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+ [10]

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+ [5]

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-

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

NCT06494072 / Not yet 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 Date01 Jul 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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431

Literatures (Medical) associated with Ampicillin Sodium/Sulbactam Sodium

01 Oct 2024·OTO Open

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

Review

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

AbstractObjectiveWe aim to discuss the demographics, symptoms, bacteriology, treatment, and sequelae associated with nasal septal hematoma/nasal septal abscess (NSH/NSA).Data SourcesCINAHL, PubMed, and Scopus were searched from inception until October 15, 2023.Review MethodsPreferred 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.ResultsThirty 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).ConclusionNSA/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 ; Kuti, Joseph L ; Abdelraouf, Kamilia ; Nicolau, David P

AbstractBackgroundSulbactam 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.MethodsTwenty-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.ResultsDose-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.ConclusionSulbactam 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.

01 Sep 2024·Surgical Infections

Ampicillin–Sulbactam for Carbapenem-Susceptible Acinetobacter baumannii Pneumonia: A Case for High-Dose, Continuous Infusion Dosing Strategy in the Trauma ICU

Article

Author: Shoulders, Bethany R. ; Santevecchi, Barbara A. ; Venugopalan, Veena ; Alexander, Kaitlin M.

Background: The optimal ampicillin-sulbactam dosing regimen for carbapenem-susceptible Acinetobacter baumannii isolates in critically ill trauma patients has not been clearly defined. One strategy to provide the adequate sulbactam dose includes high-dose continuous infusion. Case(s) Description: We present three cases of critically ill trauma patients with augmented renal clearance treated with high-dose ampicillin-sulbactam through an intravenous continuous infusion for ventilator-associated pneumonia. All A. baumannii isolates were susceptible to sulbactam with low minimum inhibitory concentrations. All achieved clinical cure at the end of therapy and no recurrent pneumonia was noted. No clinically substantial adverse effect attributable to ampicillin-sulbactam therapy occurred. Discussion: There is limited evidence to endorse high-dose, continuous infusion ampicillin-sulbactam for treatment of infections caused by carbapenem-susceptible A. baumannii. This report presents three critically ill trauma patients with augmented renal clearance that achieved positive clinical outcomes with higher doses of ampicillin-sulbactam administered through a continuous infusion.

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
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
Pneumonia, Bacterial	Preclinical	JP	Pfizer Inc.	01 Oct 2010
Community Acquired Pneumonia	Discovery	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)	gcinosliql(fkzfnfbvml) = aignggdwpn vhevuzdfke (ddhlyikkbs, rrqtuceyot - eiubmtxunz) View more	-	01 Feb 2018
				saline solution (Saline Placebo Arm)	gcinosliql(fkzfnfbvml) = zlxbicwmxd vhevuzdfke (ddhlyikkbs, qsvzryvfwm - znpqqwghcm) View more
NCT00879190 (CTgov)	Phase 2/3	Chorioamnionitis	92	Unasyn (Unasyn (Ampicillin/Sulbactam))	jxzsrydpfw(latlagfpoh) = xeehfjvhqi jqixegvsij (vsekkzjlvi, movqukrfid - humiynmxqo) View more	-	15 Mar 2017
				gentamicin+Ampicillin (Ampicillin/Gentamicin)	jxzsrydpfw(latlagfpoh) = glxisgaunc jqixegvsij (vsekkzjlvi, qcaxekyltv - ixsktwrhtx) View more
ERS2015	Not Applicable	Community Acquired Pneumonia	-	Ampicillin-sulbactam + Macrolide	(fmqgqddztq) = auqlyhfuaj qxjvxspqzx (nprnmkdtwv ) View more	Positive	01 Sep 2015
				Fluoroquinolone	(fmqgqddztq) = auvewvduhw qxjvxspqzx (nprnmkdtwv ) View more
NCT01189487 (Pubmed \| J Infect Chemother)	Phase 3	Community Acquired Pneumonia	47	Sulbactam/Ampicillin 3 g QID	bekigrshqf(aagqqybdim) = moexkfvdxn vsvavemkuo (ggznjttsbe ) View more	Positive	01 Mar 2015
NCT00356148 (Pubmed \| Ann Surg)	Phase 4	Breast Cancer	369	prophylactic antibiotic administration (Prophylaxis group)	djpitygglq(wswgwempsx) = ruybhtzykl ssenchxcnh (qsvbwevnuf ) View more	Positive	01 Jan 2013
				prophylactic antibiotic administration (Control group)	djpitygglq(wswgwempsx) = uxczsanbfw ssenchxcnh (qsvbwevnuf ) View more
NCT00368537 (CTgov)	Phase 4	Skin Diseases, Bacterial \| Skin and skin structure infections \| Soft Tissue Infections	550	Tigecycline (Tigecycline)	qobtxwewau(nugfqzoswh) = rvyzjkqrju nnmbhunqba (axnsharbjj, fkpidvssdw - vrbfgoopcf) View more	-	09 Aug 2012
				Ampicillin-Sulbactam+Amoxicillin-Clavulanate (Ampicillin-Sulbactam or Amoxicillin-Clavulanate)	qobtxwewau(nugfqzoswh) = umgknaulnd nnmbhunqba (axnsharbjj, ustyszpigr - fqvpwnyqic) View more
NCT01189487 (CTgov)	Phase 3	Pneumonia, Bacterial \| Community Acquired Pneumonia	47	ampicillin sodium/sulbactam sodium	ihnpeayrvs(dmktndrgxq) = trvgsssckb wfznybpgzz (ydgxczejla, qhuofivufo - chdxokbspm) View more	-	18 May 2012
ASN2011	Not Applicable	Acute Kidney Injury	12	Ampicillin/Sulbactam 2g/1g	dxnterazlu(cpreslbjuc) = hvdqkdnrhf tgkdcqskem (jemeqhtunh, 7.7)	Positive	08 Nov 2011
NCT01138852 (Pubmed \| BMC Infect Dis)	Phase 4	-	176	Ampicillin-sulbactam	livkwlvnpo(rjiiutmpjn) = ihnpkmvnkn ojliedxnru (dzawjspmgy )	-	30 Nov 2010
				Cefuroxime	livkwlvnpo(rjiiutmpjn) = hikqtmjnek ojliedxnru (dzawjspmgy )