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

+ [23]

Target

PBPs x β-lactamase

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

Active Organization

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (31 Dec 1986),

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

Regulation-

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Structure

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 Date01 Nov 2024

Sponsor / Collaborator-

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

NCT05867654 / Not yet recruitingPhase 4IIT

Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial

The goal of this clinical trial is compare the efficacy of oral and IV antibiotics in the treatment of orofacial osteomyelitis. The main question it aims to answer is: Are oral antibiotics as effective as IV antibiotics in the treatment of orofacial osteomyelitis.
Participants, once diagnosed with osteomyelitis, will be started on oral antibiotics for their treatment. Participants will follow up with oral and maxillofacial surgery clinic accordingly and their progression and compliance will be monitored.

Start Date31 Jul 2024

Sponsor / Collaborator

University of Louisville

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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424

Literatures (Medical) associated with Ampicillin Sodium/Sulbactam Sodium

22 Nov 2024·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.

01 Oct 2024·OTO open

Unmasking Nasal Septal Hematoma/Abscess: A Systematic Review and Meta‐analysis

Review

Author: Nanu, Douglas P. ; Adelsberg, Daniel ; Carr, Michele M. ; Nguyen, Shaun A. ; Radulovich, Nicholas P.

Abstract:

Objective:

We aim to discuss the demographics, symptoms, bacteriology, treatment, and sequelae associated with nasal septal hematoma/nasal septal abscess (NSH/NSA).

Data Sources:

CINAHL, PubMed, and Scopus were searched from inception until October 15, 2023.

Review Methods:

Preferred Reporting Items for Systematic Reviews and Meta‐analysis 2020 guidelines were followed. Inclusion criteria included patients who were diagnosed with a traumatic NSH/NSA. NSH/NSA due to surgical procedures was excluded. Demographics included N of patients, patient age, and gender. Symptoms, antibiotics given, bacteriology, and sequelae were analyzed. Meta‐analysis of continuous measures (mean, median), and proportions (%) with a 95% confidence interval (CI) was conducted.

Results:

Thirty studies (N = 598) were included. In total, 72.1% were males (95% CI: 67‐78). The total mean age was 21.6 years (range: 0.2‐85, 95% CI: 17.2‐26.1). The mean time from trauma to diagnosis was 8.2 days. Common symptoms at presentation included nasal obstruction/congestion at 60.3% (95% CI: 37.1‐81.4), nasal pain at 30.0% (17.2‐44.6), swelling at 20.4% (8.7‐35.5), headache at 15.5% (7.3‐26.0), and fever at 13.9% (7.3‐22.2). The most common pathogens isolated included Staphylococcus aureus at 56.5% (49.0‐63.8), Streptococcus species at 8.9% (5.2‐14.0), and Klebsiella pneumoniae at 6.3% (3.2‐10.8). Antibiotics given included amoxicillin‐clavulanate at 10.3% (4.5‐18.2), metronidazole at 9.5% (1.1‐24.9), ampicillin‐sulbactam at 8.9% (0.4‐26.5), and unspecified antibiotics at 39.7% (13.8‐69.2). The most common sequelae were nasal septal deformity/cartilage destruction at 14.3% (7.7‐22.6).

Conclusion:

NSA/NSH has an 8‐day delay in diagnosis from the time of trauma. First‐line practitioners should be made aware of the signs and symptoms of this condition to minimize the risk of morbidity.

03 Sep 2024·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Ampicillin-sulbactam against Acinetobacter baumannii infections: pharmacokinetic/pharmacodynamic appraisal of current susceptibility breakpoints and dosing recommendations

Article

Author: Abouelhassan, Yasmeen ; Abdelraouf, Kamilia ; Kuti, Joseph L ; Nicolau, David P

Abstract:

Background:

Sulbactam dosing for Acinetobacter baumannii infections has not been standardized due to limited available pharmacokinetics/pharmacodynamics (PK/PD) data. Herein, we report a comprehensive PK/PD analysis of ampicillin-sulbactam against A. baumannii pneumonia.

Methods:

Twenty-one A. baumannii clinical isolates were tested in the neutropenic murine pneumonia model. For dose-ranging studies, groups of mice were administered escalating doses of ampicillin-sulbactam. Changes in log10cfu/lungs relative to 0 h were assessed. Dose-fractionation studies were performed. Estimates of the percentage of of time during which the unbound plasma sulbactam concentrations exceeded the MIC (%fT > MIC) required for different efficacy endpoints were calculated. The probabilities of target attainment (PTA) for the 1-log kill plasma targets were estimated following clinically utilized sulbactam regimens.

Results:

Dose-fractionation studies demonstrated time-dependent kill. Isolates resistant to both sulbactam and meropenem required three times the exposures to achieve 1-log kill; median [IQR] %fT > MIC of 60.37% [51.6–66.8] compared with other phenotypes (21.17 [16.0–32.9] %fT > MIC). Sulbactam standard dose (1 g q6h, 0.5 h infusion) provided >90% PTA up to MIC of 4 mg/L. Sulbactam 3 g q8h, 4 h inf provided greater PTA for isolates with sulbactam-intermediate susceptibility (8 mg/L, 100% versus 86% following the standard dose). Despite the higher exposure following 3 g q8h, 4 h inf, PTA was ≤57% among sulbactam-resistant/meropenem-resistant isolates.

Conclusion:

Sulbactam standard dose is a valuable regimen across sulbactam-susceptible isolates while the high-dose extended-infusion provides additional benefit against sulbactam-intermediate isolates. Given that most of the sulbactam-resistant A. baumannii isolates are meropenem-resistant, high-dose prolonged-infusion regimens are not expected to be effective as monotherapy against infections due to these isolates.

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	JP	Pfizer Japan, Inc.	01 Jul 1994
Lung Abscess	JP	Pfizer Japan, Inc.	01 Jul 1994
Peritonitis	JP	Pfizer Japan, Inc.	01 Jul 1994
Pneumonia	JP	Pfizer Japan, Inc.	01 Jul 1994
Bacterial Infections	CN	Zhongshan Lienpu Pharmaceutical Co., Ltd	01 Jan 1993
Bone and joint infections	US	Pfizer Inc.	31 Dec 1986
Central Nervous System Infections	US	Pfizer Inc.	31 Dec 1986
Gynecological infection	US	Pfizer Inc.	31 Dec 1986
Intraabdominal Infections	US	Pfizer Inc.	31 Dec 1986
Lower Respiratory Tract Infections	US	Pfizer Inc.	31 Dec 1986
Respiratory Tract Infections	US	Pfizer Inc.	31 Dec 1986
Sepsis	US	Pfizer Inc.	31 Dec 1986
Skin and skin structure infections	US	Pfizer Inc.	31 Dec 1986
Urinary Tract Infections	US	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	JP	Pfizer Inc.	01 Oct 2010
Pneumonia, Bacterial	Phase 3	JP	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)	zivjsvdupw(inromrpcye) = rkfalsulko dlommyhhtw (ijhpeplvsu, yzcahmrzpm - yrfsegskxv) View more	-	01 Feb 2018
				saline solution (Saline Placebo Arm)	zivjsvdupw(inromrpcye) = gfnxgcruoa dlommyhhtw (ijhpeplvsu, zrcjfdzmrm - vgzhlrvjyz) View more
NCT00879190 (CTgov)	Phase 2/3	Chorioamnionitis	92	Unasyn (Unasyn (Ampicillin/Sulbactam))	vkndcyssda(hnrocykvzj) = qbwzgrvohc jekdbapifm (dwtbhipfnl, mbnmqbayek - zqhovdtiqm) View more	-	15 Mar 2017
				gentamicin+Ampicillin (Ampicillin/Gentamicin)	vkndcyssda(hnrocykvzj) = xrjeylyodx jekdbapifm (dwtbhipfnl, ntsqqqmyum - xicffvotwd) View more
ERS2015	Not Applicable	Community Acquired Pneumonia	-	Ampicillin-sulbactam + Macrolide	wzjsjvfhzp(iilshknlti) = igkbtxlnos wlikocrbif (dwzdolwqua ) View more	Positive	01 Sep 2015
				Fluoroquinolone	wzjsjvfhzp(iilshknlti) = utfzlwikpk wlikocrbif (dwzdolwqua ) View more
NCT01189487 (Pubmed \| J Infect Chemother)	Phase 3	Community Acquired Pneumonia	47	Sulbactam/Ampicillin 3 g QID	utwrwzcxcx(ykmvnstxtx) = iqvjntxdkp resetnwyma (zzapahsafd ) View more	Positive	01 Mar 2015
NCT00630513 (T.E.A. Study, Pubmed \| BMC Gastroenterol)	Phase 4	Intraabdominal Infections	142	Ertapenem	pohskbgyge(aneeaoweyw) = waalbyrxck vyvjrbdutv (iwmwezxntv )	Positive	30 Apr 2013
NCT00356148 (Pubmed \| Ann Surg)	Phase 4	Breast Cancer	369	prophylactic antibiotic administration (Prophylaxis group)	waiclbjyos(emoilgkgob) = omtivrxqjg veqlrsmywk (itqhtiooni ) View more	Positive	01 Jan 2013
				prophylactic antibiotic administration (Control group)	waiclbjyos(emoilgkgob) = nhkblftqoy veqlrsmywk (itqhtiooni ) View more
NCT00368537 (CTgov)	Phase 4	Skin Diseases, Bacterial \| Skin and skin structure infections \| Soft Tissue Infections	550	Tigecycline (Tigecycline)	ncmlhtnrsg(jugwcpbcyj) = fiejcjxmgz xpzcrglsrf (bfcxznwdxx, uuwafrfcdb - hohkvwdyav) View more	-	09 Aug 2012
				Ampicillin-Sulbactam+Amoxicillin-Clavulanate (Ampicillin-Sulbactam or Amoxicillin-Clavulanate)	ncmlhtnrsg(jugwcpbcyj) = njidhgjlvd xpzcrglsrf (bfcxznwdxx, cgrfpvekfv - lbyxdtouxk) View more
NCT01189487 (CTgov)	Phase 3	Pneumonia, Bacterial \| Community Acquired Pneumonia	47	ampicillin sodium/sulbactam sodium	tkjvkvnzxc(rsmnuaxayg) = ohtibuyfvn yqsqfqkrns (sgcxintslp, ljyhstqmil - mouvrxopux) View more	-	18 May 2012
SEPsIS HL080926 (ASN2011)	Not Applicable	Acute Kidney Injury \| Sepsis IL-6 \| neutrophil gelatinase-associated lipocalin (NGAL)	-	Bactericidal antibiotics (ampicillin/sulbactam)	ixigwaweeq(jjwjnanfvb) = buzckhdgjv xysdppgtdd (bnsmuoushj )	Negative	08 Nov 2011
				Placebo (saline)	vvzowcwifd(yzszzatdsn) = gtegmlnrhn zrjvjavqvg (vnxrpzzust ) View more
ASN2011	Not Applicable	Acute Kidney Injury	12	Ampicillin/Sulbactam 2g/1g	gkofjumcjw(rpvgmnguqn) = tcddmsjfui nyhufqkaih (jqlxjkupuu, 7.7)	Positive	08 Nov 2011