There are about 751 clinical studies being (or have been) conducted in Kenya. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.
Background: - Esophageal cancer is the sixth leading cause of cancer deaths worldwide. Two primary cell types, squamous cell carcinoma and adenocarcinoma, account for most cases. Of the two, esophageal squamous cell carcinoma (ESCC) accounts for more than 80 percent of all deaths from esophageal cancer. Many cases occur in certain areas with defined geographic boundaries, including parts of Kenya. - Studies of ESCC in developed countries (such as the United States) suggest that heavy tobacco and alcohol use, poor diet, and low socioeconomic status are the primary risk factors. Males and African Americans are also at higher risk. However, these risk factors do not fully explain the prevalence of cases in several of the identified geographic areas. - ESCC is the most common cancer seen at Tenwek Hospital in western Kenya, and a notable number of patients are 30 years of age or younger. Objectives: - To test the feasibility of a new protocol by recruiting visitors to Tenwek Hospital and volunteers from the general population for study purposes. - To use the new protocol to obtain blood and urine samples from ESCC cases in Tenwek Hospital and from nonpatient volunteers. Eligibility: - Hospital patients and volunteers who live within 50 kilometers of Tenwek Hospital in western Kenya. Design: - All participants will complete a questionnaire and provide blood and urine samples for testing. - The questionnaire will include questions about individual and family medical history, living conditions, lifestyle, habits, and diet. - Blood and urine samples will be collected from all participants after the questionnaire. - Biological samples will be shipped to the United States for further testing. - Treatment will not be offered as part of this study.
Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal cord, caused by the fungus Cryptococcus neoformans. CM most often affects people with compromised immune systems, like those with advanced HIV infection. This study explored the safety, tolerability, and therapeutic effect of a new treatment regimen with high-dose fluconazole for management of CM in HIV-infected patients.
Insecticide-treated nets (ITNs), and more recently long lasting insecticide nets (LLINs), have been shown to effectively protect those groups most biologically vulnerable to the burden of malaria across Africa. However, achieving universal coverage, especially in poor and remote areas, has proved a particular challenge and there remains a need to explore alternative delivery mechanisms. The recent introduction of universal primary education in Kenya has meant that even the poorest households are sending at least one child to school, providing a complementary, potentially equitable, mechanism through which to distribute LLINs. The delivery of LLINs through schools will be piloted by Population Services International in schools situated along the Tana River in North Eastern Kenya. This proposal seeks to evaluate the impact of this programme on both household use of school donated, free LLINs and the health of schoolchildren. The study hypothesis is that the free delivery of long lasting insecticide nets (LLINs) through schools will increase household LLIN coverage among younger siblings not enrolled in school and will reduce rates of malaria infection and anaemia among school children. The study will be an impact evaluation of a programme delivering LLINs through schools, which is to be implemented by Population Services International (PSI)-Kenya. The programme will be implemented in 50 schools and due to PSI-Kenya's roll out, the programme will be phased in over two years. will be phased in over two years. The 50 schools will be randomly divided into two groups, the first 25 schools will receive LLINs in 2009 and the second group will receive them in 2010. In each school, five households will be randomly selected and household surveys will be conducted to collect information on household net use and household demographic and socio-economic status. School health surveys will be completed at the end of the programme to assess programme impact on malaria infection and anaemia.
While malaria represents one of the main health problems afflicting schoolchildren, the evidence base for policy development and programme implementation for school-based malaria control remains inadequate. A recent study in western Kenya showed that delivering intermittent preventive treatment (IPT) to schoolchildren improved rates of anaemia and classroom concentration, but did not improve school performance. This study aims to (i) investigate the impact of malaria prevention using a strategy of periodic screening using malaria rapid diagnostic tests and treatment positives using artemether-lumefantrine (AL) on health and education among schoolchildren and (ii) determine the interaction between health and improved literacy instruction. The study hypothesis is that that school-based malaria prevention will reduce rates of anaemia or improve educational outcomes in Kenyan schoolchildren, when compared to comparison schools. In addition, a programme of training for primary school teachers to improve literacy instruction will improve literacy rates and there will be no interaction between the malaria intervention and the education intervention, such that learning will not be improved when teaching is effective and children are healthy. The study will be undertaken in 101 randomly selected primary schools in Kwale District. The malaria intervention consists of screening all children using rapid diagnostic tests (RDTs) for malaria. Children (with or without clinical malaria symptoms) found to be RDT-positive will be treated with AL according to national guidelines. Screening and treatment will be administered by district public health staff once a school term, observed by the evaluation research team. This intervention has been changed from IPT due to the withdrawal of amodiaquine in Kenya. The education intervention includes a programme of training for primary school teachers to improve literacy instruction. The study is designed to detect a 25% reduction in anaemia and an improvement of 0.2 standard deviations in mathematics and literacy tests. Additional outcomes will also be measured including malaria parasitaemia, classroom attention and school attendance. Cost-effectiveness and community acceptability of the interventions will be assessed. Anaemia and educational outcomes will be assessed before interventions and 12 and 24 months later. Malaria parasitaemia using blood slides will only be assessed at follow-up.
Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the first line treatment policy in Tanzania. AL is an efficacious drug that also has the capacity to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the development of parasite resistance against AL and there have been very few clinical trials that compared different ACT regimens. A recent clinical trial shows that the combination of dihydroartemisinin-piperaquine (DP) may be more efficacious than AL and may have a more pronounced beneficial effect on post-treatment malaria transmission. Screening for molecular markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment malaria transmission can assist in preventing the development and spread of ACT resistance. In the current study, the investigators compared AL and DP for the treatment of uncomplicated malaria. The investigators endpoints are - clinical efficacy - post-treatment gametocytaemia by molecular techniques - post-treatment malaria transmission.
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy. The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two moxifloxacin-containing treatment combinations to determine whether substituting ethambutol with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB.
Isoniazid preventive therapy (IPT) is a well studied clinical intervention for primary and secondary prevention of active tuberculosis (TB) after infection with Mycobacterium tuberculosis. It is widely used in industrialized countries in TB outbreak management, focusing on high risk groups such as close contacts in the family, in congregate settings, and in the workplace amongst others. Individuals infected with Human Immunodeficiency Virus (HIV) have a markedly higher risk of acquiring a TB-infection and developing consequently active TB, making HIV-infected individuals a target population for IPT. Studies of IPT in HIV infected persons in the nineties demonstrated the efficacy of IPT in the prevention of active TB in Sub -Saharan Africa and more recent studies suggest that the protective effect remains present in individuals on antiretroviral therapy. Despite the proven efficacy of IPT this intervention has not been taken up by most HIV and TB control programmes in Africa where the burden of TB/HIV is highest. The reasons for the low uptake of IPT are many and varied but include fears of expansion of isoniazid resistance and subsequently the development of multi -drug resistant TB with widespread use of IPT. Additionally screening protocols for excluding active TB and selecting persons for IPT have not been uniformly agreed upon. There have also been concerns that programmes designed to provide IPT may shift TB control programmes from their primary responsibility of finding and treating active TB. Finally it has been unclear as to which programme, between the HIV and the TB control programme, has the primary responsibility of managing the provision of the IPT intervention. The World Health Organization and other technical agencies engaged in global TB control have recently re-emphasized the need to scale up IPT. In this proposal we outline an operational research study to evaluate the introduction of IPT at community level and to measure its effectiveness at preventing TB. The study is based on the context of expansion of Community-Based Direct Observed Therapy Short Course (CB-DOTS), home-based care and the concept of HIV prevention with positives (PwPs), where there is a real opportunity to focus on the household as a source of HIV-associated tuberculosis. The study is designed as a cluster randomized trial. It compares the incidence of TB in household contacts including children under 5 of identified TB/HIV co-infected patients, who received IPT through proactive community intervention and those in a control group where the community was handled in the "usual way". In the intervention group household contacts of index cases of HIV positive, smear positive PTB will be visited at home and consenting contacts will be screened for active TB using a simple questionnaire. Those found to be fit will receive isoniazid 300mg (5 mg per Kg for children) once daily for 6 months, regardless of the HIV-status. Those found not to be fit will be referred for further evaluation at the nearest TB diagnostic centre. In the control group, routine care following national guidelines will be offered. This consists of contact invitation and assessment of eligibility for IPT, especially, in children less than 5 years. Both groups will be followed up monthly through household visits. Follow up will be for a total of 24 months including the six months when IPT is provided. A confidential HIV screening test will be provided to all consenting contacts in both intervention and control group after appropriate counseling. The primary outcome is the incidence of TB in the intervention and control household contacts. The difference in incidence between the two groups is a measure of efficacy of the intervention. In addition the efficacy of the intervention will be estimated stratified by HIV status of household contacts if data allows. Secondary outcomes are the incidence of adverse events, the incidence of TB-related symptoms, measures on the uptake of IPT (proportion of contacts starting and discontinuing IPT, treatment adherence) and programmatic indicators, i.e. percentage of persons eligible for IPT and resources needed.