A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are:
* How well does Arm D treat mycobacterium abscessus pulmonary disease?
* What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects.
Participants will:
* Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930)
* Be given Arm D for 4 weeks or standard of care treatments for 6 weeks.
* Be reviewed by the study doctors weekly for checkups and tests.
* Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.

Start Date01 Apr 2027

Sponsor / Collaborator

The University of Queensland

[+1]

NCT07228702

/ Enrolling by invitationPhase 1IIT

Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection: An Open Label Individual Patient Study

This study aims to use mycobacteriophage therapy, using identified in-vitro effective Mycobacteriophage Muddy_HRMN0052, along with combination conventional antimycobacterial therapy for their NTM pulmonary disease with Mycobacterium abscessus with goal to reduce infection burden and improve pulmonary disease

Start Date11 Jan 2026

Sponsor / Collaborator

Vancouver Coastal Health

CTIS2024-516232-10-00

/ Not yet recruitingPhase 4IIT

Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.

Start Date01 Dec 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nimes

100 Clinical Results associated with Cilastatin Sodium/Imipenem

100 Translational Medicine associated with Cilastatin Sodium/Imipenem

100 Patents (Medical) associated with Cilastatin Sodium/Imipenem

4,370

Literatures (Medical) associated with Cilastatin Sodium/Imipenem

31 Dec 2026·Human Vaccines & Immunotherapeutics

Serotype distribution of Streptococcus pneumoniae in children with invasive diseases in Türkiye, 2019–2025: An update in the 10th to 15th years of routine pneumococcal conjugate vaccination

Article

Author: Karadağ Öncel, Eda ; Ay Altıntop, Yasemin ; Akgün Karapınar, Deniz Bahar ; Öz, Fatma Nur ; Hasçelik, Gülşen ; Aydemir, Sabire Şöhret ; Güdücüoğlu, Hüseyin ; Hazırolan, Gülşen ; Duman, Yücel ; Koyuncu Özyurt, Özlem ; Öztürk, Candan ; Özhak Baysan, Betil ; Yılmaz, Nisel ; Emiroğlu, Melike ; Uslu, Hakan ; Özakın, Cüneyt ; Hasdemir, Ufuk ; Öcal, Duygu ; Çizmeci, Zeynep ; Öksüz, Lütfiye ; Devrim, İlker ; Yaman, Akgün ; Özbek, Özgen Alpay ; Karbuz, Adem ; Aydın, Faruk ; Birinci, Asuman ; Zer, Yasemin ; Dinleyici, Ener Çağrı ; Akpolat, Nezahat ; Sorguç, Yelda ; Özkaya, Esra ; Ceyhan, Mehmet ; Kara, Soner Sertan

Invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae remains a significant cause of pediatric morbidity. This study updates the serotype distribution and antibiotic resistance of pediatric IPD in Türkiye for 2019-2025, about a decade after 13-valent pneumococcal conjugate vaccine (PCV13) was introduced in the National Immunization Program. We conducted a multicenter, hospital-based prospective surveillance between January 2019-April 2025 in children <18 y across 28 tertiary hospitals. S. pneumoniae isolates from sterile sites (blood, cerebrospinal fluid, pleural fluid) were confirmed by standard methods and serotyped using the Quellung reaction. Antimicrobial susceptibility was determined by gradient test as per CLSI criteria. A total of 203 samples were identified from 203 pediatric cases (median age 4 y, 56.2% boys). The clinical presentations were bacteremia/sepsis (57.6%) and meningitis (26.1%). The leading serotypes were 3 (14.3%), 14 (10.3%), 19F (7.9%), 19A (6.4%), 9N (4.4%), 15A (4.4%). PCV13 serotypes accounted for 46.8% isolates, while PCV7 and PCV10 serotypes were detected in 23.2% and 24.6%, respectively. Broader vaccines would increase coverage: PCV15 (46.8%) and PCV20 (56.7%). Antibiotic susceptibility (non-meningitis breakpoint) remained high for beta-lactams; 91.9% of isolates were penicillin-susceptible, with only 0.7% fully resistant, and cefotaxime resistance was rare (2.7%). Conversely, macrolide resistance was high, with 60.2% of isolates resistant to erythromycin. A decade after PCV13 implementation, vaccine serotypes - particularly 3, 14, 19F, and 19A - still cause nearly half of pediatric IPD, though non-vaccine serotypes such as 9N and 15A are rising. Higher-valent PCVs may improve protection, and continued surveillance is critical to guide vaccine policy and treatment strategies.

01 Oct 2026·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Appropriateness of antibiotic use in the emergency department: A five-year retrospective study in a region with high antibiotic consumption

Article

Author: Özgürel, Tolga ; Keske, Şiran ; Ergönül, Önder ; Bakır, Emine ; Kaçmaz, Bahar

BACKGROUND:

We aimed to evaluate the use of antibiotics for upper respiratory tract infections (URTIs), particularly during the COVID-19 pandemic in an emergency department (ED), by assessing adherence to the clinical pathway implemented seven years ago.

METHODS:

We performed a retrospective study from 2018 to 2022 and included patients with URTIs only in April and November of each year to control for temporal bias.

RESULTS:

A total of 1,683 patients with URTIs were included. We found that 242 of 1,683 (14.3%) patients were administered or prescribed antibiotics in the ED, and 214 of 1,683 (12.7%) had clinical pathway non-adherence. Of the 242 patients, 136 (56.2%) were female, and the mean age was 37.8 (SD: 0.94). The most frequent diagnoses were acute tonsillopharyngitis (55%) and cold/non-specific URTIs (38.4%), respectively. The Streptococcus pyogenes rapid antigen test was positive in 23 of 133 (17.2%) patients with acute tonsillopharyngitis, and 4 of 133 patients had a 4-point Centor score. The first choice of antibiotics was beta-lactams. In multivariate analysis, the predictors of appropriate antibiotic use among patients were acute tonsillopharyngitis (OR: 17.8, CI 3.96-80.1, p < 0.001) and rapid S. pyogenes antigen positivity (OR: 11.7, CI 3.9-23.7, p < 0.001).

CONCLUSIONS:

Despite the global inappropriate use of antibiotics during the COVID-19 pandemic, our study observed a decline in non-adherence to clinical pathways and antibiotic use in URTIs from 2020 to 2022, likely due to increased awareness among ED physicians and the impact of educational programs. Long-term success will require ongoing training, feedback, and updates for ED physicians.

01 Jul 2026·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

A multicenter, randomized, double-blind, imipenem/cilastatin-controlled clinical study of cefiderocol for the treatment of complicated urinary tract infections caused by gram-negative pathogens in chinese adults

Article

Author: Huang, Haihui ; Jia, Bei ; Baba, Takamichi ; Zhang, Yingyuan ; Gu, Tao ; Sonoyama, Takuhiro ; Fan, Deyong ; Xie, Ningning ; Wu, Henglan ; Yuan, Jinyi ; Dou, Honghong

BACKGROUND:

Cefiderocol, a siderophore cephalosporin, is approved for the treatment of complicated urinary tract infections (cUTIs) and other indications in the USA, Europe, and Japan. However, clinical data from China are lacking.

METHODS:

This multicenter, randomized, double-blind, active-controlled bridging study was conducted in China closely mirroring the global APEKS-cUTI study. Adult patients (aged ≥18 years) with cUTI (with or without pyelonephritis) and ≥2 clinical symptoms were randomized 2:1 to receive either cefiderocol (2 g) or imipenem-cilastatin sodium (IPM/CS; 1 g) every 8 hours for 5-14 days. The primary endpoint was the composite response rate at the test-of-cure (TOC) visit within the microbiological intention-to-treat (micro-ITT) population. The point estimate of the difference >-15% in the primary endpoint between the two groups demonstrates the consistency with the efficacy results of the APEKS-cUTI study.

RESULTS:

Of 150 patients (cefiderocol, 100; IPM/CS, 50), 67 and 34 patients were in the micro-ITT population, respectively. At TOC, 62.7% (42/67) and 26.5% (9/34) of patients in the cefiderocol and IPM/CS groups achieved the composite response, respectively, (difference: 35.93% [95% CI, 17.92%-53.93%]). Treatment-emergent adverse events (TEAEs) occurred in 74.0% (74/100) and 80.0% (40/50) in the cefiderocol and IPM/CS groups, with drug-related TEAEs occurring in 27.0% (27/100) and 40.0% (20/50) of patients, respectively. TEAEs were mostly mild. However, four patients in the cefiderocol group discontinued due to TEAEs.

CONCLUSION:

Cefiderocol demonstrated efficacy, which was non-inferior to imipenem, and safety in Chinese adult cUTI patients supporting its approval in China, consistent with findings from the APEKS-cUTI study.

TRIAL NUMBER:

ChiCTR2400090538.

News (Medical) associated with Cilastatin Sodium/Imipenem

06 Jul 2026

·www.prnewswire.com

Nexsphere-F™ Clinical Study Published in Radiology, Showing 57% Reduction in Knee Osteoarthritis Pain

SEOUL, South Korea, July 6, 2026 /PRNewswire/ -- NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, announced today that Radiology, the leading peer-reviewed journal in radiology and medical imaging with an impact factor of 17.6, has published clinical results for Nexsphere-F™, the Company's fast-resorbable microsphere for embolization. The study, titled "Genicular Artery Embolization Using Rapidly Resorbable Gelatin-based Microspheres for Osteoarthritis-related Knee Pain," was conducted by researchers at Charité – Universitätsmedizin Berlin, ranked eighth on Newsweek's World's Best Hospitals 2026 list. The Company believes this is the largest prospective, single-center observational study to date evaluating genicular artery embolization (GAE) using a resorbable embolic agent. The prospective study enrolled 194 patients with knee osteoarthritis who had not responded to conventional conservative treatments, including corticosteroid and hyaluronic acid injections, and evaluated the safety and clinical outcomes of GAE performed with Nexsphere-F™. Prospective studies, which follow patients according to a predetermined protocol, are widely regarded as providing a higher level of clinical evidence than retrospective analyses. Across 239 procedures, GAE using Nexsphere-F™ achieved a 100% technical success rate. Patients' pain scores, measured on the Numeric Rating Scale, decreased from a median of 7 before the procedure to 3 at 12 months post-procedure, a 57% reduction. Knee function and quality of life, assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), improved significantly across all measures, with approximately 80% of patients achieving a minimum clinically important difference (MCID). No moderate or severe procedure-related adverse events were reported. NEXTBIOMEDICAL expects the results to support its expansion into the European market, where Nexsphere-F™ holds CE marking under the Medical Device Directive (CE-MDD). The clinical data is also expected to serve as key evidence for future efforts to expand insurance reimbursement and adoption among medical institutions. In the United States, the RESORB clinical trial to support FDA approval is currently underway and progressing smoothly. The study's authors described Nexsphere-F™ as a novel embolic agent that offers a favorable balance of safety and efficacy relative to permanent microspheres and imipenem-cilastatin (IPM-CS). Permanent microspheres and IPM-CS have been associated with skin discoloration rates as high as 65% and 18%, respectively, in prior studies, with skin ulceration reported in one such study involving permanent particles. By contrast, Nexsphere-F™ was associated with transient skin discoloration in just 6.3% of procedures, resolving within 24 hours. A representative from NEXTBIOMEDICAL stated that publication in Radiology reflects strong international recognition of Nexsphere-F™'s clinical value and differentiation. The representative added that through the ongoing RESORB clinical trial in the United States, NEXTBIOMEDICAL plans to continue building the clinical evidence needed to help establish Nexsphere-F™ as a global standard of care in genicular artery embolization. SOURCE NEXTBIOMEDICAL CO., LTD. 21% more press release views with Request a Demo

Clinical ResultClinical Study

23 Jun 2026

·firstwordpharma.com

GSK and Spero's oral carbapenem is first to win FDA approval for cUTIs

GSK's decision to license Spero Therapeutics' antibiotic in 2022 despite a regulatory setback has now paid off. The US agency on Wednesday approved Utebzi (tebipenem pivoxil) to treat complicated urinary tract infections (cUTIs), the first oral carbapenem cleared for the indication. The antibiotic was cleared specifically for adults with cUTIs, including pyelonephritis, that are caused by certain susceptible pathogens who have limited or no other oral treatment options. Utebzi is expected to be available in the US by year-end. GSK's Chief Scientific Officer Tony Wood said the antibiotic "could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections.”With the threat of antimicrobial resistance (AMR) looming, GSK has continued to invest in antibiotics and antifungals, even when many of its big pharma peers largely backed away from the antimicrobials business (see – Spotlight On: GSK swims against the tide to address growing AMR crisis).Early study stoppageThe FDA nod for Utebzi comes almost exactly four years after the regulator initially rejected the antibiotic, determining that its data package was insufficient to support approval for cUTI and requested an additional trial.Months later, however, GSK licensed tebipenem from Spero for $66 million upfront. With the UK pharma's support, the partners ran the Phase III PIVOT-PO trial evaluating the oral antibiotic against intravenous (IV) imipenem cilastatin. Close to 1700 patients were randomised to receive either a 600-mg dose of Utebzi orally every six hours, or an IV 500-mg dose of imipenem cilastatin every six hours, for seven to 10 days. At a pre-specified interim analysis last year, PIVOT-PO was stopped early on the recommendation of an independent data monitoring committee (IDMC) because Utebzi achieved non-inferiority compared to the IV carbapenem on a composite measure of clinical cure plus microbiological eradication at the test-of-cure visit. GSK further elaborated on this clinical win in its ID Week presentation, reporting that of the 446 patients who received Utebzi, 58.5% achieved an overall success compared to a 60.2% overall success rate for imipenem cilastatin. Additionally, the oral antibiotic led to a 93.5% clinical response rate and a 60.3% microbiological response rate, compared with 95.2% and 61.3% response rates, respectively, for imipenem cilastatin.On the safety front, the most common side effects were diarrhoea, headache, nausea, abdominal pain and increased liver enzymes.

Phase 3Clinical ResultDrug ApprovalQualified Infectious Disease Product

18 Jun 2026

·www.biospace.com

GSK, Spero’s oral antibiotic wins first FDA nod for complicated UTI

iStock, masterzphotois After being rejected in June 2022, GSK paid Spero Therapeutics $66 million for an exclusive worldwide license to develop and commercialize the drug. It’s the second oral antibiotic GSK has brought to market since the beginning of last year. The FDA has given the go-ahead to GSK and Spero Therapeutics’ tebipenem pivoxil for the treatment of complicated urinary tract infections. The drug, which will be on U.S. shelves by year-end, will carry the brand name Utebzi. The U.S. records more than 3 million cases of complicated urinary tract infections (cUTIs) annually, GSK said in a news release on Wednesday . These treatments are unsuccessful in more than a third of these patients, often due to drug-resistant pathogens. Carbapenem antibiotics form somewhat of a last-line of defense for resistant infections, but have so far only been available intravenously. Utebzi is the first oral option of such an anti-infective, GSK said, and is indicated specifically for patients whose cUTI is caused by susceptible pathogens and who have limited or no alternative treatment options. The drug was originally developed by Spero Therapeutics and was previously rejected by the FDA in June 2022. The agency contended that the Phase 3 study the biotech had used to back its application “was insufficient to support approval,” according to a news release at the time. The regulator asked for another study to establish the drug’s efficacy. In December that year, GSK paid $66 million upfront and earmarked up to $750 million in milestones for an exclusive license to develop and commercialize the anti-infective globally except in Japan and certain Asian territories. GSK and Spero refiled their drug package for Utebzi in December 2025. Data from the Phase 3 PIVOT-PO study supported the FDA’s approval. A readout in October 2025 showed that Utebzi was non-inferior to intravenous imipenem-cilastatin , a broad-spectrum antibiotic commonly used for infections caused by bacteria. Patients in the Utebzi group saw a 58.5% overall treatment success rate , versus 60.2% in those who received the intravenous therapy. Ahead of this data drop, GSK in May 2025 announced that an independent data board recommended to stop PIVOT-PO ahead of schedule for efficacy. With Utebzi’s clearance on Wednesday, GSK has now notched a trifecta of infectious disease approvals over the past year and a half. In March 2025, the pharma secured the FDA’s go-ahead for the oral antibiotic Blujepa for uncomplicated urinary tract infections in female patients 12 years of age and up. Then, in December that year, Blujepa cleared another regulatory hurdle and expanded into uncomplicated urogenital gonorrhea, becoming the first new class of antibiotics for this indication in more than 30 years. GSK is the lone Big Pharma still involved in developing new antibiotics despite the threat of resistance. Approvals GSK’s Blujepa Opens First New Class of Gonorrhea Antibiotic in More Than 30 Years Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older. December 12, 2025 · 2 min read · Tristan Manalac Read more

Phase 3License out/inClinical ResultDrug Approval

100 Deals associated with Cilastatin Sodium/Imipenem

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-	Cilastatin Sodium/Imipenem	J01DH51	-

R&D Status

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Indication	Country/Location	Organization	Date
Coinfection	Australia	Sun Pharma ANZ Pty Ltd.	09 Jul 2026
Bacterial Infections	China	Merck & Co., Inc.	27 May 2000
Acute Bronchitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Acute prostatitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Adnexitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Arthritis	Japan	MSD KK (Tokyo)	30 Jun 1987
Cholangitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Cholecystitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Chronic prostatitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Cystitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Empyema	Japan	MSD KK (Tokyo)	30 Jun 1987
Intrauterine infection	Japan	MSD KK (Tokyo)	30 Jun 1987
Liver Abscess	Japan	MSD KK (Tokyo)	30 Jun 1987
Lung Abscess	Japan	MSD KK (Tokyo)	30 Jun 1987
Osteomyelitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Parametritis	Japan	MSD KK (Tokyo)	30 Jun 1987
Peritonitis	Japan	MSD KK (Tokyo)	30 Jun 1987
Pneumonia	Japan	MSD KK (Tokyo)	30 Jun 1987
Pyelonephritis	Japan	MSD KK (Tokyo)	30 Jun 1987
Secondary infection	Japan	MSD KK (Tokyo)	30 Jun 1987

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2025	Not Applicable	Osteoarthritis	9	TAPE with intraarterial imipenem-cilastatin + iodinated contrast	rqqbslnhjj(waiajxpfdc) = qpichpdslp hhsfvxsmlk (vpjrszbzhy ) View more	Positive	11 Jun 2025
NCT02321800 (APEKS-cUTI, Pubmed)	Phase 2	Complicated lower urinary tract infection	371	Cefiderocol	jncwrfwtyl(hifvnjjsdu) = jbemgcgvlp aegilrkctq (axeisrbgia )	-	01 Jan 2021
				Imipenem-cilastatin	jncwrfwtyl(hifvnjjsdu) = ekkkonkuji aegilrkctq (axeisrbgia )
NCT01721408 (Pubmed \| Ther Clin Risk Manag)	Phase 4	Complicated intra-abdominal infection	470	Tigecycline	scdjjjgjan(wygtvjutza) = nausea, drug ineffectiveness, postoperative wound infection, vomiting, and pyrexia were the most common adverse events in tigecycline-treated subjects qqqkymgeii (mslyzwtxso ) View more	-	01 Jan 2018
				Imipenem/cilastatin
NCT00589693 (Pubmed \| Crit Care)	Phase 3	Pneumonia, Ventilator-Associated	274	Doripenem	tkeevcflkp(xzusukmjht) = zxopothtwf kzzzldqqwq (owrvkslwvc, -5.0 to 18.5) View more	Negative	13 Nov 2012
				Imipenem-cilastatin	tkeevcflkp(xzusukmjht) = jrspuqycbr kzzzldqqwq (owrvkslwvc ) View more

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