Extrait

Background and study aims Approximately 10% of patients being treated for tuberculosis (TB) each year in Malawi have already received one course of TB treatment. A first episode of TB is treated with a standard course of tablets for six months. For patients who require treatment for a second episode of TB, the World Health Organisation recommends that they should receive tablets for eight months, and also have daily injections of the antibiotic streptomycin for the first two months of the treatment course (this treatment is called ‘re-treatment regimen’). Currently, the only way for patients to receive these injections is to be admitted to the hospital for two months. There are many potential disadvantages to these long period of hospital admissions, including financial and social costs to patients and their households, economic costs to health systems, and risks of patients acquiring infections from being in the hospital. The aim of this study is to test whether these patients can be managed in the community rather than in the hospital. Who can participate? Any adult, aged 16 years or older, who is being registered to start TB re-treatment regimen at the participating hospitals, can be enrolled into the study. What does the study involve? Patients recruited to the study will identify a guardian who, if they are willing, will be trained how to give the injections. During the period when the guardian is being trained, the patient will stay in the hospital. Of the patients whose guardian successfully learns how to give the injections, half will stay in the hospital for 2 months in order to receive the injections, and the other half will go home where their guardian will give them the injections every day. The study team will visit the patients at home every 1 to 2 weeks, and more often if there are any problems. The outcome will be compared. Social and economic factors associated with hospital and community management will also be assessed. What are the possible benefits and risks of participating? The possible benefit of participating in the study is that patients and guardians will be able to return home rather than staying in hospital for 2 months. The risks of participating in the study are mainly those related to unsafe injection of streptomycin by guardians in the home. The main concerns are that the injections could introduce infections if not done in a sterile, germ-free way, or cause damage to nerves supplying the leg if they are given at the wrong position. In order to reduce these risks, thorough training and strict assessments of guardians will be made prior to discharging the patients, so that, only those patients who have a guardian able to safely give injections are sent home. Where is the study run from? The study will be run from two central hospitals in Malawi – Queen Elizabeth Central Hospital in Blantyre, and Bwaila Hospital in Lilongwe. When is the study starting and how long is it expected to run for? The study is starting in June 2013, and it is expected to run for up to 2 years. Who is funding the study? The Wellcome Trust (UK) Who is the main contact? Dr Danielle Cohen [email protected]

Critère d'inclusion

• Community management of patients requiring injectable therapy as part of the TB re-treatment regimen

Liens

• ictrp
• isrctn