[Telemedicine and lung transplanted patients: A feasibility study]. / Télé-suivi des patients transplantés pulmonaires : étude de faisabilité

BACKGROUND: Lung transplant patients are characterized by a high use of healthcare resources and an elevated rate of hospitalization. In lung transplant recipients, spirometry home monitoring has been advocated for the early detection of acute infection and rejection of the allograft. We will test a new system that allows regular monitoring of the patient's pulmonary status at home after discharge from hospital. METHODS: This study will be prospective and in addition to usual healthcare. The main aim of this feasibility study will be to evaluate the compliance of patients in performing three spirometric measurements per week. Patients will have received a lung transplant more than three months prior to entering the study. The home equipment will comprise a data transmitting box (Twitoo(®)) and a spirometer. A decrease of 10% from baseline in one or more parameters will generate an alarm, which will lead to the transplant physician calling the patient and possibly inviting him to the hospital. EXPECTED RESULTS: The feasibility will be considered as acceptable for an average compliance of 70%. The coefficient of variation and the number of spiro-measurements will be adjusted according to the results obtained.

[Education of patients with sleep apnea syndrome: Feasibility of a phone coaching procedure. Phone-coaching and SAS]. / Faisabilité du "coaching" téléphonique dans l'appareillage du syndrome d'apnée du sommeil. Coaching téléphonique et SAS.

INTRODUCTION: The most commonly used treatment for obstructive sleep apnea syndrome (OSA) is the application of continuous positive airway pressure (CPAP) during sleep. However compliance with this treatment is frequently below 70%. METHODS: The main aim of this study was to evaluate the feasibility of an educational intervention (EI) delivered in phone calls made to OSA patients (n=66) treated with CPAP by a home care provider (SADIR). The educational intervention consisted of five sessions of telephone based counseling intervention by appropriately trained staff delivered on day 3, 10, 30, 60 and 90 after initiation of treatment. Secondary objectives were to compare, using a case-control design, CPAP compliance of OSA patients (n=133) with or without EI. RESULTS: Ninety-eight percent of patients accepted the intervention to participate in the study. Fifty-seven patients (86%) received the full intervention program and 44 patients (66%) strictly respected the pre-defined timings per protocol. A higher adherence to CPAP at six months was observed in the EI group compared to patient without EI (94% versus 81%) (P<0.05). CPAP compliance at three months was 54minutes higher in the EI group compared to the control group (4h39±2h17 and 3h45±2h45 respectively) but this difference was not statistically significant. CONCLUSION: An educational intervention dispensed by phone is applicable and would have an impact on CPAP compliance. Its efficacy on long-term compliance has to be confirmed in a larger group using a randomized procedure.

[Home telemonitoring of CPAP: a feasibility study]. / La télé-observance à domicile de la pression positive continue: étude de faisabilité.

BACKGROUND: The most commonly used treatment for the sleep apnoea syndrome (SAS) is the application of constant positive airway pressure (CPAP) during sleep. Compliance is an essential element in the efficiency of CPAP. This is dependent on the quality of the management of care and on the education of the patients. With the emergence of telemedicine, telemonitoring of CPAP has been developed in France. METHODS: This study will be observational and multicentered. The main aim is to evaluate the feasibility of CPAP telemonitoring in SAS patients (n=90). During the installation of the equipment, the patients will be instructed how to connect the CPAP Secure Digital card to a data transmitting box every week for two months. The actual number and frequency of remote-monitoring box connections will be recorded. The data transmission will be made to the study coordinator, the home care provider SADIR, by the way of a telemedicine platform, located in France. EXPECTED RESULTS: This study will allow measurement of the adherence of the patients to their CPAP treatment by telemonitoring using this new tool of data transmission and the impact of this on CPAP compliance.

[Routine use of extended-release clarithromycin tablets for short-course treatment of acute exacerbations of non-severe COPD]. / Utilisation de la clarithromycine à libération modifiée en traitement court des exacerbations aiguës d'une BPCO peu grave en pratique médicale courante.

OBJECTIVE: This study was designed to confirm, in routine clinical practice conditions, the success rates and safety of extended-release clarithromycin tablets in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD), according to the usual empirical criteria in routine clinical practice. PATIENTS AND METHODS: An open-label, pharmacoepidemiological, clinical study in community practice was performed with 180 practitioners. The bacterial origin was suspected when sputum was obviously purulent. RESULTS: Seven hundred and nineteen adult patients with acute exacerbation of mild or moderately severe COPD were included. A favorable clinical course of the exacerbation was observed in 92.5% of cases, with resolution of frankly purulent sputum in 99% of cases, associated with good tolerance. CONCLUSION: These results confirm the value of extended-release clarithromycin tablets as first-line treatment for presumed bacterial exacerbation of mild or moderately severe, stable COPD according to the Société de pathologie infectieuse de langue française consensus.

[Profile and management of patients consulting for a non severe exacerbation of chronic obstructive pulmonary disease (Pragma survey)]. / Profil et prise en charge de patients venant consulter pour une exacerbation de bronchopneumopathie chronique obstructive non sévère (enquête Pragma) Etude observationnelle sur 4763 patients.

OBJECTIVES: To evaluate, in patients with chronic obstructive pulmonary disease (COPD), stage 0 or 1, the percentage of patients who had spirometry, and to study their sociodemographic, clinical and epidemiological characteristics. PATIENTS AND METHODS: An epidemiological survey was conducted with 2389 general practitioners concerning 4769 patients with early COPD, consulting for the first time for exacerbation of COPD, presumed to be bacterial. RESULTS: Spirometry under stable conditions was performed in only 30% of patients. When the physician does not have access to this examination to guide antibiotic prescription for an exacerbation presumed to be bacterial, recent guidelines have established a correlation between dyspnoea and the degree of severity of COPD (GOLD classification). This correlation was not confirmed by the present study: 34% of patients with stage 0 or 1 COPD complained of dyspnoea and 52% of patients with stage 2 or 3 COPD did not complain of dyspnoea. The main criterion in favour of a bacterial cause of exacerbation, frank purulent sputum, observed in one out of three patients, did not influence the decision to prescribe antibiotics, given to 98% of patients. Therapy used bronchodilators (73%), even in patients with no signs of obstruction, and inhaled steroids (72%), although, according to guidelines, they are only indicated in the most serious forms (stage 3). This survey illustrates the effort needed to ensure better concordance between guidelines and practice, by taking into account the difficulties encountered by practitioners.

[Oxidatif-stress and COPD. Role of infection. Prevention]. / Stress oxydatif et BPCO. Rôle des infections. Prévention.

For the next decade, COPD will become the third cause of mortality in the world. COPD is mainly due to cigarette smoking and presents different levels of severity according to people, probably linked to environmental and genetic factors, which are not well documented. Recent publications pointed out bacterial bronchial colonization and exacerbations of infectious origin as worsening factors through a pro-inflammatory effect and oxidative stress. This should lead to a comprehensive review of anti-infectious prevention tools and to discuss the role of prophylactic antibiotherapy and antioxidants.

Liens entre résistance et échec dans les infections respiratoires communautaires.

Resistance is one of failure's reasons. We tried, through clinical experience, to approach the magnitude and nature of the links, between phenotypically defined acquired resistance and clinical failure, in community acquired respiratory infections. An efficient resistance mecanism, able to suppress antibiotic action, is clearely associated to a risk of clinical failure (e.g. betalactamase secretion, target modification using methilation for macrolides, target mutation for fluoroquinoles). Resistance mecanism due to reduction of target affinity (pneumococcus and betalactams) progressively decreasing beta lactam activity depending on its expression, is at present time, not clearely associeted with clinical failure. Critical concentration, defining phenotypical resistance, is predictive of failure if it identifies a bacterial population owning an efficient resistance mecanism. It will not be predictive of failure if that concentration do not detect the resistance mecanism (e.g. parC mutation and levofloxacin) or if the link between antibiotic and resistant bacteria is not binary but depends also on pharmacokinetic parameters (pneumococcus and betalactam). Using resistance as a parametre for antibiotic choice, must integrate several elements: presence or not of a resistance mecanism, type and efficiency of the mecanism, links with clinical failure and antibiotic concentration, type and site of infection. Critical concentration is not allways the magic number that predict failure or success.

[Link between resistance and failure in community-acquired respiratory infections]. / Liens entre résistance et echec dans les infections respiratoires communautaires.

Resistance is one of failure's reasons. We tried, through clinical experience, to approach the magnitude and nature of the links, between phenotypically defined acquired resistance and clinical failure, in community acquired respiratory infections. An efficient resistance mecanism, able to suppress antibiotic action, is clearely associated to a risk of clinical failure (e.g. betalactamase secretion, target modification using methilation for macrolides, target mutation for fluoroquinoles). Resistance mecanism due to reduction of target affinity (pneumococcus and betalactams) progressively decreasing beta lactam activity depending on its expression, is at present time, not clearely associeted with clinical failure. Critical concentration, defining phenotypical resistance, is predictive of failure if it identifies a bacterial population owning an efficient resistance mecanism. It will not be predictive of failure if that concentration do not detect the resistance mecanism (e.g. parC mutation and levofloxacin) or if the link between antibiotic and resistant bacteria is not binary but depends also on pharmacokinetic parameters (pneumococcus and betalactam). Using resistance as a parametre for antibiotic choice, must integrate several elements: presence or not of a resistance mecanism, type and efficiency of the mecanism, links with clinical failure and antibiotic concentration, type and site of infection. Critical concentration is not allways the magic number that predict failure or success.

[Efficacy and safety of extended-release clarithromycin (5-day short-course) vs telithromycin, in acute bacterial exacerbation of chronic bronchitis]. / Efficacité et tolérance de la clarithromycine, forme à libération modifiée en traitement court de cinq jours dans les exacerbations aiguës de bronchite chronique, comparativement à la télithromycine.

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.

[Oxidative stress in bronchopulmonary disease: contribution of N-acetylcysteine (NAC)]. / Le stress oxydatif en pathologie broncho-pulmonaire: apport de la N-acétyl-cystéine (NAC).

Oxidative stress is a frequent mechanism involved in the pathogenesis of bronchopulmonary disease. The cause can be exogenous, in particular related to to atmospheric pollution and tobacco smoke, or endogenous, related to mobilization of inflammatory cells (macrophages and polymorphonuclear neutrophils). In this general review, we present work demonstrating this oxidative stress and activation of inflammatory cells. We discuss the effect of oxidative stress on the bronchial tree and the need to maintain an adequate balance between oxidants and anti-oxidants. This reviews focuses on experimental studies proving the anti-oxidant effect of NAC on glutathione synthesis and on different pharmacological models. We then discuss human trials, initially experimental then in different bronchopulmonary pathologies related to oxidative stress. Acetaminophen intoxication and pulmonary fibrosis are models for use of NAC. Recent work on COPD appears to show a decrease in exacerbations, improvement in symptoms and quality-of-life, and perhaps a reduction in the alteration of ventilatory function.

Gemifloxacin once daily for 7 days compared to amoxicillin/clavulanic acid thrice daily for 10 days for the treatment of community-acquired pneumonia of suspected pneumococcal origin.

CONTEXT: Community-acquired pneumonia (CAP) is common among adults and contributes considerably to morbidity and mortality. OBJECTIVE: To compare the safety and efficacy of gemifloxacin to high-dose amoxicillin/clavulanate for the treatment of CAP of suspected pneumococcal origin. DESIGN: Randomized, multicentre, double-blind, double-dummy, parallel group Phase III study. SETTING AND PARTICIPANTS: From September 1998 to July 1999, 324 patients with CAP were randomized at 102 centers in France, Poland and the Republic of South Africa. INTERVENTION: Patients were double-blind randomized to receive either oral gemifloxacin 320 mg once daily for 7 days or oral amoxicillin/clavulanate 1 g/125 mg three times daily for 10 days. MAIN OUTCOME MEASURES: The main outcome measures were clinical, bacteriological, and radiological responses at the end of therapy (day 12-14) and follow-up (day 24-30) visits. RESULTS: In 228 PP patients, clinical resolution at follow-up was 88.7% for 7-day gemifloxacin and 87.6% for 10-day amoxicillin/clavulanate [95% CI, -7.3, 9.5]. In 249 PP patients, clinical resolution at end of therapy was 95.3% for 7-day gemifloxacin vs. 90.1% for 10-day amoxicillin/clavulanate [95% CI, -1.2, 11.7]. Bacteriologic response rates for the PP patients at end of therapy were 96.3% for 7-day gemifloxacin and 91.8% for the amoxicillin/clavulanate group [95% CI, -4.7, 13.6]. Bacteriologic response rates at follow-up were 87.2% for 7-day gemifloxacin and 89.1% for the amoxicillin/clavulanate group [95% CI, -15.0, 11.2]. Specifically gemifloxacin eradicated 95.7% of Streptococcus pneumoniae including penicillin and macrolide resistant strains. Radiological response rates for the PP patients at end of therapy were 89.1% for 7-day gemifloxacin and 87.6% for the amoxicillin/clavulanate group. The most frequently reported drug-related events were in the gemifloxacin group, diarrhea (6.0%) and rash (3.0%) and in the amoxicillin/clavulanate group, diarrhea (11.1%) and fungal infection, vaginitis and vomiting (each 2.0%). Overall there were statistically fewer withdrawals due to lack of therapeutic effect in the gemifloxacin group compared with the amoxicillin/clavulanate cohort, (95% CI, -8.8;0.6; P = 0.03). CONCLUSION: Gemifloxacin 320 mg once daily for 7 days was found to be clinically, bacteriologically, and radiologically as effective as 10 days of amoxicillin/clavulanate 1 g/125 mg three times daily for the treatment of suspected pneumococcal CAP.

[Treatment of exacerbations of chronic obstructive pulmonary disease with pristinamycin]. / Traitement des exacerbations de broncho-pneumopathie chronique obstructive (BPCO) par la pristinamycine.

BACKGROUND: Pristinamycin is a bactericidal antibiotic whose spectrum covers the main respiratory pathogens including S. pneumoniae poorly sensitive to penicillin. It has not yet been evaluated in short course treatment of acute exacerbations of chronic obstructive bronchitis (AECB). METHODS: 476 patients suffering from an AECB were randomised to either a short course of pristinamycin, 3 G daily for 4 days, or conventional treatment with co-amoxiclav (AAC) 2G daily for 8 days. The duration of follow-up was 6 months. RESULTS: The clinical success rate at 21 days was the same in both groups at 87.2% and 87.9%, CI95% [-7.0%, 6.0%], in the protocol population (FEV1<80%). Among the 120 patients in whom a bacterial pathogen was isolated at the time of inclusion a satisfactory bacteriological response was obtained in 84.6% of the PRI patients against 78.2% of the AAC patients. The time to relapse was comparable with a relapse rate of 25% reached in 128 days in the PRI group and 125 days in the AAC group. Treatment related side effects occurred in 9.2% of the PRI group and in 10.6% of the AAC group. CONCLUSION: Pristinamycin 3 G daily for 4 days is as effective and well tolerated as co-amoxiclav 2G daily for 8 days in the treatment of AECB.