L'étude s'intéresse à la bactérie Legionella pneumophila (Lpn) dans les biofilms des affluents du lac du Bourget. Elle confirme le caractère ubiquiste de cette bactérie, principalement sous sa forme non cultivable. Elle met aussi en évidence, le caractère local des facteurs naturels de régulation : seule la température de l'eau intervient dans la majorité des sites. Ce déterminisme local a aussi été mis en évidence avec l'étude du réseau hydrographique aixois qui reçoit à la fois des eaux thermales et celles de la rivière Le Tillet. Les perturbations thermique et chimique liées aux arrivées d'eau chaude sont détectables jusqu'à la partie aval du réseau. L'effet d'enrichissement des apports en Lpn qui leur correspondent reste localisé ce qui peut être la manifestation de processus naturels d'autoépuration. Nos résultats montrent également un comportement différent des organismes du groupe des Pseudomonas et des bactéries apparentées vis-à-vis des caractéristiques physico-chimiques. Des expériences effectuées en réacteurs biologiques ont montré qu'une augmentation de la vitesse ou de la température de l'eau est favorable à la présence de Lpn. Un modèle de transport de charges a été construit à partir duquel une gestion de l'utilisation du jet d'eau situé à proximité de la plage municipale d'Aix-les-Bains pourrait être faite pour tenir compte des périodes durant lesquelles des fragments de biofilms susceptibles de contenir des Lpn sont transportés en masse par le réseau aixois en direction de la plage. / The study concerns the occurrence of the bacteria Legionella pneumophila (Lpn) in biofilms from Lake Bourget tributaries. It confirms the ubiquity of the bacteria in flowing waters, but mainly as viable but non culturable state. It highlights that main environmental control factors are local, at the exception of water temperature which is involved in most studied sites. Local control of biofilms development has also been demonstrated in the study of the Aix-les-Bains hydrological network which receives hot springs water and water from the Tillet river. Thermal and chemical disturbances induced by hot waters entrances could still be detected at the farthest downstream part of the network. Biofilms enrichment in Lpn related to theses incomings kept localized possibly due to self-purification processes. Our results depict different answers of microorganisms like Pseudomonas and related bacteria towards physicochemical characteristics. Two experiments were performed based on biological reactors, showing that increases of water temperature or water flow, both enhance Lpn concentration. An hydrological transport model has been designed to serve the management of a waterspout sited by the Aix-les-Bains beach. It is written especially to address periods where biofilms transport holding high Lpn concentrations should be avoided.

Made available in DSpace on 2016-03-04T13:55:11Z (GMT). No. of bitstreams: 2 5.pdf: 1378527 bytes, checksum: b8a14bf9e69c73929eed3088b57f9940 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2014 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / A pesquisa clínica patrocinada pelas Indústrias Farmacêuticas vem sofrendo umrecente processo de globalização, particularmente envolvendo países emdesenvolvimento. Através da revisão bibliográfica realizada neste estudocomparamos os processos e realizamos um levantamento das respectivasnormativas vigentes aplicáveis para a aprovação de estudos clínicos demedicamentos no Brasil, Peru, Chile, Argentina, Estados Unidos, Reino Unido eJapão. Além disso, foram apresentados os aspectos positivos da pesquisa clínica noBrasil, assim como as principais dificuldades no processo de aprovação de estudosclínicos no país. A partir do estudo comparativo, foram apresentadas sugestões demelhorias para o processo de aprovação de estudos clínicos no Brasil e para asregulamentações aplicáveis ao país. Concluímos que apesar do Brasil apresentarum ambiente ético e regulatório bem estabelecido e alinhado com normasuniversais, a compreensão dos processos regulatórios de outros países, quemedeiam os respectivos trâmites para a aprovação de estudos clínicos, podecontribuir para a melhoria do processo de aprovação de um estudo clínico no Brasile para a sua respectiva regulamentação. / Clinical research sponsored by Pharmaceutical Companies has been suffering a recent process of globalization, particularly involving developing countries. Through a literature review done in this study, we compared the process and specific applicable norms related to the approval of drug clinical trials in the following countries: Brazil, Peru, Chile, Argentina, the United States of America, United Kingdom and Japan. Furthermore, we presented the positive aspects of clinical research in Brazil as well as the main difficulties of the approval process for clinical research in the country. Based on the comparative study, we presented suggestions to improve the clinical trial approval process in Brazil and for the applicable regulation. We concluded that although Brazil has a well-established and ethical regulatory environment aligned with universal norms, the understanding of the regulatory processes of others countries that mediate their procedures for approving clinical studies, can contribute to the improvement of the Brazilian approval process and its applicable regulation.