Genomics to combat resistance against antibiotics for community-acquired lower respiratory tract infection (LRTI) in Europe (GRACE) work package 10: Antibiotic Trial One

Mise à jour : Il y a 4 ans
Référence : ISRCTN52261229

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Background and study aims This study is part of a programme of research into cough/chest infections across 12 European countries. Most people with chest infections probably don’t benefit from antibiotics and inappropriate antibiotic use drives antibiotic resistance, a major global health problem. Some groups of people however might really benefit from antibiotics. The study aims at understanding which subgroups of individuals with chest infections benefit from antibiotics, but also to study antibiotic resistance after antibiotic treatment. Who can participate? Throughout Europe 3000 adult patients presenting to primary care with acute cough or other symptoms that suggest a chest infection will take part in this study. What does the study involve? If the participating doctors think there is no definite need for antibiotics, participants will be asked to take a 7-day course of tablets to be taken three times a day. The tablets will be either amoxicillin, a very commonly used and safe penicillin-based antibiotic, or a placebo (a tablet without any medication in it). They will not be able to tell whether they will have the real antibiotic or the placebo. Random numbers are used to decide whether participants get antibiotic or placebo to make sure that they have an equal chance of getting either. This is the best way for us to show scientifically whether antibiotics really make a difference. If it is necessary to know whether participants are using an antibiotic or not, the participating doctors will be able to get that information at any time and change the participant’s medication. The participating doctors will also like to take one throat swab at day 8 (extra visit) and at the second study visit (day 28-35). The swab at day 8 will not be taken in all participants. If participants decide they do not want to have a swab taken at day 8 they can still take part in the treatment part of the study. What are the possible benefits and risks of participating? The main advantage is that the participating doctors will be well informed about the participants’ illness and will monitor them closely. In the future doctors will be able to provide better management for patients with coughs and chest infections, but this will not benefit the participants during this illness. The main disadvantages are the extra time and discomfort related to taking the additional swabs. The patients who will receive amoxicillin can experience the usual side-effects of penicillin: it can cause mild nausea or diarrhoea, and sometimes it can cause a transient skin rash. Where is the study run from? University of Southampton (UK). When is the study starting and how long is it expected to run for? October 2007 to April 2010. Who is funding the study? EC Sixth Framework Programme. Who is the main contact? Prof Paul Little


Critère d'inclusion

  • Lower Respiratory Tract Infection (LRTI)

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