Gracevit (sitafloxacin) / Daiichi Sankyo - LARVOL DELTA

A PAN-USR TB Multi-Center Trial (clinicaltrials.gov) - P3 | N=610 | Recruiting | Sponsor: Shenzhen Third People's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Challenges and Efficacy of Amikacin Liposome Inhalation in Real-World Refractory Mycobacterium avium Complex Pulmonary Disease. (PubMed, Cureus) - "Prior treatment regimens primarily involved azithromycin- or clarithromycin-based therapies, supplemented with sitafloxacin, with a median treatment duration of five years. These findings highlight the challenges of managing refractory MAC pulmonary disease in a real-world setting and emphasize the importance of considering patient characteristics, including radiographic patterns and baseline health, when initiating ALIS therapy. Adverse events were frequent but manageable with appropriate monitoring and adjustments."

Journal • Real-world evidence • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases

Challenges and Efficacy of Amikacin Liposome Inhalation in Real-World Refractory Mycobacterium Avium complex Pulmonary Disease (APSR 2025) - "Prior to ALIS initiation, patients had received macrolide-based regimens (azithromycin or clarithromycin) with sitafloxacin for a median duration of five years. While generally tolerable, the adverse event profile warrants careful monitoring. These findings highlight the importance of patient selection and potentially earlier ALIS intervention, particularly in patients with NB pattern disease."

Clinical • Real-world • Real-world evidence • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases

Clinical efficacy of sitafloxacin-containing regimens for Mycobacterium avium complex pulmonary disease. (PubMed, BMC Pulm Med) - No abstract available

Journal • Pulmonary Disease • Respiratory Diseases

In Vitro Activity of Sulfamethoxazole-Trimethoprim, Amikacin, Oxazolidinones, Fluoroquinolones and Fidaxomicin against Isolates of Nocardia. (PubMed, ACS Omega) - "This study evaluates the in vitro activity of common and potential antimicrobials, including Trimethoprim-sulfamethoxazole, Amikacin, Oxazolidinones (Linezolid, Tedizolid, Contezolid), Fluoroquinolones (Moxifloxacin, Levofloxacin, Sitafloxacin), Rifampicin, and Fidaxomicin against 51 clinical Nocardia isolates. These findings highlight the need for tailored treatment strategies based on species-specific susceptibility and resistance profiles and suggest Fidaxomicin and Sitafloxacin as promising options. Further clinical validation is warranted to optimize therapeutic outcomes."

Journal • Preclinical • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacy of a 7-day vonoprazan, sitafloxacin, and amoxicillin triple therapy as a fourth-line salvage regimen for refractory Helicobacter pylori infection. (PubMed, BMC Gastroenterol) - No abstract available

Journal • Infectious Disease

In vitro evolution provides insights into mechanisms of Mycoplasma genitalium resistance to moxifloxacin. (PubMed, J Antimicrob Chemother) - "Mutations in multiple genes conferring fluoroquinolone resistance appeared with regularity in vitro. Findings of an additive effect for ParC/GyrA changes, and greater effectiveness of sitafloxacin against resistant bacteria compared with moxifloxacin, are both consistent with clinical data. Improved understanding of fluoroquinolone resistance will inform the development of diagnostic assays predicting fluoroquinolone susceptibility."

Journal • Preclinical

Characteristics of Successful Third-Line Eradication of Helicobacter pylori based on Antibiotic Susceptibility. (PubMed, Asian Pac J Cancer Prev) - "VPZ, AMX, and STFX regimens were the most common and effective regimens, with female and AMX-sensitive patients more likely to have successful third-line eradication."

Journal • Infectious Disease

Improving Levothyroxine Adherence in an Elderly Polypharmacy Patient: A Multifaceted Intervention (ATA 2025) - "Introduction : Methimazole achieves high three-month compliance rates (~83%), thanks to once-daily dosing and low burden 1)...Current medications included levothyroxine, sitafloxacin, clofazimine, and entecavir, with a history of numerous antibiotics...Additionally, pharmacist-supported TSH monitoring programs reduced non-compliance from 79 to 18%, with 60% of patients actively managing dosing 5). This case emphasizes that to improve levothyroxine adherence in complex elderly patients, a multifaceted approach is essential—from using patient-friendly formulations and digital reminders to integrating pharmacist-led TSH monitoring."

Adherence • Clinical • Late-breaking abstract • Alzheimer's Disease • Atrial Fibrillation • Cardiovascular • Cognitive Disorders • Fatigue • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis

In vitro activity of sulbactam in combination with other antimicrobial agents against extensively drug-resistant Acinetobacter baumannii. (PubMed, Microbiol Spectr) - "Sixty-two clinical isolates of XDR A. baumannii were tested for minimal inhibitory concentrations (MICs) of SUL, amikacin (AMI), ciprofloxacin, colistin (COL), fosfomycin (FOS), gentamicin, meropenem (MER), rifampicin (RIF), sitafloxacin (SIT), and tigecycline (TIG) using broth microdilution. Time-kill assays showed that the four-drug combination of SUL/fosfomycin/amikacin/meropenem had sustained bactericidal activity over 24 hours. While SUL-based combinations showed variable synergy, further studies are needed to determine their clinical potential."

Journal • Preclinical • Infectious Disease

Endoscopically confirmed treatment progression in Mycoplasma genitalium-induced proctitis:a case report (PubMed, Nihon Shokakibyo Gakkai Zasshi) - "Sitafloxacin (200mg/day) was administered for 2 weeks, after which the bloody stools and fever resolved...To date, no reports have described endoscopic images of M. genitalium-induced proctitis. This was a valuable case in which we followed the treatment progression of M. genitalium-induced proctitis endoscopically."

Journal • Colorectal Cancer • Cytomegalovirus Infection • Infectious Disease • Nephrology

Elderly-USR: Ultra-Short Regimen for Elderly DS-TB (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Shenzhen Third People's Hospital

New P3 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial (ChiCTR) - P=N/A | N=610 | Not yet recruiting | Sponsor: Shenzhen Third people's Hospital; Shenzhen Third people's Hospital | Phase classification: P4 ➔ P=N/A

Phase classification • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Phenotypic and genotypic profiles of clinical isolates of various Nocardia species to carbapenems and fluoroquinolones. (PubMed, J Antimicrob Chemother) - "Nocardia spp. exhibited varying patterns of susceptibility to carbapenems and fluoroquinolones respectively. Importantly, different Nocardia spp. exhibited different patterns of susceptibility to carbapenems and fluoroquinolones, respectively."

Journal

Susceptibility of Neisseria gonorrhoeae to Zoliflodacin and Quinolones in Hyogo Prefecture, Japan. (PubMed, Pathogens) - "In addition to ZFD, we investigated the susceptibility of N. gonorrhoeae strains to ceftriaxone (CTRX), ciprofloxacin (CPFX), garenoxacin (GRNX), and sitafloxacin (STFX). ZFD showed potent antimicrobial activity against N. gonorrhoeae strains that are highly resistant to quinolones. It may become a new option in the treatment of gonococcal infections."

Journal • Infectious Disease

Disseminated Mycobacterium abscessus Infection in a Three-Year-Old Girl With CHARGE Syndrome: A Case Report and Literature Review. (PubMed, Cureus) - "Following microbiologic diagnosis, treatment was started with azithromycin and imipenem/cilastatin, along with exchanges of the intravenous device. However, subsequent deterioration of her condition required the admission to the intensive care unit and finally led to the introduction of a four-agent regimen with azithromycin, amikacin, linezolid, and tigecycline, whose sensitivity was confirmed later. After the initiation of sensitive antimicrobial therapy, she gradually recovered and was discharged with oral azithromycin and sitafloxacin...Although her immune function showed no abnormalities, we identified several predisposing factors related to her post-septic condition and her congenital medical history through an investigation of her clinical features with a literature review. While some previous cases of disseminated rapid-growing mycobacterial infections were successfully managed by intravascular device removal alone, this case underscores the need for tailored..."

Journal • Critical care • Infectious Disease • Nontuberculous Mycobacterial Disease • Otorhinolaryngology • Pediatrics • Respiratory Diseases

Infection in glaucoma drainage implant caused by macrolide-resistant Mycobacterium abscessus subsp. abscessus. (PubMed, Diagn Microbiol Infect Dis) - "Infection recurred, requiring surgical debridement and prolonged therapy with amikacin, clofazimine, and sitafloxacin based on susceptibility results. The organism's ability to form biofilms and resist multiple antimicrobials-especially through inducible macrolide resistance-complicates treatment. Early removal of infected devices and susceptibility-guided antimicrobial selection are essential for infection control."

Journal • Glaucoma • Infectious Disease • Ophthalmology

Eradication of Intracellular Staphylococcus aureus Persisters via On-Site Antibiotic Delivery by Poly(amino acid) Nanoparticles. (PubMed, ACS Appl Mater Interfaces) - "Sitafloxacin, rifampicin, and polymyxin B were identified from a panel of 11 antibiotic candidates and individually loaded into the F(AM) platform. Compared with free antibiotics, the drug-loaded F(AM) nanoparticles notably improved their intracellular bactericidal activity. Collectively, this study highlights F(AM) as a robust and versatile platform for overcoming intracellular barriers and restoring antibiotic efficacy, offering a valuable tool for antipersister strategies and intracellular pharmacokinetic investigations."

Journal • Infectious Disease

Rise and Demise: Carrier-Free Sitafloxacin-Sugar Nanoparticles Targeting Stationary Phase Staphylococcus aureus (ASM Microbe 2025) - "Sita shows strong activity against stationary S. aureus, whether in planktonic form, biofilms, or SAC, which is further enhanced by glu, fru, or man. We were able to form a carrier-free ND made of sita plus either one of those sugars. Targeting stationary S. aureus with these NDs may hold the potential to overcoming persistent infections."

Infectious Disease

A Retrospective Study of Clinical Characteristics and Treatment Outcomes of Sexually Transmitted Mycoplasma and Ureaplasma Species in a Japanese Clinic, 2023-2024 (ASM Microbe 2025) - "Of 75 MG-positive cases, 70 received treatment, predominantly with minocycline plus sitafloxacin (n=46), achieving a 68.8% (22/32) success rate. Variable MG treatment success rates underscore the need for enhanced diagnostic and treatment strategies, including antimicrobial susceptibility testing. While at least half of MH, UP, and UU infections were symptomatic requiring treatment, the long-term implications of asymptomatic infections remain unclear. With 18.9% of testing prompted by partner positivity and 43% lacking test-of-cure, our findings emphasize the importance of comprehensive testing and treatment follow-up to prevent transmission."

Retrospective data • Infectious Disease

A case report of peritoneal dialysis-associated peritonitis caused by Mycobacterium mageritense. (PubMed, IJID Reg) - "Based on susceptibility testing, treatment was initiated with trimethoprim/sulfamethoxazole (TMP/SMX) (80 mg/400 mg) 5 mg/kg every 24 hours in combination with minocycline 100 mg every 12 hours, which was subsequently changed to TMP/SMX plus faropenem 200 mg every 8 hours due to nausea caused by minocycline...We switched to TMP/SMX, imipenem/cilastatin 500 mg every 12 hours, and used linezolid 600 mg every 12 hours, which was later replaced with amikacin, guided by therapeutic drug monitoring...We treated the patient with TMP/SMX and sitafloxacin 100 mg every 24 hours, which was well-tolerated...Our findings underscore the importance of suspecting non-tuberculous mycobacteria in PD catheter-related infection and considering the early inclusion of acid-fast bacillus culture. Given the diagnostic challenges and the complexity of managing multi-drug antimicrobial therapy in patients with renal dysfunction, we recommend early catheter removal."

Journal • Chronic Kidney Disease • Diabetic Nephropathy • Infectious Disease • Nephrology • Nontuberculous Mycobacterial Disease • Renal Disease • Respiratory Diseases

Efficacy of Vonoprazan-Based Triple Therapy with Sitafloxacin and Amoxicillin for Third-Line Helicobacter pylori Eradication: A Multicenter Prospective Analysis on Drug Resistance and gyrA Mutations. (PubMed, Dig Dis) - "Overall, the 7-day VAS regimen exhibited excellent safety profile and efficacy as a third-line eradication treatment, even against gyrA mutation-positive H. pylori strains."

Journal • Infectious Disease • Pain

Structural insight in understanding the impact of mutation at position 88 and 94 of DNA gyrase A of Mycobacterium tuberculosis in developing resistance against delafloxacin. (PubMed, J Biol Phys) - "Based on literature information on drug-resistance related study for DNA gyrase, we generated 4 different mutant models 3ILW_G88A, 3ILW_G88C, 3ILW_D94G, and 3ILW_D94H by inserting two mutations at each position 88 and 94 in DNA gyrase chain A. Antibiotics Clinafloxacin, Gatifloxacin, Moxifloxacin, Sitafloxacin, Prulifloxacin, Besifloxacin, Delafloxacin, Ozenoxacin were docked with 3ILW_wild to understand their stability, binding affinity, and interaction pattern with the wild-type DNA gyrase (3ILW_wild). It is worth noting that mutation at position 94 of DNA gyrase A has a very profound effect as it shows a positive contribution towards increased resistance due to reduced binding affinity with delafloxacin. This study explains the structural changes and mechanism behind the resistance against Delafloxacin, and may also guide the structural changes required in existing Delafloxacin or other antibiotics to develop new therapeutics to overcome the issue of resistance."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Clinical Effectiveness of Penicillin-Free Therapies in First-Line and Rescue Treatments for Helicobacter pylori: A Systematic Review. (PubMed, Antibiotics (Basel)) - "Background and Aims: Amoxicillin is one of the most effective antibiotics for treating Helicobacter pylori infections and is widely used in first-line treatment regimens...Key findings demonstrated high eradication rates with bismuth-based quadruple therapies (88-97%), doxycycline-based regimens (86%), and quinolone-based therapies (75-100%), with Sitafloxacin exceeding 90% efficacy. Minocycline-based regimens also showed promising outcomes, with eradication rates between 80% and 85%...Vonoprazan-based therapy is an effective regimen. Combined with clarithromycin and metronidazole, vonoprazan enhances eradication rates and demonstrates effectiveness, including in clarithromycin-resistant strains."

Journal • Review • Allergy • Immunology • Infectious Disease

Bisphosphonate-Conjugated Sitafloxacin for Treatment of Staphylococcus aureus Infection Associated with Cortical Bone Screws: Case Series in Sheep Model. (PubMed, Pharmaceuticals (Basel)) - "Sheep 1 only received vancomycin, starting on day two. EM confirmed the presence of bacteria resorbing bone and replicating in biofilm in Sheep 1, while antibiotic-killed bacteria with ruptured septal planes were seen in Sheep 2. This study demonstrates the feasibility of HBCS therapy in a clinically relevant animal model and provides guidance on future efficacy studies, such as the use of an inoculum of 103 CFU per screw, the initiation of antibiotic treatment commencing at the time of surgery, and the usability of antibiotic-killed bacteria within altered glycocalyx observed by TEM as a potential biomarker for HBCS efficacy."

Journal • Infectious Disease • Musculoskeletal Diseases • Orthopedics