View clinical trials related to Infection.
Filter by:Information from this study is needed to plan an eventual trial of a GAS vaccine in India if and when one is available. A GAS vaccine is currently a priority of the Indian Council for Medical Research (ICMR), and this project has been approved by the Joint Working Group (US and Indian Delegates) of the Vaccine Action Program, a joint effort of the ICMR and NIAID to implement cooperative efforts between the two countries on mutual objectives in vaccine development. Currently, several GAS vaccines are in development, supported by NIAID, and other sources, and one candidate is in phase one clinical trial authorized by the FDA. Information on the antigenic structure of GAS isolated in India will be needed for planning vaccine composition. It is the view of the Indian Ministry of Health and Indian Council for Medical Research that eventual prevention and control of rheumatic fever and rheumatic heart disease in India, now a heavy burden on the children will require a GAS vaccine, which requires both access to primary health care and a vaccine if and when it is available. Information on incidence is needed to determine the size of a future vaccine cohort in order to obtain a statistically significant result on vaccine efficacy. Although unrelated to vaccine development, information on the incidence of GAS pharyngitis is needed in India to implement primary and secondary acute rheumatic fever (ARF) and rheumatic heart disease (RHD) prevention programs as were implemented in the USA and Europe forty years ago. A vaccine trial is not part of this study, nor is there any intervention, other than antibiotic treatment of all children volunteers who develop GAS pharyngitis or impetigo. An additional point should be made about the importance of obtaining epidemiological data on streptococcal disease in India, and on the emm types of GAS that cause infections. The population of India is over one billion people, representing nearly twenty five percent of the world's population. Information on GAS epidemiology from India is scant to say the least, and it is sorely needed. We now know that streptococcal toxic shock syndrome and fasciitis that have occurred in the U. S., Europe, Australia, and Japan, with greater frequency in recent years are caused by several genetically similar emm types of GAS. The implication of such genetic and epidemiologic data is that these genetically related strains have spread worldwide, Current information from India is far too limited to know if these virulent strains of GAS occur in India, and if they do, to what extent might they be the cause of frequent invasive disease in hospitalized patients. Equally important, we do not know if a potentially high virulent GAS strain is currently emerging in some locale(s) in India, and what possible threat it might become, if it were to be transported to other worldwide geographic regions. Although not a specific aim of this proposal, the surveillance conducted to accomplish the aims of this protocol will provide essential information on the possible emergence of an unexpected emm type with pathogenic potential. ...
This study, sponsored by the National Institutes of Health and the Tuberculosis Research Centre in Chennai, India, will examine how helminth and filarial infections affect the immune response to mycobacteria (the bacteria that causes tuberculosis). Helminths are parasitic worms that infect the gut, and filaria are worms that circulate in the blood and infect various tissues. The findings of this study may affect how tuberculosis is assessed in Chennai, where filarial and helminth infections are common in the population. Patients between 6 and 65 years of age with helminth or filarial infections who do not have active tuberculosis, cancer, AIDS, or other immunosuppressive illness may be eligible for this study. Participants will be recruited from villages in the Chingleput District of Chennai, India. Participants will complete a medical history and physical examination. They will have a blood test to determine red blood cell count and to detect filarial infection, a stool examination to detect helminth infection, and a tuberculin skin test for tuberculosis. Patients with a positive tuberculin test will be treated for tuberculosis and any filarial or helminth infections that may have been detected. Patients whose tuberculin test is negative will be invited to participate in the second part of the study-to determine whether people with either filarial infections or helminth infections, or both, respond to tuberculosis bacteria in the same way as people who do not have these infections. Participants will undergo a review of their medical history, a physical examination, and a blood test to assess red blood cell levels and to look for evidence of filarial or helminth infection. They will then be randomly assigned to receive either albendazole and DEC (anti-helminth and anti-filarial drugs) or a placebo (look-alike tablets that do not contain an active ingredient). Two months later, patients will receive a second dose of the same tablets (placebo or active drug) they took previously, and after another 4 weeks they will be re-tested for tuberculosis. After 6 months (at the end of the study) all participants will receive anti-helminth and anti-filarial drugs and will have a repeat tuberculin skin test. Blood and stool samples will be collected twice in the 6-month period after the initial treatment to determine the levels of antibody against the parasites, to measure the level of infection with filaria, and to measure the level of red blood cells.
This study, conducted by NIH and the University of Bamako in Mali, Africa, will study the effect of concurrent infections with malaria and filariasis on patients' immune response. Lymphatic filariasis is caused by infection with very small parasitic worms called Wuchereria bancrofti that are acquired from mosquitoes. The worms may cause no illness in many who are infected, but is some, they can cause swelling of the arms, legs, breast and genitalia, which may progress to permanent swelling referred to as elephantiasis. Malaria is caused by Plasmodium falciparum, another parasite that is spread by mosquitoes. It can cause fevers, headaches, body aches and weakness, and, if untreated, it can cause severe illness and death. The 8-month study will analyze measures of immune function in blood cells from people with or without filarial infections who become infected with malaria. The goal of the studies is to see if having a filarial worm infection affects immunity against malaria. Results of analysis of immune function in persons with malaria but without filaria infections will be compared with those harboring both filaria and malaria infections and also with results from healthy control subjects. Healthy individuals and patients with malaria and filarial infections between 1 and 8 years of age and between 18 to 65 years of age who live in N'Tessoni and healthy individuals living in Bamako, Mali (controls), may be eligible for this study. Participants have blood samples collected as follows during the study: - A blood sample will be collected at the beginning of the study. Individuals found to have the filarial worm infection have a second sample drawn at nighttime when the filarial worms are present in the blood. Treatment for filaria infection will be offered to all infected individuals at the end of the study. - A second sample will be collected during malaria season. Subjects will be interviewed about their health during the malaria season and re-tested for filarial and malaria infections with a finger-prick test. Those who test positive for malaria will be offered treatment to begin immediately after collection of the donated blood sample.. - A third sample will be collected after the end of the malaria season. Subjects will be interviewed again about their health and re-tested for filarial and malaria infections with a finger prick test. Those who have positive results for either infection will be offered treatment after collec...
This study, conducted at the San Gerardo Hospital in Milan, Italy, will examine whether a bacteriocidal-coated endotracheal tube (breathing tube) cleaned with a device called a Mucus Shaver is safe and effective in preventing hospital-acquired infections in patients who require prolonged mechanical ventilation in an intensive care unit (ICU). Pneumonia is the most frequent hospital-acquired infection in the ICU; its development is likely related to the use of a breathing tube. The tube is placed in the patient's trachea (windpipe) to assist breathing during and after an operation. Currently, breathing tubes in intubated patients are cleaned with a suction catheter that draws out secretions that accumulate in the tube. This method does not clean the tube completely, however, and within a few hours after the breathing tube is placed, bacteria may begin to grow inside the tube. Over time, as the patient breathes in and out through the tube, the bacteria may break free and enter the lungs, possibly causing pneumonia. In addition, the growth of bacteria in the tube decreases the size of the airway passage, making it more difficult to keep air moving in and out of the lungs. Previous studies have shown that breathing tubes coated with silver-sulfadiazine prevented bacterial growth in the patient's airways and that use of the Mucus Shaver prevented accumulation of secretions in the lumen of the breathing tube, keeping the tube open. This study will determine if use of the coated tube and Mucus Shaver in patients requiring prolonged mechanical ventilation is safe and if it can reduce bacterial growth, the length of intubation and mechanical ventilation, the occurrence of pneumonia and the length of time in ICU and hospital. Patients at San Gerardo Hospital who are 18 and older, who expect to have a breathing tube in place for more than 48 hours, and who are not allergic to silver-sulfadiazine may be eligible for this study. Participants are randomly assigned to have either a standard breathing tube and standard cleaning or a coated tube cleaned with a Mucus Shaver. At intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. The lumen of the breathing tube is then cultured every day. When the tube is removed, or on the eighth day of intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. After the tube is removed, it is examined for biological and microscopic analysis.
This study will examine: 1) the safety and effectiveness of the drug doxycycline in reducing the number of Mansonella perstans (Mp) worms in the blood of infected patients, and 2) the effects of doxycycline followed by albendazole and ivermectin treatment for lymphatic filariasis, caused by the parasitic worm Wuchereria bancofti (Wb). Both Mp and Wb very small filarial worms that are spread by mosquitoes. Some people are infected with both Mp and Wb. Although most people do not become ill from infection with these parasites, some develop symptoms. Wb can cause swellings in the arms, legs, breast, and scrotum, and can progress to permanent swelling of the legs or arms called elephantiasis. Mp can cause itching, swelling, fever, headache, or other symptoms. Ivermectin and albendazole are medicines used to treat lymphatic filariasis. They eliminate the Wb parasite from the blood but do not affect Mp. Doxycycline is used to treat many kinds of infections and has also recently been shown to reduce the number of filarial worms in several types of filarial infections. The drug may be useful in Mp infections as well. Residents of Sabougou and nearby villages in Mali who are infected with the Mp parasite, are between 14 and 65 years of age, are in good health, are not pregnant or breastfeeding, and weigh at least 40 kg (88 lb) may be eligible for this study. They may or may not also be infected with Wb. Candidates are screened with a brief medical history and physical examination and blood tests to look for infection with Mp and Wb. Participants undergo a complete physical examination and medical history. Blood is drawn for routine blood tests. Participants are then randomly assigned to one of four treatment groups, as follows: 1) doxycycline for 6 weeks; 2) doxycycline for 6 weeks followed by a single dose of albendazole and ivermectin given 6 months after the beginning of doxycycline treatment; 3) a single dose of albendazole and ivermectin given 6 months after the beginning of doxycycline treatment; or 4) no treatment. Only patients infected with Wb receive albendazole and ivermectin treatment. All participants, whether or not they receive doxycycline, come to the clinic every day for 6 weeks. Every 2 weeks during this time, they have a blood test and, in women of childbearing age, a urine pregnancy test. After 6 months, they have a medical history, physical examination, and blood tests. Subjects in the albendazole/ivermectin treatment group are given the pills to take at that time. One year and three years after beginning the study, participants return to the clinic for a final history, physical examination, and blood tests. At the end of the first year of the study, all participants who tested positive for lymphatic filariasis but did not receive ivermectin and albendazole will be offered treatment with these medicines Ivermectin and albendazole will also be distributed by the Mali government to everyone in the villages as part of a program to eliminate lymphatic filariasis in the country.
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer. PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.
In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.
In the last years Structured Treatment Interruptions (STI) have been proposed to reduce HAART-related toxicity and to increase patients’ compliance. ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication. The two arms of the study will be compared in terms of immunological response (proportion of patients with CD4>500/mmc) at 2 years.
This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be associated with a reduced rate of adverse events, seen with long term use of antiretrovirals, as well as improved adherence compared to a twice daily fixed dose combination of Combivir.