RESUMEN
Levofloxacin (LVX) is difficult to be naturally degraded by microorganisms in water, and its residues in water will pose significant risks to human health and ecological environment. In this study, Bi12O17Cl2 was used as the main body, Bi12O17Cl2/GO/Co3O4 composite photocatalyst was prepared by pyrolysis of zeolitic imidazolate framework-67 (ZIF-67) combined with in-situ precipitation method and used to degrade LVX. A sequence of characterizations shows that addition of Co3O4 and graphene oxide (GO) increases the visible light response range, improves the separation efficiency of photogenerated electrons and holes (e--h+) of photocatalyst, and thus improves the degradation efficiency of LVX. Under the optimal reaction conditions, the LVX degradation rate of Bi12O17Cl2/1.5GO/7.5Co3O4 can reach 91.2 % at 120 min, and its reaction rate constant is the largest (0.0151 min-1), which is 2.17, 13.14 and 1.53 times that of Bi12O17Cl2, Co3O4 and Bi12O17Cl2/7.5Co3O4, respectively, showing better photocatalytic performance. Simultaneously, the recycling stability of Bi12O17Cl2/1.5GO/7.5Co3O4 was also verified. The capture experiments and electron EPR test results showed that superoxide radicals (â¢O2-) and photogenerated holes (h+) were the primary active substances in the reaction process. Finally, combined with HPLC-MS results, the photocatalytic degradation pathway of LVX was derived. This work will provide a theoretical basis for the design of Metal Organic Frameworks (MOFs)-derivative modified Bi12O17Cl2-based photocatalysts.
RESUMEN
OBJECTIVES: Helicobacter pylori (H. pylori) is a globally prevalent bacterium that increases the risk of developing various gastrointestinal diseases, including gastric adenocarcinoma. This study aimed to evaluate the performances of real-time PCR assay in detecting H. pylori infection, as well as clarithromycin and levofloxacin resistance, in both stool and gastric biopsy specimens. METHODS: Stool and gastric biopsy specimens were collected from patients within one to three days post-hospitalization. All patients were analyzed for H. pylori infection and resistance to clarithromycin and levofloxacin using a real-time PCR based molecular assay. RESULTS: 169 patients (83 males) with a mean age of 43.6±13.1 years were included in the study. The prevalence of H. pylori was 89.9% (152/169) in stool and 90.5% (153/169) in gastric biopsy samples. The molecular diagnostics employed in this study exhibited a sensitivity of 99.3% and a specificity of 100%, resulting in a diagnostic accuracy rate of 99.6%. Resistance to clarithromycin was 36.1% (61/169) in stool and 44.4% (75/169) in gastric biopsy samples. The molecular tests for clarithromycin resistance demonstrated a sensitivity of 96.8% and a specificity of 86.8%, with an overall diagnostic accuracy of 90.5%. Furthermore, resistance to levofloxacin was 22.5% (38/169) and 26.6% (45/169) in stool and gastric biopsy samples, respectively. The molecular test demonstrated a sensitivity of 80.9% and a specificity of 94.3%, resulting in a diagnostic accuracy of 90.5%. CONCLUSION: The implementation of real-time PCR-based screening for H. pylori infection and resistance to clarithromycin and levofloxacin in the stool may enhance the success rate of eradication therapy.
RESUMEN
BACKGROUND: Antibiotics and bronchodilator drugs can be used together in respiratory distress caused by bacterial infections. Levofloxacin (LVX) and Salbutamol (SLB) can be used simultaneously in respiratory distress. However, there have been no investigations on how the concurrent use of SLB can affect the pharmacokinetics of LVX in rats. OBJECTIVE: The purpose of this study was to investigate the influence of SLB on the plasma and lung pharmacokinetics of LVX in rats. METHODS: A total of 132 rats were randomly assigned to two groups: LVX (n=66) and LVX+SLB (n=66). LVX (intraperitoneal) and SLB (oral) were administered to rats at doses of 50 and 3 mg/kg, respectively. The concentrations of LVX in the plasma and lungs were determined through the utilization of high-performance liquid chromatography along with UV. Pharmacokinetic parameters were assessed by non-compartmental analysis. RESULTS: The area under the curve from 0 to 16 h (AUC0-16), terminal elimination half-life, volume of distribution, total body clearance, and peak concentration of LVX in the plasma were 42.57 h*µg/mL, 2.32 h, 3.91 L/kg, 1.17 L/h/kg, and 23.96 µg/mL, respectively. There were no alterations observed in the plasma and lung pharmacokinetic parameters of LVX when co-administered with SLB. The AUC0-16 lung/AUC0-16 plasma ratios of LVX were 1.60 and 1.39 after administration alone and co-administration with SLB, respectively. CONCLUSION: The concentration of LVX in lung tissue was higher than that in plasma. SLB administration to rats did not affect the plasma and lung pharmacokinetics and lung penetration ratio of LVX. There is a need to reveal the change in the pharmacokinetics of LVX after multiple administration of both drugs and after administration of SLB by different routes.
Asunto(s)
Antibacterianos , Levofloxacino , Meningitis Bacterianas , Infecciones por Mycoplasma , Mycoplasma hominis , Humanos , Levofloxacino/uso terapéutico , Recién Nacido , Mycoplasma hominis/aislamiento & purificación , Antibacterianos/uso terapéutico , Infecciones por Mycoplasma/tratamiento farmacológico , Infecciones por Mycoplasma/diagnóstico , Meningitis Bacterianas/tratamiento farmacológico , Meningitis Bacterianas/diagnóstico , Meningitis Bacterianas/microbiología , Masculino , Ofloxacino/uso terapéutico , FemeninoRESUMEN
BACKGROUND: Fluoroquinolones are the most commonly prescribed antibiotics. Because of their known tendency to drive antimicrobial resistance, their prescribing patterns need to be more restricted. This study aimed to describe the clinical practice of fluoroquinolone prescription, dose adjustments for renal impairment patients and bacterial resistance profiles, eventually providing evidence-based recommendations to optimize antibiotic prescribing practices in the local population. METHODS: This retrospective, cross-sectional study was conducted at An-Najah National University Hospital in Palestine. The data were collected from admitted patients who were given ciprofloxacin or levofloxacin from July 2021 to June 2023. Data from 692 inpatients across various hospital departments were examined (409 for levofloxacin and 283 for ciprofloxacin). Statistical analysis was performed via IBM SPSS version 23.0 to summarize the demographic, clinical, and epidemiological data. RESULTS: The sociodemographic profile revealed diverse age distributions, with 25.4% and 39% older than 50 years for ciprofloxacin and levofloxacin, respectively. Ciprofloxacin was predominantly used in the oncology department (28.2%), with surgical prophylaxis (22.6%) and febrile or afebrile neutropenia (21.1%) being the most common indications. Levofloxacin was predominantly used in the medical ward (45.7%), mainly for lower respiratory tract infection (58.8%) and prophylaxis for bone marrow transplantation (16.5%). Enterococcus and methicillin-resistant Staphylococcus aureus were the most commonly isolated pathogens, with 62.5% of the isolates demonstrating resistance to ciprofloxacin. Moreover, extended-spectrum beta-lactamase-producing Enterobacterales were the most common pathogen isolated, with 33.3% being resistant to levofloxacin. Statistical analysis revealed a significant association between the choice of antibiotic and the approach to therapy. Levofloxacin was significantly more likely than ciprofloxacin to be used as empiric therapy (p < 0.001), whereas ciprofloxacin was more likely to be used as targeted therapy (p < 0.001). CONCLUSIONS: This study investigated prescribing practices and resistance to levofloxacin and ciprofloxacin in a large hospital in a developing country. According to the bacterial resistance profiles, we conclude that there is a need for hospital departments to exercise greater restraint on the use of these antibiotics. To this end, further studies addressing the clinical efficacy of fluoroquinolones against the current treatment guidelines to evaluate their appropriateness should be carried out.
Asunto(s)
Antibacterianos , Fluoroquinolonas , Levofloxacino , Centros de Atención Terciaria , Humanos , Estudios Retrospectivos , Estudios Transversales , Masculino , Persona de Mediana Edad , Femenino , Centros de Atención Terciaria/estadística & datos numéricos , Antibacterianos/uso terapéutico , Antibacterianos/farmacología , Adulto , Fluoroquinolonas/uso terapéutico , Fluoroquinolonas/farmacología , Anciano , Levofloxacino/uso terapéutico , Levofloxacino/farmacología , Ciprofloxacina/uso terapéutico , Ciprofloxacina/farmacología , Farmacorresistencia Bacteriana , Adulto Joven , Adolescente , Anciano de 80 o más Años , Pautas de la Práctica en Medicina/estadística & datos numéricos , Pruebas de Sensibilidad Microbiana , Medio Oriente/epidemiología , Bacterias/efectos de los fármacos , Bacterias/aislamiento & purificaciónRESUMEN
Multidrug-resistant TB (MDR-TB) is a form of tubercular disease caused by a strain of Mycobacterium tuberculosis complex that is resistant to rifampicin and isoniazid. Microbiologically diagnosed patients are started on an all-oral longer regimen or shorter regimen based on the Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India. Fluoroquinolones (FQs), being the cornerstone in the treatment of MDR-TB, are categorized as class A drugs. Levofloxacin (Lfx) administered at a dose of 11-14 mg/kg/day holds a strong bactericidal activity against Mycobacterium tuberculosis. FQs are associated with a wide range of adverse drug reactions, such as nausea, bloating, headache, dizziness, and insomnia. Tendon rupture, arthralgia though rare, can also occur due to Lfx. Even though arthralgia is commonly seen in patients on Lfx-associated treatment, only a few cases have been reported in India to date. We present a case series involving three cases of Lfx-induced arthralgia in patients of different age groups who are started on an all-oral longer regimen after they were diagnosed with MDR-TB. Based on the treatment protocol, patients were rechallenged or switched to other drugs in the replacement sequence as per the weight band.
RESUMEN
As the contamination and enrichment in food chain of levofloxacin (LV) antibiotics have caused a significant threat to life safety, the instant detection of LV has become an urgent need. Here, a PDI-functionalized imine-based covalent organic framework (PDI-COF300) was prepared by the electrostatic self-assembly method as fluorescent probe for smartphone visual detection of LV, which exhibited excellent fluorescence quantum yield (82.68%), greater stability, high sensitivity with detection limit of 0.303 µM. Based on the results of molecular docking and Stern-Volmer equation, the LV detection by PDI-COF300 was mainly a static quenching process through π-π stacked hydrophobic interactions and fluorescence resonance energy transfer. Besides, PDI-COF300 was applied to LV detection in environmental medium and milk samples with recoveries from 85.56% to 108.34% and relative standard deviations <2.70%. This work also provided a new general strategy for using PDI-COF in smartphone devices and fluorescent papers for LV fluorescence detection and microanalysis.
RESUMEN
Polyetheretherketone (PEEK) implants have emerged as a clinically favored alternative to titanium alloy implants for cranial bone substitutes due to their excellent mechanical properties and biocompatibility. However, the biological inertness of PEEK has hindered its clinical application. To address this issue, we developed a dual-functional surface modification method aimed at enhancing both osteogenesis and antibacterial activity, which was achieved through the sustained release of chondroitin sulfate (CS) and levofloxacin (LVFX) from a biomimetic polydopamine (PDA) coating on the PEEK surface. CS was introduced to promote cell adhesion and osteogenic differentiation. Meanwhile, incorporation of antibiotic LVFX was essential to prevent infections, which are a critical concern in bone defect repairing. To our delight, experiment results demonstrated that the SPKD/CS-LVFX specimen exhibited enhanced hydrophilicity and sustained drug release profiles. Furthermore, in vitro experiments showed that cell growth and adhesion, cell viability, and osteogenic differentiation of mouse calvaria-derived osteoblast precursor (MC3T3-E1) cells were significantly improved on the SPKD/CS-LVFX coating. Antibacterial assays also confirmed that the SPKD/CS-LVFX specimen effectively inhibited the growth of Escherichia coli and Staphylococcus aureus, attributable to the antibiotic LVFX released from the PDA coating. To sum up, this dual-functional PEEK implant showed a promising potential for clinical application in bone defects repairing, providing excellent osteogenic and antibacterial properties through a synergistic approach.
RESUMEN
Highlights S-scheme heterojunction was fabricated through in-situ solvothermal method 3D worm-like BOR and 3D rocky stone CNPO composite exhibited high photoactivity through â¢O2- 3D/3D junction occurred through bridging bond for efficient charge separation Waste H2O2 was turned into wealth â¢OH for mineralization of OTC and LVX Bi0 plasmon assisted stability and H2O2 decomposition and Ov influenced its production.
RESUMEN
OBJECTIVES: We aimed to assess whether there is a difference between ciprofloxacin and levofloxacin as prophylaxis in hematopoietic stem cell transplant (SCT) recipients. METHODS: This is a prospective, randomized trial in patients receiving SCT at Henry Ford Health in the United States of America. We randomly assigned patients (1:1) to receive ciprofloxacin or levofloxacin. The primary outcome was incidence of bloodstream bacterial infections (BSI) up to day 60 after SCT. RESULTS: Between June 4, 2018, and May 23, 2022, we randomly assigned 308 consecutive patients to receive ciprofloxacin (154 patients) or levofloxacin (154 patients). BSI was similar in both the ciprofloxacin and levofloxacin groups (18 [11.7%] vs 18 [11.7%]). Pneumonia was more frequent in the ciprofloxacin group compared to the levofloxacin group (18 [18%] vs 7 [23%]; relative risk 2.57, 95% CI 1.11-5.98; p = 0.028). There were no differences in neutrophil engraftment, fever, Clostridium difficile infection, relapse incidence, overall survival, nonrelapse mortality, length of stay post-SCT, or intensive care unit admission. CONCLUSION: Although both prophylaxis regimens demonstrated the same efficacy in SCT recipients, levofloxacin prophylaxis led to less pneumonia in the first 60 days post-SCT. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, NCT03850379.
RESUMEN
The use of nanocatalytic particles for the removal of refractory organics from wastewater is a rapidly growing area of environmental purification. However, little has been done to investigate the effects of nanoparticles on soil-plant systems with antibiotic contamination. This work assessed the effect of molybdenum disulfide (MoS2) on the soil-Phragmites communis system containing levofloxacin (LVX). The results showed that the addition of MoS2 had restoration potential for stressed plant. The MoS2 with catalytic activity promoted the transformation of LVX in rhizosphere soils. The transformation pathways of LVX in the different exposure groups were proposed. The continuous output of radicals in the high MoS2 dosage group facilitated the transformation of LVX to small molecule compounds, which were eventually mineralized. Moreover, the electron-density-difference analysis revealed the easier flow of electrons from the MoS2 surface towards the LVX molecules. This finding provides theoretical support for the application of nanocatalytic particles in ecological environments.
Asunto(s)
Disulfuros , Levofloxacino , Molibdeno , Nanopartículas , Contaminantes del Suelo , Suelo , Levofloxacino/química , Molibdeno/química , Disulfuros/química , Suelo/química , Nanopartículas/química , Contaminantes del Suelo/química , Contaminantes del Suelo/análisis , Antibacterianos/química , Poaceae , Rizosfera , CatálisisRESUMEN
Bloodstream infections (BSI) are one of the leading causes of morbidity and mortality in children and young adults receiving chemotherapy for malignancy or undergoing hematopoietic stem cell transplantation (HSCT). Antibiotic prophylaxis is commonly used to decrease the risk of BSI; however, antibiotics carry an inherent risk of complications. The aim of this manuscript is to review levofloxacin prophylaxis in pediatric oncology patients and HSCT recipients. We reviewed published literature on levofloxacin prophylaxis to prevent BSI in pediatric oncology patients and HSCT recipients. Nine manuscripts were identified. The use of levofloxacin is indicated in neutropenic children and young adults receiving intensive chemotherapy for leukemia or undergoing HSCT. These results support the efficacy of levofloxacin in pediatric patients with leukemia receiving intensive chemotherapy and should be considered in pediatric patients undergoing HSCT prior to engraftment.
Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Levofloxacino , Humanos , Levofloxacino/uso terapéutico , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Niño , Adolescente , Masculino , Preescolar , Femenino , Profilaxis Antibiótica/métodos , Neoplasias , Leucemia/terapia , Antibacterianos/uso terapéutico , Adulto , Adulto JovenRESUMEN
Purpose: The association between fluoroquinolone intake and Achilles tendinopathy (AT) or Achilles tendon rupture (ATR) is widely documented. However, it is not clear whether different molecules have the same effect on these complications. The purpose of this study was to document Achilles tendon complications for the most prescribed fluoroquinolones molecules. Methods: A literature search was performed on Pubmed, Cochrane, Embase, and Web of Science databases up to April 2023. Inclusion criteria: studies of any level of evidence, written in English, documenting the prevalence of AT/ATR after fluoroquinolone consumption and stratifying the results for each type of molecule. The Downs and Black's 'Checklist for Measuring Quality' was used to evaluate the risk of bias. Results: Twelve studies investigating 439,299 patients were included (59.7% women, 40.3% men, mean age: 53.0 ± 15.6 years). The expected risk of AT/ATR was 0.17% (95% CI: 0.15-0.19, standard error (s.e.): 0.24) for levofloxacin, 0.17% (95% CI: 0.16-0.19, s.e.: 0.20) for ciprofloxacin, 1.40% (95% CI: 0.88-2.03, s.e.: 2.51) for ofloxacin, and 0.31% (95% CI: 0.23-0.40, s.e.: 0.77) for the other molecules. The comparison between groups documented a significantly higher AT/ATR rate in the ofloxacin group (P < 0.0001 for each comparison). Levofloxacin and ciprofloxacin showed the same risk (P = n.s.). The included studies showed an overall good quality. Conclusion: Ofloxacin demonstrated a significantly higher rate of AT/ATR complications in the adult population, while levofloxacin and ciprofloxacin showed a safer profile compared to all the other molecules. More data are needed to identify other patient and treatment-related factors influencing the risk of musculoskeletal complications.
RESUMEN
The complicated loading process and easy falling off of powder catalysts still restrict the wide application of Photo-Fenton technology in practical water treatment. In this study, a magnetic fixed film plate column water treatment equipment is designed as a visible Photo-Fenton reactor to remove levofloxacin (LEV). The effect of magnetic force can ensure that the catalyst is firmly fixed, and the multi-level shallow column plate structure achieves full contact and efficient reaction between the catalyst and wastewater. Simultaneously, the Cu0/CuFe2O4 (STCCF) utilizes Cu0 to construct an S-scheme electron transfer channel, which improves the separation efficiency of photo-generated carriers and provides sufficient photo-generated electrons for the reduction of Fe (â ¢) and Cu (â ¡). The pseudo-first-order reaction kinetic constant k for the degradation of LEV in the visible Photo-Fenton system is 0.0349 min-1, which is 15.9 times that of the photocatalytic system and 4.8 times that of the Fenton system. After continuous operation for 72 h, the magnetic fixed film plate column reactor can still remove more than 90 % of LEV and 82 % of COD in the secondary effluent of simulated antibiotic pharmaceutical wastewater treatment process, and the effluent is stable and meets the standard. The magnetic fixed film plate column reactor can be used for advanced treatment of antibiotic pharmaceutical wastewater. This study provides a new insight into the application of the Photo-Fenton process.
RESUMEN
BACKGROUND: Patients with cystic fibrosis commonly suffer from lung infections caused by Pseudomonas aeruginosa. Recently, the Levofloxacin (LVF) nebulizing solution (Quinsair®) has been prescribed for the antimicrobial management. The sustained-release (SR) dry powder formulation of LVF is a convenient alternative to Quinsair®. It has the potential to enhance patient convenience and decrease the likelihood of drug resistance over time. OBJECTIVE: In this paper, we set forth to formulate and evaluate the potential application of sodium alginate (SA) and sodium carboxymethylcellulose (SCMC) for sustained pulmonary delivery of LVF. METHODS: The spray-dried (SD) LVF microparticles were formulated using SCMC and SA along with L-leucine (Leu). The microparticles were analyzed in terms of particle size, morphology, x-ray diffraction (XRD), in-vitro drug release, and aerodynamic properties. Selected formulations were further proceeded to short-term stability test. RESULTS: The polymer-containing samples displayed process yield of 33.31%-39.67%, mean entrapment efficiency of 89% and volume size within the range of 2-5 µm. All the hydrogel microparticles were amorphous and exhibited rounded morphology with surface indentations. Formulations with a drug-to-excipient ratio of 50:50 and higher, showed a 24-h SR. The aerodynamic parameters were fine particle fraction and emitted dose percentage ranging between 46.21%-60.6% and 66.67%-87.75%, respectively. The short-term stability test revealed that the formulation with a 50:50 drug-to-excipient ratio, containing SA, demonstrated better physical stability. CONCLUSION: The selected formulation containing SA has the potential to extend the release duration. However, further enhancements are required to optimize its performance.
RESUMEN
Stability and potency improvement have been reported by reacting levofloxacin (LF) with citric acid (CA) in a (1:1) molar ratio. However, CA is known to be irritant to the gastrointestinal tract and should be minimized. In a novel approach, this experiment aimed to prepare LF - CA salt with reduced CA, the (2:1) molar ratio, study the structure, and investigate its solubility, stability, and potency improvement. Solvent-dropped grinding and slow evaporation methods were used to prepare the new ratio composition salt, characterized by electrothermal, differential scanning calorimetry, and powder X-ray diffractometry to confirm the physically new solid-state formation. Next, Fourier transform spectrophotometry identified the chemical interaction between LF and CA. After that, a comprehensive structural study using single-crystal X-ray diffractometry determined the 3D structure of the new salt, which determined the solid physicochemical behavior. Finally, stability, solubility, and potency tests were done to investigate the benefits of the new LF-CA composition. As a result, this experiment successfully synthesized the salt, which bound 4.5 water molecules, named LFCA (2:1) - 4.5 hydrate. This new solid-state salt was comparable with the established (1:1) molar ratio in solubility, stability, and potency, higher than LF alone. Hereafter, with a reduced CA portion, this new composition holds potential for further development in drug formulation as a stable, safer, and more efficient antibiotic.
RESUMEN
Extrapyramidal symptoms (EPS) that include akathisia, dystonia, pseudoparkinsonism, and dyskinesia are abnormal movements commonly induced by antipsychotic medications. These symptoms are also associated with specific non-antipsychotic agents. This case report describes a case of a 9-year-old boy on antibiotics treatment that developed EPS. A 9-year-old boy presented to the emergency department of Imam Hossein Children>s Hospital with chief complaints of trismus, difficulty speaking, and tongue protrusion. One week before these presentations, he had been prescribed Tavanex® (levofloxacin) and clindamycin. His symptoms improved after the withdrawal of antibiotics and administering Biperiden, and he was discharged in good condition. On a follow-up visit one week after discharge, no remaining symptoms were present, and he was in good condition. Based on the questions in the Naranjo criteria, levofloxacin receives a score of 7 and is a probable cause of adverse drug reaction (ADR). Clindamycin, with a score of 6, is also a probable cause for this adverse drug reaction, but clinical judgment was in favor of levofloxacin as the culprit. Clinicians should be aware of the potential EPS of levofloxacin at standard doses. Effective management of adverse events is necessary to ensure patient safety and optimal outcomes.
RESUMEN
One of the fluoroquinolone antibiotics, levofloxacin (LEV), is used to treat a variety of illnesses leading to oxidative stress and cellular damage. Peel from Punica granatum is a waste product abundant in phytochemicals with various biological activities. This study aimed to evaluate P. granatum peel extract's (PGPE) potential to mitigate oxidative stress, inflammation, apoptosis, and liver damage caused by LEV. There were four groups of rats: control, PGPE, LEV, and PGPE + LEV, respectively, and they were orally administered their daily treatments for 2 weeks. Results revealed that PGPE has a large number of phytochemical components with high antioxidant activity. PGPE intake alone enhanced the antioxidant status and decreased oxidative stress. On the other hand, pretreatment of the LEV group with PGPE restored oxidative stress, antioxidant enzymes, glutathione content, liver function biomarkers, and hematological parameters. Also, normalization of gene expressions (cyclooxygenase-2, transforming growth factor-beta1, caspase-3, heme oxygenase-1, B cell lymphoma-2, interleukin [IL]-10, and IL-1) and improvement in liver architecture, and immunohistochemical alpha-smooth muscle actin, were seen in comparison to the LEV group. Conclusively, PGPE exhibits strong anti-inflammatory, antiapoptotic, and antioxidant properties that shield rat liver from the damaging effects of LEV and offer a fresh viewpoint on the application of fruit waste products.
RESUMEN
BACKGROUND: Nemonoxacin malate is a novel non-fluorinated quinolone for oral and intravenous (IV) administration. This phase 3, multicentre, randomised, double-blind, double-dummy, parallel-controlled clinical trial (NCT02205112) evaluated the efficacy and safety of IV nemonoxacin vs. levofloxacin for the treatment of community-acquired pneumonia (CAP) in adult patients. METHODS: Eligible patients were randomised to receive 500 mg nemonoxacin or levofloxacin via IV infusion, once daily for 7-14 days. The primary endpoint was the clinical cure rate at the test-of-cure (TOC) visit in the modified intent-to-treat (mITT) population. Secondary efficacy and safety were also compared between nemonoxacin and levofloxacin. RESULTS: Overall, 525 patients were randomised and treated with nemonoxacin (n = 349) or levofloxacin (n = 176). The clinical cure rate was 91.8% (279/304) for nemonoxacin and 85.7% (138/161) for levofloxacin in the mITT population (P > 0.05). The clinical efficacy of nemonoxacin was non-inferior to levofloxacin for treatment of CAP. Microbiological success rate with nemonoxacin was 88.8% (95/107) and with levofloxacin was 87.8% (43/49) (P > 0.05) at the TOC visit in the bacteriological mITT population. The incidence of drug-related adverse events (AEs) was 37.1% in the nemonoxacin group and 22.2% in the levofloxacin group. These AEs were mostly local reactions at the infusion site, nausea, elevated alanine aminotransferase/aspartate aminotransferase (ALT/AST), and QT interval prolongation. The nemonoxacin-related AEs were mostly mild and resolved after discontinuation of nemonoxacin. CONCLUSIONS: Nemonoxacin 500 mg IV once daily for 7-14 days is effective and safe and non-inferior to levofloxacin for treating CAP in adult patients.