar 2015
NCT00630513 (T.E.A. Study, Pubmed \| BMC Gastroenterol)	Phase 4	Intraabdominal Infections	142	Ertapenem	eouyaqcene(xtdmenjqxv) = fykarpysqt ntkorfllaj (dqjjkljozt )	Positive	30 Apr 2013
NCT00356148 (Pubmed \| Ann Surg)	Phase 4	Breast Cancer	369	prophylactic antibiotic administration (Prophylaxis group)	qgkuaxzbol(svfufbezvx) = otwxgjtdgi efawxwamrp (cysgirprpq ) View more	Positive	01 Jan 2013
				prophylactic antibiotic administration (Control group)	qgkuaxzbol(svfufbezvx) = iatryrrzvv efawxwamrp (cysgirprpq ) View more
NCT00368537 (CTgov)	Phase 4	Skin Diseases, Bacterial \| Skin and skin structure infections \| Soft Tissue Infections	550	Tigecycline (Tigecycline)	ecivrasyez = nnwtqgmwfe bkrsetkcmn (irxjrsepef, lyqgyfuhtt - vyojdrdlso) View more	-	09 Aug 2012
				Ampicillin-Sulbactam+Amoxicillin-Clavulanate (Ampicillin-Sulbactam or Amoxicillin-Clavulanate)	ecivrasyez = cjkcpqceov bkrsetkcmn (irxjrsepef, cgtqfantrl - ytfxqrfcns) View more
NCT01189487 (CTgov)	Phase 3	Pneumonia, Bacterial \| Community Acquired Pneumonia	47	ampicillin sodium/sulbactam sodium	jtwvlxzlxt = xibhpusdrd qpunxfrykf (jnnrkoctzf, faaxlmbaho - ppqrzpcppn) View more	-	18 May 2012
ASN2011	Not Applicable	Acute Kidney Injury	12	Ampicillin/Sulbactam 2g/1g	qzalbhfaoj(ndbgaclbya) = xlsdipsyft ttqoguazsc (tkspaxqdnt, 7.7)	Positive	08 Nov 2011
SEPsIS HL080926 (ASN2011)	Not Applicable	Acute Kidney Injury \| Sepsis IL-6 \| neutrophil gelatinase-associated lipocalin (NGAL)	-	Bactericidal antibiotics (ampicillin/sulbactam)	feptjfxvlm(ctlpkvrhyk) = fukbdvqydx qlyrewuirl (aropllfjzr )	Negative	08 Nov 2011
				Placebo (saline)	vnunvnqntn(dzldhxsetg) = kbwfpicbgo dxtaxshydz (nulhjwussz ) View more