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P Zuck

Publications and source records attributed to P Zuck.

At least 19 recordsLinked to original sources

[Efficacy and safety of telithromycin in the treatment of acute exacerbation of chronic obstructive pulmonary disease].

UNLABELLED: The aim of this study was to evaluate the clinical efficacy of telithromycin administered for 5 days at a dosage of 800 mg/day, in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) presenting with at least 2 of Anthonisen's criteria including the increase of purulence. METHODOLOGY: During this multicenter (211 private lung specialists), prospective, non-comparative, open-labeled French study, 365 patients were included between April 2002 and March 2003. Clinical efficacy was assessed on D12-D19 by the rate of clinical success as defined by recovery or clinical improvement (main endpoint) according to the number of exacerbation episodes during the previous year. RESULTS: On D12-D19 clinical success rate in the per protocol global population was 88.0% and respectively 87.9% in patients with or=4 episodes in the previous year. These success rates were similar to those in the intent-to-treat population. Safety, assessed on 359 patients, was satisfactory, with mainly digestive disorders related to the treatment in 3.9% of the patients. No treatment-related serious adverse events were observed. CONCLUSION: This study, conducted among private practitioners in France according to COPD classification as defined by official recommendations, validates the results obtained in previous studies. Our results confirm the place attributed to telithromycin in the treatment of patients presenting with AECOPD without chronic respiratory failure, according to ongoing official recommendations.

Acute Disease↗

[Efficacy and safety of extended-release clarithromycin (5-day short-course) vs telithromycin, in acute bacterial exacerbation of chronic bronchitis].

BACKGROUND: The extended-release formulation of clarithromycin (CLA-ER) allows using this macrolide as a single daily dose. The purpose of this study was to evaluate the efficacy and safety of the CLA-ER formulation (500 mgx2) vs telithromycin (TELI) (400 mgx2) as a short course 5-day treatment, once a day, in patients with AECB. METHOD: This randomized double-blind study was conducted in patients with AECB without severe airflow limitation (FEV1>35%), with sputum purulence (mandatory criterion), and with either increased sputum volume or increased dyspnea, or both (Anthonisen criteria I or II). RESULTS: Three hundred sixty-two patients were assessed (62.6 years of age+/-12.9, men: 58.8%) positive culture on inclusion for 53.8%, with Haemophilus influenzae (N=57), Moraxella catarrhalis (N=42), and Streptococcus pneumoniae (N=41). In the per protocol population, the clinical success rate at day 8 was 97% (161/166) vs 97% (146/151), 97.5% CI=[-4.12 -4.71], the clinical cure rate at day 30 was 78% (129/166) versus 77% (116/151), P=0.85, and mean time without recurrence was 62 days versus 61 days (P=0.51), in CLA-ER and TELI groups, respectively. Fourteen patients in the CLA-ER group (8.2%) and 20 patients in the TELI group (12.4%) experienced at least one treatment-related adverse event (P=0.21), upon which gastrointestinal events were the most commonly reported treatment-related ones. CONCLUSION: CLA-ER (1000 mg once a day) for 5 days is at least as effective as telithromycin in the treatment of AECB without severe airflow limitation and is well tolerated.

Aged↗

Moxifloxacin monotherapy compared to amoxicillin-clavulanate plus roxithromycin for nonsevere community-acquired pneumonia in adults with risk factors.

The objective of this study was to assess the efficacy and safety of moxifloxacin versus amoxicillin-clavulanate plus roxithromycin (comparator) in adult community-acquired pneumonia (CAP) patients with risk factors. In this comparative, randomized, multicenter, open-label study, patients hospitalized for CAP received a 10-day oral treatment with either moxifloxacin (400 mg o.d.) or amoxicillin-clavulanate (1,000/125 mg t.i.d.) plus roxithromycin (150 mg b.i.d.). Clinical and bacteriological outcomes were assessed during test of cure and follow-up visits (5-7 days and 21-28 days after the end of treatment, respectively). Of 349 randomized patients, 346 were included in the intent-to-treat analysis and 289 in the per-protocol analysis. Their baseline characteristics were comparable. The most frequent risk factors for mortality were age >65 years (50.0%), alcoholism (23.1%), and comorbidities (50.6%); chronic obstructive pulmonary disease (COPD) (25.4%) and diabetes mellitus (13.6%) were the most common associated comorbidities. A causative pathogen was documented in 66 of 346 (19.1%) of the patients (including 21 with positive blood cultures). Respective per-protocol clinical success rates at test-of-cure (primary efficacy endpoint) for moxifloxacin and comparator were 131 of 151 (86.8%) and 120 of 138 (87.0%), with a 95% confidence interval (CI) of -8.0-7.6 for the difference. Bacteriological success rates (eradication) were 23 of 30 (76.7%) and 23 of 31 (74.2%); rates for patients with positive blood cultures were 10 of 14 and 4 of 6. Persistent clinical success rates at follow-up were 118 of 120 (98.3%) and 102 of 106 (96.2%), with a 95%CI of -2.2-6.4 for the difference. The intent-to-treat analysis confirmed these results. Adverse events associated with moxifloxacin and the comparator drug were reported for 42 of 171 (24.6%) and 50 of 175 (28.6%) of the patients, respectively, and comprised predominantly digestive disorders, which occurred in 9.4% and 21.1%. On the basis of these results, once-daily oral moxifloxacin alone is as effective as amoxicillin-clavulanate plus roxithromycin for the treatment of CAP in patients with risk factors.

Adult↗

[Hemothorax in a 78-year-old woman].

We report an atypical presentation of hemothorax. Tamponade and subacute dyspnea occurred secondary to a wound of the right atrium caused by a pacemaker electrode in 78-year-old woman on oral anticoagulants for complete arrhythmia due to atrial fibrillation. This case illustrate an unusual pathophysiological mechanism of hemothorax.

Aged↗

[Efficacy of levofloxacin in the treatment of acute exacerbation of chronic bronchitis in patients with risk factors].

Studies of acute exacerbations of chronic bronchitis (EXCB) included in the approval documents of levofloxacin (LVF) were reviewed in light of the good conditions of use defined by the French marketing approval and the AFSSAPS recommendations. The approval documents included two American studies comparing LVF 500 mg/d for 5-7 days with cefaclor 750 mg/d for 7-10 days or cefuroxime axetil (CXM) 500 mg/d for 7-10 days. A new descriptive analysis of efficacy was performed on a population meeting the recommendation criteria for antibiotic treatment in patients with clinical signs of obstruction. This analysis was stratified by number of risk factors (RF) for the following aggravating conditions: age above 65 years, diabetes or corticosteroid therapy. In the American studies, clinical efficacy, measured by rate of success in the total population, in the EXCB population requiring antibiotic therapy with or without risk factors, and in the EXCB population with at least one and at least two of the above-cited risk factors was 93.4% (351/376), 93.0% (268/288), 90.4% (122/135) and 94.4% (34/36) respectively with LVF and 92.2% (354/384), 92.5% (273/295), 87.7% (128/146) and 79.3% (23/29) respectively with the compared drugs. In the European study, the clinical efficacy in the total population, in the EXCB population requiring antibiotic therapy with or without risk factors, and in the EXCB population with at least one and at least two of the above-cited risk factors was 81.9% (195/238), 82.4% (182/221), 78.9% (112/142) and 75.0% (27/36) respectively with LVF and 72.5% (166/229), 74.0% (154/208), 73.1% (95/130) and 58.3% (21/36) respectively with the compared drugs. The efficacy of levofloxacin is thus confirmed for EXCB with signs of obstruction. When stratifying for RF, the efficacy of LVG persists with increasing numbers of RF, a result not observed with the compared drugs.

Acute Disease↗

Randomized controlled trial of sequential intravenous (i.v.) and oral moxifloxacin compared with sequential i.v. and oral co-amoxiclav with or without clarithromycin in patients with community-acquired pneumonia requiring initial parenteral treatment.

The objective of the present trial was to compare the efficacy, safety, and tolerability of moxifloxacin (400 mg) given intravenously (i.v.) once daily followed by oral moxifloxacin (400 mg) for 7 to 14 days with the efficacy, safety, and tolerability of co-amoxiclav (1.2 g) administered by i.v. infusion three times a day followed by oral co-amoxiclav (625 mg) three times a day, with or without clarithromycin (500 mg) twice daily (i.v. or orally), for 7 to 14 days in adult patients with community-acquired pneumonia requiring initial parenteral therapy. A total of 628 patients were enrolled and assessed by evaluation of their clinical and bacteriological responses 5 to 7 days and 21 to 28 days after administration of the last dose of study medication. Although the trial was designed, on the basis of predefined outcomes, to demonstrate the equivalence of the two regimens, the results showed statistically significant higher clinical success rates (for moxifloxacin, 93.4%, and for comparator regimen, 85.4%; difference [Delta], 8.05%; 95% confidence interval [CI], 2.91 to 13.19%; P = 0.004) and bacteriological success rates (for moxifloxacin, 93.7%, and for comparator regimen, 81.7%; Delta, 12.06%; 95% CI, 1.21 to 22.91%) for patients treated with moxifloxacin. This superiority was seen irrespective of the severity of the pneumonia and whether or not the combination therapy included a macrolide. The time to resolution of fever was also statistically significantly faster for patients who received moxifloxacin (median time, 2 versus 3 days), and the duration of hospital admission was approximately 1 day less for patients who received moxifloxacin. The treatment was converted to oral therapy immediately after the initial mandatory 3-day period of i.v. administration for a larger proportion of patients in the moxifloxacin group than patients in the comparator group (151 [50.2%] versus 57 [17.8%] patients). There were fewer deaths (9 [3.0%] versus 17 [5.3%]) and fewer serious adverse events (38 [12.6%] versus 53 [16.5%]) in the moxifloxacin group than in the comparator group. The rates of drug-related adverse events were comparable in both groups (38.9% in each treatment group). The overall incidence of laboratory abnormalities was similar in both groups. Thus, it is concluded that monotherapy with moxifloxacin is superior to that with a standard combination regimen of a beta-lactam and a beta-lactamase inhibitor, co-amoxiclav, with or without a macrolide, clarithromycin, in the treatment of patients with community-acquired pneumonia admitted to a hospital.

Administration, Oral↗

Ligand-receptor binding measured by laser-scanning imaging.

This report describes the integration of laser-scanning fluorometric cytometry and nonseparation ligand-binding techniques to provide new assay methods adaptable to miniaturization and high-throughput screening. Receptor-bound, cyanine dye-labeled ligands, [Cy]ligands, were discriminated from those free in solution by measuring the accumulated fluorescence associated with a receptor-containing particle. To illustrate the various binding formats accommodated by this technique, saturation- and competition-binding analyses were performed with [Cy]ligands and their cognate receptors expressed in CHO cells or as fusion proteins coated on polystyrene microspheres. We have successfully applied this technique to the analysis of G protein-coupled receptors, cytokine receptors, and SH2 domains. Multiparameter readouts from ligands labeled separately with Cy5 and Cy5.5 demonstrate the simultaneous analysis of two target receptors in a single well. In addition, laser-scanning cytometry has been used to assay enzymes such as phosphatases and in the development of single-step fluorescent immunoassays.

Adaptor Proteins, Signal Transducing↗

Randomized, double-blind study of short-course (5 day) grepafloxacin versus 10 day clarithromycin in patients with acute bacterial exacerbations of chronic bronchitis.

The efficacy and safety of grepafloxacin were compared with clarithromycin in a randomized, double-blind, multicentre clinical trial of 805 patients with acute bacterial exacerbations of chronic bronchitis (ABECB). Patients were randomized to receive grepafloxacin 400 mg od for either 5 (n = 273) or 10 days (n = 268) or clarithromycin 250 mg bd for 10 days (n = 261). Patients were assessed pre-treatment, 3-5 days during treatment, 1-3 days post-treatment and at follow-up (21-28 days post-treatment). The clinical success rates for the evaluable patients were 91% in the 5 day grepafloxacin group, 95% in the 10 day grepafloxacin group and 86% in the clarithromycin group. At follow-up, respective rates were 72%, 81% and 73%. A total of 513 pathogens were isolated from the pre-treatment sputum specimens of 400 (49%) patients. The primary pathogens were Haemophilus influenzae (36% of isolates), Haemophilus parainfluenzae (27%), Moraxella catarrhalis (12%), Streptococcus pneumoniae (11%) and Staphylococcus aureus (3%). Pathogens were eradicated or presumed eradicated at post-treatment in 85%, 91% and 58% of evaluable patients treated with grepafloxacin for 5 days, grepafloxacin 10 days and clarithromycin 10 days, respectively. The eradication rates in both grepafloxacin groups were significantly greater than the clarithromycin group (P<0.001). All treatments were well tolerated and incidence of drug-related adverse events in each group was comparable. This study demonstrates that both a 5 and a 10 day regimen of grepafloxacin 400 mg od are as clinically and bacteriologically effective as in the treatment of ABECB clarithromycin 250 mg bd. for 10 days.

Acute Disease↗

Bacteriological eradication of Streptococcus pneumoniae from patients with acute exacerbations of chronic bronchitis: cefuroxime axetil versus cefixime.

The bacteriological eradication rates of Streptococcus pneumoniae from sputum of patients experiencing acute exacerbations of chronic bronchitis (WHO definition) have been compared following therapy with either cefuroxime axetil 250 mg b.d. or cefixime 200 mg b.d. All patients were hospitalised for an acute exacerbation of chronic bronchitis. The study design was a multicentre, double-blind, randomised, parallel group with patients giving written informed consent initially. Patients were recruited to the study if they met the WHO definition of chronic bronchitis, were aged 30-75 years and had a high probability of S. pneumoniae infection based on initial sputum Gram stain. All S. pneumoniae isolates were serotyped and susceptibility tested at the National Reference Centre, Paris. S. pneumoniae was eradicated more rapidly following cefuroxime axetil administration than after cefixime and this difference was statistically significant (p = 0.002) at 2-4 days post-treatment. Clinical endpoints showed a similar trend--94% response to cefuroxime axetil compared with 71% response to cefixime (RR 6.39:1). Cefuroxime eradicated S. pneumoniae significantly more rapidly than cefixime and patients in the cefuroxime axetil arm had favourable clinical criteria. The data suggest that focused antibacterial studies may be helpful in evaluating antibiotics in acute exacerbation of chronic bronchitis.

Adult↗

A double-blind randomized trial comparing the efficacy and safety of a 5-day course of cefotiam hexetil with that of a 10-day course of penicillin V in adult patients with pharyngitis caused by group A beta-haemolytic streptococci.

A 10-day course of penicillin is the antibiotic regimen currently recommended by the American Heart Association (AHA) as treatment for patients with tonsillitis caused by group A beta-haemolytic streptococci (GABHS), with the aim of preventing both the suppurative and non-suppurative complications of this infection. This prospective, multicentre, randomized, double-blind, double-dummy clinical trial was undertaken in order to compare the efficacy of, tolerability of and compliance with a 5-day course of cefotiam hexetil (CTM) 200 mg bd with that of a 10-day course of penicillin V (PEV) 1 megaunit (600 mg) tds, to investigate the significance of recovering GABHS during or after treatment and to evaluate the potential economic advantages of short-term regimens. Two hundred and fifty ambulatory adult patients with a presumptive diagnosis (based on a positive rapid antigen detection test) of GABHS tonsillitis were recruited in 60 centres; the diagnosis was subsequently confirmed by a positive culture of a throat swab. At the time of entry into the trial there was no statistically significant difference between the groups in terms of clinical symptoms. In an intention-to-treat analysis, both the clinical and bacteriological response rates at days 10 and 30 were comparable for each group i.e. 106 of 119 (89.1%) patients and 90 of 109 (82.6%) patients respectively in the CTM group and 103 of 117 (88.0%) patients and 92 of 107 (86.0%) patients respectively in the PEV group. The times until defervescence and resolution of symptoms were also similar. Of the 115 patients in each group who were assessed at day 90, there were three clinical relapses in the CTM group and seven in the PEV group. No non-suppurative complications of GABHS infection were detected. Tolerance was significantly better in the CTM group than in the PEV group, 14 of 119 (11.8%) patients and 26 of 117 (22.2%) patients in the former and latter groups respectively reporting adverse events. In three cases in each group treatment was discontinued prematurely because of adverse events; none of these in the CTM group was serious but one patient in the PEV group experienced a severe allergic reaction. Compliance in both groups was good during the first 5 days of therapy but, by the end of each course, 93.6% of patients in the CTM group had completed treatment, compared with 73.0% in the PEV group.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

Piroxicam induced pulmonary infiltrates and eosinophilia.

We describe 2 patients who developed pulmonary infiltrates while being treated with piroxicam. There was no satisfactory explanation other than drug induced lung disease for their illness. They had no exposure to pneumotoxic drugs or aerocontaminants. Microorganisms were not cultured in sputum or bronchoaveolar lavage. There was no underlying illness with possible lung involvement. Pulmonary infiltrates developed during piroxicam therapy, disappeared after drug withdrawal and recurred following rechallenge.

Aged↗

[Monotherapy using amoxicillin/clavulanic acid as treatment of first choice in community-acquired lung abscess. Apropos of 57 cases].

In a multicentre open prospective trial the effectiveness of AM-CA as first-line treatment of community-acquired lung abscess was evaluated in immunocompetent adult patients. AM-CA was administered intravenously in doses of 4 g/day for at least 7 days, then orally in doses of 2 g/day for at least 14 days. Radio-clinical and laboratory evaluations were made during treatment, and 30 and 60 days after it was discontinued. The results of this trial concerned 57 patients (48 men, 9 women; mean age 52 years). The facilitating factors were those usually found in lung abscess. Twenty-seven patients had previously received an antibiotic treatment which had failed. The clinical picture, built up gradually in 42/37 patients, consisted of infectious syndrome (52 cases), altered general condition (39 cases), purulent expectoration (47 cases), sometimes foetid (10 cases), and thoracic clinical abnormalities (57 cases. X-ray films of the chest showed round abscess images (44 cases) or looked like necrotizing pneumonia (13 cases) with pleural reaction (8 cases). Protecting bacteriological sampling by BFW brushing and transtracheal or transparietal sample collecting was performed in 41 of the 57 patients. The pathogens, isolated in 31 cases, were: S. pneumoniae 5; Streptococcus spp. 12; Staph. aureus 4; H. influenzae 7; Enterobacteriaceae 6; anaerobes 7. These organisms were associated in 8 cases. With the exception of Enterobacter cloacae, all were sensitive to AM-CA in-vitro. The outcome was satisfactory in 52 patients.

Adolescent↗

Efficacy and tolerance of cefpodoxime proxetil compared with co-amoxiclav in the treatment of exacerbations of chronic bronchitis.

This European, multicentre trial evaluated the efficacy and tolerance of cefpodoxime proxetil in comparison with co-amoxiclav (amoxycillin plus clavulanic acid) in the treatment of acute exacerbations of chronic bronchitis. The study design was double-blind and double-placebo controlled. Doses of either 200 mg bd of cefpodoxime proxetil or 500 mg/125 mg tds amoxycillin plus clavulanic acid were given orally for 9.6 +/- 1.8 days. Two hundred and fifty-one patients were enrolled in 27 centres in West Germany, France, and Italy. The overall clinical efficacy was 97.2% in the cefpodoxime proxetil group compared with 94.7% in the co-amoxiclav group. Fifty-eight adverse events, mainly gastrointestinal, occurred in 42 patients with no significant difference between the groups. A significant difference in the number of resistant pathogens on pre-treatment culture to the advantage of cefpodoxime was noted. In our experience, both drugs were of similar value in the treatment of respiratory tract infections. Thus, cefpodoxime proxetil should be an effective antibiotic for the treatment of acute exacerbations of chronic bronchitis.

Adult↗

Efficacy and tolerance of cefpodoxime proxetil compared with ceftriaxone in vulnerable patients with bronchopneumonia.

This multicentre, randomized study compared the efficacy and tolerance of cefpodoxime proxetil and ceftriaxone in vulnerable patients with bronchopneumonia. Patients received cefpodoxime proxetil 200 mg bd orally or ceftriaxone 1 g daily im for a ten-day period. They were evaluated at days 10 and 30. Ninety-six patients were evaluated for tolerance, 85 for clinical efficacy and 65 for bacteriological efficacy. At entry all patients had radiographic evidence of pneumonia and 74% of bacteriological samples were positive. The percentage of overall success (cured or improved) was 97.7% (43/44) in the cefpodoxime proxetil group and 95.1% (39/41) in the ceftriaxone group. The bacteriological efficacy was 94.3% in the cefpodoxime proxetil group and 97.4% in the ceftriaxone group. Clinical tolerance was satisfactory in both groups. In this study, the clinical and bacteriological results obtained with cefpodoxime proxetil were comparable with those obtained with ceftriaxone in the treatment of community-acquired bronchopneumonia in patients with additional risk factors.

Adult↗

["Plastic lung". Broncho-pulmonary pathology related to plastics (author's transl)].

Plastics can induce three main groups of respiratory accidents.--Acute and subacute intoxications related to the inhalation of volatil substances from decomposing plastics (mostly during burning and pyrolysis) or on the contrary during synthesis. They are accidental chemical broncho-pneumopathies (acute tracheo-bronchitis and pulmonary edema).--Chronic broncho-pneumopathies following repeated inhalation of dusts or suspension of plastics: pneumoconioses and thesaurismoses leading to pulmonary fibrosis.--Broncho-pneumopathies related to the irritant and sensitizing action of some components of plastics: professional asthma and sensitization pneumopathies. Diagnosis of such diseases therefore imposes a careful study of working conditions. Proof rests on two arguments:--curing by risk eviction;--analysis of the products in order to reveal their toxicity.

Humans↗