Gracevit (sitafloxacin) / Daiichi Sankyo - LARVOL DELTA

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

Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease (clinicaltrials.gov) - P2 | N=12 | Enrolling by invitation | Sponsor: Beijing Chest Hospital

New P2 trial

A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial (ChiCTR) - P4 | N=610 | Sponsor: Shenzhen Third people's Hospital; Shenzhen Third people's Hospital

New P4 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Bioequivalence of sitafloxacin tablets in a randomized, open, two-cycle, double-cross fasting and postmeal clinical trial in healthy subjects (ChiCTR) - P=N/A | N=80 | Completed | Sponsor: Tongji Hosptial Affiliated to Tongji Medical College of Huazhong University fo Science and Technology; Tongji Hospital, Tongji Medical College, Huazho

New trial

Ultra-short treatment by advancing new regimens based on sitafloxacin and pyrazinamide for drug-susceptible pulmonary tuberculosis (UltraStar-SZ): A multi-arm, multi-stage, adaptive, multi-centre, randomised, controlled, open-label, non-inferiority trial (ChiCTR) - P1 | N=72 | Recruiting | Sponsor: Third People’s Hospital of Shenzhen; Third People’s Hospital of Shenzhen

New P1 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Reply: prolonged sitafloxacin and doxycycline combination regimen for treating infections by highly resistant Mycoplasma genitalium. (PubMed, J Antimicrob Chemother) - No abstract available

Journal • Infectious Disease

Non-tuberculous mycobacterial shoulder arthritis with acute exacerbation soon after initiation of immune checkpoint inhibitor: A case report. (PubMed, J Infect Chemother) - "A 75-year-old man was diagnosed with left shoulder arthritis caused by Mycobacterium intracellulare eight months before receiving ICI treatment and was treated with clarithromycin and ethambutol...Considering the suspected worsening of NTM arthritis, sitafloxacin was additionally administered, and surgical debridement was performed...After the arthritis symptoms decreased, atezolizumab plus bevacizumab was resumed and continued with no recurrence of arthritis. The NTM exacerbation on the day after ICI administration suggests the potential involvement of the PD-1/PD-L1 pathway in the pathogenesis of NTM; moreover, adverse inflammatory reactions to NTM were possibly triggered through the blockade of this pathway."

Checkpoint inhibition • IO biomarker • Journal • Nontuberculous mycobacteria • Immunology • Infectious Disease • Musculoskeletal Pain • Nontuberculous Mycobacterial Disease • Pain • Respiratory Diseases • Rheumatology

A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P4 | N=140 | Completed | Sponsor: Daiichi Sankyo | Recruiting ➔ Completed | N=268 ➔ 140 | Trial completion date: Dec 2024 ➔ Sep 2024

Enrollment change • Trial completion • Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Case of Mycoplasma genitalium Urethritis Refractory to Treatment (PubMed, Hinyokika Kiyo) - "A 28-year-old man was diagnosed with chlamydial urethritis by his previous doctor and was prescribed minocycline (MINO)...Upon arrival, pyuria was observed, and we suspected a relapse of chlamydial urethritis, and a single dose of 1,000 mg of azithromycin (AZM) was administered. Urinary gonorrhea/chlamydia PCR and urinary Mycoplasma genitalium (MG) PCR were performed, and only MG was positive. After diagnosis of MG urethritis, sitafloxacin (STFX) 100 mg for5 days, AZM 500 mg for3 days, and MINO 200 mg for7 days were prescribed, but urinary MG PCR did not become negative, and finally MG became negative after 14 days of STFX 100 mg was prescribed."

Journal • Infectious Disease • Pain