gemifloxacin and Pneumonia

Community-acquired pneumonia (CAP) is a lung infection that can be acquired during day-to-day activities in the community (not while receiving care in a hospital). Community-acquired pneumonia poses a significant public health burden in terms of mortality, morbidity, and costs. Shorter antibiotic courses for CAP may limit treatment costs and adverse effects, but the optimal duration of antibiotic treatment is uncertain.. To evaluate the efficacy and safety of short-course versus longer-course treatment with the same antibiotic at the same daily dosage for CAP in non-hospitalised adolescents and adults (outpatients). We planned to investigate non-inferiority of short-course versus longer-term course treatment for efficacy outcomes, and superiority of short-course treatment for safety outcomes.. We searched CENTRAL, which contains the Cochrane Acute Respiratory Infections Group Specialised Register, MEDLINE, Embase, five other databases, and three trials registers on 28 September 2017 together with conference proceedings, reference checking, and contact with experts and pharmaceutical companies.. Randomised controlled trials (RCTs) comparing short- and long-courses of the same antibiotic for CAP in adolescent and adult outpatients.. We planned to use standard Cochrane methods.. Our searches identified 5260 records. We did not identify any RCTs that compared short- and longer-courses of the same antibiotic for the treatment of adolescents and adult outpatients with CAP.We excluded two RCTs that compared short courses (five compared to seven days) of the same antibiotic at the same daily dose because they evaluated antibiotics (gemifloxacin and telithromycin) not commonly used in practice for the treatment of CAP. In particular, gemifloxacin is no longer approved for the treatment of mild-to-moderate CAP due to its questionable risk-benefit balance, and reported adverse effects. Moreover, the safety profile of telithromycin is also cause for concern.We found one ongoing study that we will assess for inclusion in future updates of the review.. We found no eligible RCTs that studied a short-course of antibiotic compared to a longer-course (with the same antibiotic at the same daily dosage) for CAP in adolescent and adult outpatients. The effects of antibiotic therapy duration for CAP in adolescent and adult outpatients remains unclear.

Topics: Adolescent; Adult; Anti-Bacterial Agents; Community-Acquired Infections; Drug Administration Schedule; Fluoroquinolones; Gemifloxacin; Humans; Ketolides; Naphthyridines; Outpatients; Pneumonia

Gemifloxacin is a fluoroquinolone antibiotic with broad spectrum of antibacterial activity. The aim of the study was to evaluate the comparative effectiveness and safety of gemifloxacin for the treatment of patients with community-acquired pneumonia (CAP) or acute exacerbation of chronic bronchitis (AECB).. We performed a meta-analysis of randomized controlled trials (RCTs) comparing gemifloxacin with other approved antibiotics. The PubMed, EMBASE, Chinese Biomedical Literature Database and the Cochrane Central Register of Controlled Trials were searched, with no language restrictions.. Ten RCTs, comparing gemifloxacin with other quinolones (in 5 RCTs) and β-lactams and/or macrolides (in 5 RCTs), involving 3940 patients, were included in this meta-analysis. Overall, the treatment success was higher for gemifloxacin when compared with other antibiotics (odds ratio 1.39, 95% confidence interval 1.15 - 1.68 in intention-to-treat patients, and 1.33, 1.02 - 1.73 in clinically evaluable patients). There was no significant difference between the compared antibiotics regarding microbiological success (1.19, 0.84 - 1.68) or all-cause mortality (0.82, 0.41 - 1.63). The total drug related adverse events were similar for gemifloxacin when compared with other quinolones (0.89, 0.56 - 1.41), while lower when compared with β-lactams and/or macrolides (0.71, 0.57 - 0.89). In subgroup analyses, administration of gemifloxacin was associated with fewer cases of diarrhoea and more rashes compared with other antibiotics (0.66, 0.48 - 0.91, and 2.36, 1.18 - 4.74, respectively).. The available evidence suggests that gemifloxacin 320 mg oral daily is equivalent or superior to other approved antibiotics in effectiveness and safety for CAP and AECB. The development of rash represents potential limitation of gemifloxacin.

Topics: Anti-Bacterial Agents; Bronchitis, Chronic; Community-Acquired Infections; Fluoroquinolones; Gemifloxacin; Humans; Naphthyridines; Pneumonia; Quinolones; Randomized Controlled Trials as Topic; Treatment Outcome

Although gemifloxacin has low in vitro activity against Mycobacterium tuberculosis, the effect of gemifloxacin on the delay of tuberculosis (TB) treatment has not been validated in a clinical setting. The study group included patients with culture-confirmed pulmonary TB who initially received gemifloxacin for suspected community-acquired pneumonia (CAP). Two control groups contained patients treated with other fluoroquinolones or nonfluoroquinolone antibiotics. Sixteen cases were treated with gemifloxacin for suspected CAP before TB diagnosis. Sixteen and 32 patients were treated with other fluoroquinolones and nonfluoroquinolones, respectively. The median period from the initiation of antibiotics to the administration of anti-TB medication was nine days in the gemifloxacin group, which was significantly different from the other fluoroquinolones group (35 days). The median times for the nonfluoroquinolone group and the gemifloxacin group were not significantly different. There were no significant differences between the gemifloxacin and other fluoroquinolone group in terms of symptomatic and radiographic improvements. However, the frequency of radiographic improvement in the other fluoroquinolones group tended to be higher than in the gemifloxacin group. Gemifloxacin might be the preferred fluoroquinolone for treating CAP, to alleviate any concerns about delaying TB treatment.

Topics: Adult; Aged; Anti-Bacterial Agents; Case-Control Studies; Fluoroquinolones; Gemifloxacin; Humans; Middle Aged; Naphthyridines; Pneumonia; Radiography; Tuberculosis

We studied the cost-effectiveness of oral gemifloxacin with intravenous ceftriaxone followed by oral cefuroxime with or without a macrolide to treat patients hospitalized with community-acquired pneumonia. Data were prospectively collected as part of a randomized multicenter study. The costs evaluated included antimicrobial acquisition (1st level); plus preparation, dispensing, and administration costs, and treatment of antimicrobial-related adverse events and clinical failures (2nd level); plus per diem costs for hospital stay related to study drug administration (3rd level). At follow-up, clinical success was similar between gemifloxacin (76.9%)- and ceftriaxone (79.1%)-treated patients. The median 1st-level costs for gemifloxacin and ceftriaxone were $136 and $470 (P<0.001), respectively. For the 2nd level, these costs were $158 and $542 (P<0.001), and for the 3rd level, these were $5052 and $5789 (P=0.025), respectively. The median cost per expected success was $6568 for gemifloxacin and $7321 for ceftriaxone (P=0.29). Oral gemifloxacin is clinically effective and has an economic advantage over ceftriaxone, followed by oral cefuroxime with or without a macrolide.

Topics: Adult; Aged; Anti-Bacterial Agents; Ceftriaxone; Cefuroxime; Community-Acquired Infections; Cost-Benefit Analysis; Female; Fluoroquinolones; Gemifloxacin; Humans; Macrolides; Male; Middle Aged; Naphthyridines; Pneumonia

Topics: Community-Acquired Infections; Double-Blind Method; Fluoroquinolones; Gemifloxacin; Humans; Naphthyridines; Pneumonia

Twenty-eight (11.6%) out of 241 Spanish patients enrolled in an international phase III clinical trial of mild to moderate community-acquired pneumonia (CAP) comparing gemifloxacin vs. trovafloxacin were diagnosed of Legionnaires' disease. A definite diagnosis was established by seroconversion in 13 patients of whom only 2 had a positive Legionella urinary antigen. The remaining 15 patients were possible Legionella infections based on a single elevated IgG titer (> or = 1:512). All patients had a radiologically confirmed diagnosis of pneumonia, 5 (19%) patients were older than 65, comorbidity was present in 9 (33%), and 10 (36%) had to be hospitalized. Fifteen patients were treated with oral gemifloxacin (320 mg/day) and 13 with oral trovafloxacin (200 mg/day). Overall, clinical success occurred in 25 (89.3%) patients after 7 days of treatment and only 1 patient needed a 14-day treatment. There were only one adverse event withdrawal and one clinical failure, and no patients died. In light of the favorable clinical outcome, the use of newer fluoroquinolones seems adequate for the treatment of suspected or proven Legionella pneumonia.

Topics: Community-Acquired Infections; Drug Resistance, Microbial; Fluoroquinolones; Gemifloxacin; Humans; Immunoglobulin G; Legionella; Legionellosis; Naphthyridines; Pneumonia; Treatment Outcome

Fluoroquinolone-induced immune-mediated thrombocytopenia is uncommon, and no reports of cross-reactivity among fluoroquinolones exist. Here, we describe a case of ciprofloxacin-induced immune thrombocytopenia with no cross-reactivity with gemifloxacin.. A 77-year-old woman showed profound thrombocytopenia immediately after two ciprofloxacin injections for pneumonia. Platelet counts recovered rapidly after ciprofloxacin discontinuation. She had experienced thrombocytopenia after ciprofloxacin administration 4 years earlier, which was assumed to be ciprofloxacin-induced immune-related. Interestingly, no thrombocytopenia occurred following the subsequent exposure to another fluoroquinolone, gemifloxacin.. No cross-reactivity occurred between ciprofloxacin and gemifloxacin in this fluoroquinolone-induced immune thrombocytopenia case.

Topics: Aged; Anti-Infective Agents; Ciprofloxacin; Female; Fluoroquinolones; Gemifloxacin; Humans; Naphthyridines; Pneumonia; Thrombocytopenia

Although several mathematical models have been proposed to assess the risk:benefit of drugs in one measure, their use in practice has been rather limited. Our objective was to design a simple, easily applicable model. In this respect, measuring the proportion of patients who respond favorably to treatment without being affected by adverse drug reactions (ADR) could be a suitable endpoint. However, remarkably few published clinical trials report the data required to calculate this proportion. As an approach to the problem, we calculated the expected proportion of this type of patients.. Theoretically, responders without ADR may be obtained by multiplying the total number of responders by the total number of subjects that did not suffer ADR, and dividing the product by the total number of subjects studied. When two drugs are studied, the same calculation may be repeated for the second drug. Then, by constructing a 2 x 2 table with the expected frequencies of responders with and without ADR, and non-responders with and without ADR, the odds ratio and relative risk with their confidence intervals may be easily calculated and graphically represented on a logarithmic scale. Such measures represent "net efficacy adjusted for risk" (NEAR). We assayed the model with results extracted from several published clinical trials or meta-analyses. On comparing our results with those originally reported by the authors, marked differences were found in some cases, with ADR arising as a relevant factor to balance the clinical benefit obtained. The particular features of the adverse reaction that must be weighed against benefit is discussed in the paper.. NEAR representing overall risk-benefit may contribute to improving knowledge of drug clinical usefulness. As most published clinical trials tend to overestimate benefits and underestimate toxicity, our measure represents an effort to change this trend.

Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Fluoroquinolones; Gemifloxacin; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Models, Theoretical; Naphthyridines; Pneumonia; Preventive Medicine; Randomized Controlled Trials as Topic; Risk Assessment; Treatment Outcome

Topics: Anti-Infective Agents; Community-Acquired Infections; Double-Blind Method; Fluoroquinolones; Gemifloxacin; Humans; Naphthyridines; Pneumonia; Randomized Controlled Trials as Topic