Gracevit (sitafloxacin) / Daiichi Sankyo - LARVOL DELTA

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

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

An overview of potential combinations therapies with ceftriaxone as a treatment for gonorrhea. (PubMed, Expert Rev Anti Infect Ther) - "Of these 16 antimicrobials, we reject antimicrobials such as fosfomycin due to poor clinical efficacy and tigecycline due to its considerably longer half-life which would likely select for tetracycline resistance. The most promising agents for combination with ceftriaxone are zoliflodacin, delafloxacin, sitafloxacin, eravacycline and possibly gepotidacin and gentamicin. Clinical studies should be conducted to evaluate the efficacy of these combinations on the eradication of N. gonorrhoeae and their impact on AMR in N. gonorrhoeae and other bacterial species."

Journal • Review • Infectious Disease

Pharmacokinetics and Safety Evaluation of a New Generic Sitafloxacin: A Phase I Bioequivalence Study in Healthy Chinese Participants. (PubMed, Clin Pharmacol Drug Dev) - "No serious adverse events were observed in this study. Therefore, the findings indicate that generic and original sitafloxacin tablets have comparable bioequivalence and safety profiles."

Journal • P1 data • PK/PD data

SUSCEPTIBILITY-GUIDED THERAPY VERSUS EMPIRIC THERAPY IN PATIENTS WITH HELICOBACTER PYLORI TREATMENT FAILURES: A LARGE LONGITUDINAL POPULATION-BASED STUDY (SGT-HP TRIAL) (DDW 2025) - "Antibiotic resistance rates were 42.9% for metronidazole, 35.1% for levofloxacin, 24.9% for clarithromycin, 2.9% for amoxicillin, and 0.4% for tetracycline as demonstrated in Table 1. Multivariate analysis demonstrated that MDR H. pylori strains (OR 8.59, 95%CI 2.97-24.80, p<0.001) and sequential therapy as first-line treatment (OR 11.19, 95%CI 1.35-92.73, p=0.025) were significantly associated with treatment failure, while vonoprazan bismuth quadruple therapy was a protective factor for treatment failure (OR 0.06, 95%CI 0.01-0.47, p=0.007)...For empiric therapy after treatment failures, furazolidone-based quadruple therapy yielded the highest eradication rate (83.3%), followed by sitafloxacin-based therapy (75%), whereas CLR-containing regimens provided the lowest eradication rates (53.9%)... Bismuth quadruple therapy was the most used regimen for SGT, whereas furazolidone-based quadruple therapy yielded the highest eradication rate for empiric treatment. SGT is a..."

Clinical • Gastric Cancer • Infectious Disease • Oncology • Solid Tumor

Efficacy and Safety of Antimicrobial Medications in Treating Infections Caused by Extended-Spectrum; -Lactamase-Producing Enterobacteriaceae: A Systematic Review and Network Meta-analysis (ISPOR 2025) - "In these pairwise comparisons, Sitafloxacin and Ceftolozane-tazobactam showed the best clinical outcomes in comparison to piperacillin-tazobactam, while Plazomicin excelled in microbiological cure. However, Ertapenem and Cefepime were associated with higher ADRs and mortality, respectively.Keywords: Network meta-analysis, Extended-Spectrum β-Lactamase, Enterobacteriaceae, Efficacy and Safety"

Retrospective data • Review • Infectious Disease

Establishing Sitafloxacin Epidemiological Cut-off Values (ECOFFs) for Clinical Bacterial Isolates. (PubMed, Infect Drug Resist) - "The MIC ECOFF for P. mirabilis was classified as tentative. For S. pneumoniae, the correlation between zone diameters and MICs was insufficient to establish a zone diameter ECOFF."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia

Effect of Sitafloxacin and Amikacin Liposome Inhalation Suspension on Clarithromycin-Resistant Pulmonary Mycobacterium avium Complex Disease: A Case Series. (PubMed, Cureus) - "Sputum culture negativity was achieved in two patients, both under 65 years old and without cavitary lesions. These findings suggest the potential efficacy of STFX and ALIS as adjuncts to GBT for CAM-resistant pulmonary MAC disease, particularly in younger patients with non-cavitary disease."

Journal

Outcomes of sequential therapy with minocycline and sitafloxacin versus sitafloxacin monotherapy for Mycoplasma genitalium infections (AUA 2025) - "However, it is unclear whether sequential therapy with minocycline (a tetracycline antibiotic) and sitafloxacin (a fluoroquinolone antibiotic) is effective against M. genitalium. Sequential therapy with minocycline and sitafloxacin cured M. genitalium at a higher rate than sitafloxacin monotherapy and was as effective as in previous reports of sequential therapy with doxycycline and moxifloxacin. This regimen may be an option for treating M. genitalium infection."

Monotherapy • Gastrointestinal Disorder • Infectious Disease

Correlation Between Dissolution Profiles of Salt-Form Drugs in Biorelevant Bicarbonate Buffer and Oral Drug Absorption: Importance of Dose/ Fluid Volume Ratio. (PubMed, Pharm Res) - "The use of clinical Dose/FV was important for improving the correlation between the biorelevant dissolution profiles and Fa for salt-form drugs."

Journal

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

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

Sitafloxacin monotherapy vs standard rifampicin-doxycycline dual therapy for uncomplicated brucellosis: a multicentre, open-label, randomised, non-inferiority trial (ESCMID Global 2025) - No abstract available

Clinical • Head-to-Head • Monotherapy

Population Pharmacokinetics and Pharmacodynamics of Sitafloxacin in Plasma and Alveolar Epithelial Lining Fluid of Critically Ill Thai Patients With Pneumonia. (PubMed, Pharmacol Res Perspect) - "Results from Monte Carlo simulations showed that the maximum approved dose of sitafloxacin 100 mg q 12 h provided > 90% PTA and CFR in both plasma and ELF. The current maximal dosing of sitafloxacin provided adequate exposure in plasma and ELF for the treatment of critically ill Thai patients with pneumonia."

Journal • PK/PD data • Infectious Disease • Pneumonia • Respiratory Diseases

Outcomes of Sequential Therapy With Minocycline and Sitafloxacin Versus Sitafloxacin Monotherapy for Mycoplasma genitalium Infections. (PubMed, Int J Urol) - No abstract available

Journal • Monotherapy • Infectious Disease

Efficacy of Doxycycline-Sitafloxacin Sequential Therapy for Urogenital Mycoplasma genitalium Infection in Nanjing, China. (PubMed, Sex Transm Dis) - "Doxycycline-sitafloxacin sequential therapy was well tolerated and effective against most urogenital Mg infections in Nanjing and may provide an option for treatment."

Journal • Infectious Disease • Urology

Model-guided development of pharmacokinetic/pharmacodynamic cut-offs and evaluation of sitafloxacin dosing regimens against target pathogens. (PubMed, Front Pharmacol) - "For the other four strains, the dosing-regimen-dependent sitafloxacin PK/PD cut-offs were 0.06, 0.06 and 0.125 mg/L, respectively (CFRs = 56.3∼76.9%). Our findings suggest that sitafloxacin PK/PD cut-offs of S ≤ 0.06 mg/L and R > 0.125 mg/L should be used against these five strains and that the sitafloxacin dosing regimens (50 mg q12 h, 100 mg q24 h and 100 mg q12 h) have the expected efficacy against Streptococcus pneumoniae-related infections, but the efficacy against Pseudomonas aeruginosa-associated infections needs to be verified in clinical practice."

Journal • PK/PD data • Infectious Disease • Pneumococcal Infections • Pneumonia

Mycobacterium goodii pulmonary disease in an immunocompetent patient: A case report and literature review. (PubMed, J Infect Chemother) - "The patient was responded well to the initial therapy with amikacin, imipenem/cilastatin, doxycycline, sulfamethoxazole/ trimethoprim, and clarithromycin, followed by 18 months of ambulatory treatment with doxycycline, sulfamethoxazole/ trimethoprim, clarithromycin, and sitafloxacin. In this case, the development of M. goodii pulmonary disease is might be associated with the history of gastrectomy. For identifying the pathogen, MALDI-TOF MS and whole genome sequencing analysis were useful and the intensive initial treatment in accordance with the drug susceptibility testing was successful."

Journal • Cough • Infectious Disease • Peptic Ulcer • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Successful Treatment of Refractory Mycobacterium avium Complex Pulmonary Disease With Sitafloxacin After Failed Amikacin Liposome Inhalation Suspension Therapy. (PubMed, Cureus) - "Following the initiation of STFX, the patient showed significant clinical improvement with resolution of hemoptysis within three months, achieving sustained culture conversion, which has persisted for over two years. This case highlights the potential role of STFX as an effective therapeutic option in the management of refractory MAC pulmonary disease, particularly in cases where guideline-based treatments, including ALIS, have failed."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Full-Mouth Disinfection Using Oral Sitafloxacin for Stage III and IV Grade C Periodontitis With High Bacterial Load: A Case Series. (PubMed, Cureus) - "The results showed marked improvements in probing pocket depth, bleeding on probing, and inflamed periodontal surface area, with substantial reductions in red complex bacteria. This approach often eliminates the need for periodontal surgery, even in deep pockets, suggesting FMD with STFX as an effective nonsurgical alternative for severe periodontitis with significant bacterial load."

Journal • Dental Disorders • Periodontitis