A Four-Month Gatifloxacin-Containing Regimen for Treating Tuberculosis
Corinne MerleKatherine FieldingOmou Bah SowM. GninafonMame Bocar LoThuli MthiyaneJoseph OdhiamboEvans AmukoyeBoubacar BahFerdinand KassaAlimatou N′DiayeRoxana RustomjeeBouke C. de JongJohn HortonChristian PerronneCharalambos SismanidisOlivier LapujadePiero OlliaroChristian Lienhardt
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Shortening the course of treatment for tuberculosis would be a major improvement for case management and disease control. This phase 3 trial assessed the efficacy and safety of a 4-month gatifloxacin-containing regimen for treating rifampin-sensitive pulmonary tuberculosis.We conducted a noninferiority, randomized, open-label, controlled trial involving patients 18 to 65 years of age with smear-positive, rifampin-sensitive, newly diagnosed pulmonary tuberculosis in five sub-Saharan African countries. A standard 6-month regimen that included ethambutol during the 2-month intensive phase was compared with a 4-month regimen in which gatifloxacin (400 mg per day) was substituted for ethambutol during the intensive phase and was continued, along with rifampin and isoniazid, during the continuation phase. The primary efficacy end point was an unfavorable outcome (treatment failure, recurrence, or death or study dropout during treatment) measured 24 months after the end of treatment, with a noninferiority margin of 6 percentage points, adjusted for country.A total of 1836 patients were assigned to the 4-month regimen (experimental group) or the standard regimen (control group). Baseline characteristics were well balanced between the groups. At 24 months after the end of treatment, the adjusted difference in the risk of an unfavorable outcome (experimental group [21.0%] minus control group [17.2%]) in the modified intention-to-treat population (1356 patients) was 3.5 percentage points (95% confidence interval, -0.7 to 7.7). There was heterogeneity across countries (P=0.02 for interaction, with differences in the rate of an unfavorable outcome ranging from -5.4 percentage points in Guinea to 12.3 percentage points in Senegal) and in baseline cavitary status (P=0.04 for interaction) and body-mass index (P=0.10 for interaction). The standard regimen, as compared with the 4-month regimen, was associated with a higher dropout rate during treatment (5.0% vs. 2.7%) and more treatment failures (2.4% vs. 1.7%) but fewer recurrences (7.1% vs. 14.6%). There was no evidence of increased risks of prolongation of the QT interval or dysglycemia with the 4-month regimen.Noninferiority of the 4-month regimen to the standard regimen with respect to the primary efficacy end point was not shown. (Funded by the Special Program for Research and Training in Tropical Diseases and others; ClinicalTrials.gov number, NCT00216385.).Keywords:
Gatifloxacin
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Pathogenic organism
Shortening the course of treatment for tuberculosis would be a major improvement for case management and disease control. This phase 3 trial assessed the efficacy and safety of a 4-month gatifloxacin-containing regimen for treating rifampin-sensitive pulmonary tuberculosis.We conducted a noninferiority, randomized, open-label, controlled trial involving patients 18 to 65 years of age with smear-positive, rifampin-sensitive, newly diagnosed pulmonary tuberculosis in five sub-Saharan African countries. A standard 6-month regimen that included ethambutol during the 2-month intensive phase was compared with a 4-month regimen in which gatifloxacin (400 mg per day) was substituted for ethambutol during the intensive phase and was continued, along with rifampin and isoniazid, during the continuation phase. The primary efficacy end point was an unfavorable outcome (treatment failure, recurrence, or death or study dropout during treatment) measured 24 months after the end of treatment, with a noninferiority margin of 6 percentage points, adjusted for country.A total of 1836 patients were assigned to the 4-month regimen (experimental group) or the standard regimen (control group). Baseline characteristics were well balanced between the groups. At 24 months after the end of treatment, the adjusted difference in the risk of an unfavorable outcome (experimental group [21.0%] minus control group [17.2%]) in the modified intention-to-treat population (1356 patients) was 3.5 percentage points (95% confidence interval, -0.7 to 7.7). There was heterogeneity across countries (P=0.02 for interaction, with differences in the rate of an unfavorable outcome ranging from -5.4 percentage points in Guinea to 12.3 percentage points in Senegal) and in baseline cavitary status (P=0.04 for interaction) and body-mass index (P=0.10 for interaction). The standard regimen, as compared with the 4-month regimen, was associated with a higher dropout rate during treatment (5.0% vs. 2.7%) and more treatment failures (2.4% vs. 1.7%) but fewer recurrences (7.1% vs. 14.6%). There was no evidence of increased risks of prolongation of the QT interval or dysglycemia with the 4-month regimen.Noninferiority of the 4-month regimen to the standard regimen with respect to the primary efficacy end point was not shown. (Funded by the Special Program for Research and Training in Tropical Diseases and others; ClinicalTrials.gov number, NCT00216385.).
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Acute bacterial conjunctivitis is an acute conjunctivitis that is frequently transmitted in summer and autumn. It is a common and frequently occurring disease in ophthalmology clinic. Gatifloxacin is an effective antibacterial drug. It not only maintains the antibacterial effect of the three generation of fluoroquinolones on Gram-negative bacteria, but also enhances the effectiveness of gatifloxacin, including other Gram-positive bacteria and anaerobes. In this paper, by taking gatifloxacin eye drops as the experimental drug and levofloxacin as the control drug, we conducted a double-blind randomized controlled clinical trial to evaluate the efficacy and safety of gatifloxacin eye drops in the treatment of acute bacterial conjunctivitis. The clinical results showed that the total effective rate of the Gatifloxacin treatment group was 95%. Conclusion shows that gatifloxacin is a safe and effective antibiotic eye drops. It has broad antibacterial spectrum, strong antibacterial activity and effective clinical treatment, and it can effectively treat acute bacterial conjunctivitis.
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Objective: To develop a UV method for the determination of gatifloxacin. Methods: Gatifloxacin was determined at 284 nm and blank supplements had little interference. Results: The calibration curve was linear ( r =0.9999 ) in the range of 3.0 ～ 15.0 μg/mL for gatifloxacin,the mean recovery was 102.5%,with RSD of 1.4 % ( n =9) . Conclusion: The method is sensitive,specific,accurate,simple and was suitable for the determination of gatifloxacin preparations.
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Healthy volunteers received a single dose of gatifloxacin and moxifloxacin (400 mg each), and serum samples were obtained from these volunteers over a 24-h period. Prolonged (> or =12 h) serum bactericidal activity (SBA) was observed for both agents against staphylococcal isolates with minimum inhibitory concentrations (MICs) of gatifloxacin of < or =0.5 mug/mL. In strains with gatifloxacin MICs of 1.0 mug/mL, SBA was observed for < or =6 h, and, for isolates with gatifloxacin MICs of 2.0 mug/mL, little or no SBA was observed for either drug. The relative lack of SBA against less susceptible strains of staphylococci suggests that the current susceptibility breakpoint concentration (MIC, 2.0 mug/mL) for these methoxyfluoroquinolones against Staphylococcus is too high.
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Objective To study the clinical efficacy of gatifloxacin eye drops for bacterial conjunctivitis.Methods A total of 240 cases that diagnosed as bacterial conjunctivitis were randomly divided into test group (gatifloxacin) and control group (floxacin).A random double-blind and paralled study was conducted on 120 cases with gatifloxacin and floxacin eye drops for bacterial conjunctivitis.The drug delivery into conjunctival sac was performed at 7-14 days (one-two drops per time, five times per day).Results Sixty-seven clinical common pathogenic bacteria were separated from the study.The antibacterial activity of gatifloxacin,floxacin, levofloxacin, ciprofloxacin was 98.51%, 85.07%, 95.52%, and 78.79% respectively.The antibacterial activity of gatifloxacin was the highest, and the statistic difference between gatifloxacin and floxacin was found.The effect of gatifloxacin eye drops was not worse than floxacin eye drops.Conclusions The gatifloxacin eye drops has characteristics with broad spectrum, powerfull antibacterial activity.The linical effect of gatifloxacin eye drops is the same with floxacin eye drops.Gatifloxacin eye drops are safe and can be used to treat bacterial conjunctivitis.It has comparatively theropic value of ocular surface disease with Gram-positive bacterial and Gram-negetive bacterial.
Key words:
Gatifloxacin eye drops; Bacterial conjunctivitis; Antibacterial activity
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Pediatric bacterial conjunctivitis is a common, highly contagious infection that requires prompt and effective therapy. In the treatment of bacterial conjunctivitis, gatifloxacin ophthalmic solution 0.3% (Allergan, Inc.) is associated with high clinical cure rates and a low rate of mostly mild adverse effects. In vitro, gatifloxacin ophthalmic solution 0.3% demonstrates bactericidal activity against a broad spectrum of ocular pathogens associated with bacterial conjunctivitis, including many that are resistant to other antibiotics. Gatifloxacin was designed to be less likely than earlier generations of antibiotics to promote antibiotic resistance and is associated with high susceptibility rates. These properties make gatifloxacin an appropriate choice for conditions that require safe and effective treatment in this age of increasing antibiotic resistance.
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OBJECTIVE:To study the characteristics of adverse drug reactions(ADR) induced by gatifloxacin.METHODS:A total of 866 ADR cases induced by gatifloxacin collected in Zhejiang ADR Monitoring Center between Oct.30,2003 and Oct.30,2006 were analyzed with Excel.RESULTS:The common ADR induced by gatifloxacin were lesions of skin and appendages,gastro-intestinal system,systemic and nervous system.Most of the cases were slight in symptoms,but gatifloxacin could also induce severe ADR such as dysglycemia etc that resulting in potential risks to vital human organs.CONCLUSION:ADR monitoring should be emphasized when using gatifloxacin so as to decrease or avoid the occurrence of ADR.
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Aim To study the stability of complexes of gatifloxacin and other five drugs at 25℃.Methods The samples of the complexes were collected in 24h after mixing gatifloxacin and other five drugs at 25℃,the content changes of gatifloxacin and the drugs were determined by means of HPLC.The insolute particles and pH of the samples were also determined by optical resinstance method and pH meter,respectively.Results The complexes (Ⅴ?Ⅵ?Ⅶ?Ⅷ) were no change of colour in 24h.The pH and particles of solutions,varied slightly in acceptable range of pharmacopoeia.The contents of gatifloxacin and three other tested drugs were more than 90% of their initial levels,while the contents of of the two tested drugs were lower than 90% of their initial levels.Conclusion Gatifloxacin and five other drugs were compatible,the contents of gatifloxacin was stable under the experiment condition.
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We read with great interest the paper by Falzon et al. [1], which reported that gatifloxacin and moxifloxacin have been recommended by the World Health Organization (WHO) for both longer and shortened regimens in the treatment of rifampicin-resistant (RR) and multidrug-resistant (MDR) tuberculosis (TB). Gatifloxacin and moxifloxacin belong to the latest generation of fluoroquinolones that have comparable early bactericidal and sterilising activity in the treatment of TB. Gatifloxacin has been used in the treatment of bacterial infections and MDR-TB [2]. Gatifloxacin was also used in a clinical trial (OFLOTUB) comparing a 4-month gatifloxacin-based regimen with the standard 6-month regimen for the treatment of rifampicin-susceptible pulmonary TB [3]. The gatifloxacin-based shortened treatment was highly effective, achieving >84% treatment success among MDR-TB patients in Bangladesh, Cameroon and Niger [2]. Moxifloxacin may not be a valid alternative to gatifloxacin in the treatment of multidrug-resistant tuberculosis
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