View clinical trials related to Cholera.
Filter by:The purpose of this study is to assess the safety and immunogenicity of Peru-15 (CholeraGarde®) vaccine in HIV seropositive adult population of Bangkok Thailand
Cholera is an important diarrhoeal disease and an important cause of death, particularly during epidemic outbreaks, in Bangladesh and many other developing countries. Used as an adjunct to management of dehydration, antimicrobial therapy using an appropriate agent reduces diarrhoea duration and stool volume in severe cholera by about half. The usefulness of antimicrobials has, however, been greatly eroded by the increasing prevalence of resistant strains of V. cholerae O1. From October 2004 at the Matlab Hospital and from December 2004 at the Dhaka Hospital of ICDDR, B, V. cholerae strains became increasingly resistant to tetracycline and erythromycin- two drugs used in the treatment of severe cholera in adults and children respectively. Because of this high prevalence of resistance we resorted in early 2005 to using ciprofloxacin for treatment against multi drug resistant V. cholerae. Although all isolates were susceptible to ciprofloxacin when standard thresholds for disc-diffusion or E-test were used, but majority of the strains demonstrated a MIC value of 0.250 µg/ml, over hundred-folds greater than the V. cholerae strains tested in earlier years, which generally had a MIC of <0.003 µg/ml. In this randomized, double blind, controlled trial we will assess clinical and bacteriological response to 12 hourly oral dose of ciprofloxacin for 3 days in which the first two doses will be 1 g each and the later 4 doses will be 500 mg each, and compare them with a single 1 g oral dose of azithromycin. We are using azithromycin as the comparator drug because current circulating V. cholerae isolates are susceptible (MIC ≤ 0.125 µg/ml) to this azithromycin, and single-dose azithromycin has been evaluated earlier to be effective in the treatment of cholera.
The purpose of this study is to conduct cholera vaccinations in high-risk populations in Zanzibar in order to estimate herd protection conferred by the vaccine,estimate effectiveness of the vaccine, and describe the interaction of vaccination and improved water supply on the burden of cholera and diarrhoeal diseases.
In cholera, the function of small intestine is affected resulting in increased secretion of electrolytes and water and their reduced absorption leading to profuse watery diarrhoea. The human colon has the capacity to absorb water and electrolytes. A number of recent studies have shown that short chain fatty acids (SCFAs) such as acetate, butyrate and propionate stimulates absorption of sodium in the colon, which is not affected by cyclic AMP. It has also been shown that SCFAs inhibits c-AMP mediated chloride secretion in the colon. Benefiber (partially hydrolyzed guar gum) is water soluble fibre, and when added to ORS it undergoes fermentation in the colon liberating SCFAs. SCFAs not only serves as metabolic fuel to the enterocytes but they also enhance colonic absorption of salts and water. Thus, they have potentials to reduce the severity of diarrhoea in patients with cholera. The aim of this study is to assess the efficacy of Benefiber-added WHO-ORS in the management of adults with cholera. In this randomized, controlled clinical trial, a total of 174 adult males with cholera would be studied. Study patients would be selected from those who attend the Dhaka Hospital of ICDDR,B with a history of diarrhoea of less than 24 hours and signs of severe dehydration. They would be rehydrated using intravenous fluid (cholera saline) over 4 hrs during which a stool specimen would be subjected for dark-field microscopy for identification of V. cholerae. Those identified to have cholera would be randomized in equal numbers to receive either: a) Benefiber (25 g/L) added WHO-ORS, b) Benefiber (50 g/L) added to the new formulation (Na+ 75, glucose 75, Cl- 65, K+ 20 mmol/L, citrate 10 mmol/L, osmolarity 245 mosmol/L) of WHO-ORS , or c) the same WHO-ORS but without Benefiber for maintenance of hydration until resolution of diarrhoea. All patients would be treated with a single, 300 mg dose of doxycycline capsules and would be provided with the standard hospital diets. Fluid intake (intravenous fluid, ORS, and plain water) and output (stool, urine, and vomit) will be measured for each 6-hourly periods of the study. Patients would be hospitalized until resolution of their diarrhoea. Stool output, intake of intravenous fluid and ORS, the duration of diarrhoea, and the proportion of patients requiring "unscheduled intravenous fluid therapy" would be compared between the treatment groups. If Benefiber is found effective, it would be possible to formulate improved ORS for better case management of cholera.
The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in infants when given simultaneously with measles vaccine.
In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine. Furthermore, the investigators also need to make sure that immune interference does not occur among all the other vaccine antigens given at the same time. Findings from this study will pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).
Cholera is a major health problem of many developing countries and marked increase in the prevalence has been seen on all continents in the last decade (WHO 1998). There is a great need for an appropriate vaccine to protect children the principal suffers in endemic countries, from the live threatening consequences of cholera. The B subunit-whole cell killed vaccine (Dukoral) developed in Sweden and used in field trials all over the world. It is licensed in many counties of the world and recommended by WHO. Protective efficacy to the killed vaccine has been demonstrated in adults in Bangladesh as well as in other countries, but less so in children (Clemens et al. 1986). Thus there is an urgency for developing strategies to improve the immunogenicity of vaccines especially for protection of children in cholera endemic countries of the world. Different options for improved cholera vaccines are being considered including new and improved formulations of killed or live oral candidate vaccines (Qadri et al. 2004, Sack et al. 1997, Levine et al. 1993) as well as the use of micronutrient supplementation during the course of immunization (Albert et al. 2003, Karlsen et al. 2003, Qadri et al. 2004). Another option that appears promising is the use of probiotics as adjunct to oral immunization based on the understanding that these agents could improve the mucosal immune responses, both innate and adaptive and help reducing inflammation (Blum and Schiffrin 2003, Fang et al. 2000). A therapeutic as well as preventive role of probiotics has been suggested from results of different studies using different probiotics that have been tested, usually lactic acid producing bacteria such as lactobacillus, Bifidobacterium and Steptococcus species. The supplemention of probiotics to infants may also have a prophylactic effect against acute diarrheal diseases. In pediatric populations, the effect of probiotic agents appears to be most significant against rotavirus diarrhea, suggesting that an immunological mechanism is responsible for the beneficial effects (Saavedra, 2000). In the present proposal we would like to examine if supplementation with the probiotic Bifidobacterium breve has a beneficial role in enhancing the immunogenicity of Dukoral in children. A two cell study will be conducted in which one group of children will be given B. breve every day for four weeks and another group will be given placebo. Two doses of the oral cholera vaccine will be administered at two week interval following initiation of the probiotic/placebo administration. Pre- and post- vaccination blood sample will be collected and assayed for immune response to the vaccine. The frequency and magnitude of the immune response to the vaccine will be compared among the two groups of children to assess whether the probiotic treatment enhances the immune responses to the vaccine. If probiotic supplemenation has a positive effect on the immune response it may be adopted as adjunct to enhance the efficacy of the cholera vaccine in immunization programmes and perhaps also of other enteric vaccines.
The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.
Cholera is a severe diarrhea illness caused by bacteria. The purpose of this study is to better understand how the immune systems of people in Dhaka, Bangladesh, fight infection with cholera. Understanding immune responses that influence the outcome of infection with cholera can assist in the development of more effective cholera vaccines. The International Center for Diarrheal Diseases Research, Bangladesh (ICDDR,B) will enroll in this study 75 patients with acute cholera and 250 of their household contacts. Individuals ages 2-60 years are eligible. Study participation will last 1 year for cholera patients and 30 days for household contacts. Participants will come to the ICDDR,B for 3 (household contacts) or 4 (cholera patients) study visits, and field workers will visit them at home at other times. For all participants, blood samples will be taken at each of the ICDDR,B visits. Household contacts will have rectal swabs taken at 2 ICDDR visits and during field worker visits.
The purpose of this study is to better understand how the body fights and protects against cholera. Two hundered fifty people presenting to the International Centre for Diarrhoeal Diseases Research, Bangladesh, admitted with acute cholera, 50 of whom (healthy, nonpregnant, 18-45 year olds) will be enrolled in this substudy of mucosal immunity involving duodenal biopsy. The remainder of the study is observational, involving collection of stool, vomit, and blood samples only. The biopsy requires a flexible tube with a camera be inserted through the mouth into the stomach and intestine. During this procedure, small samples will be collected from the intestine. The study includes medical history, physical, blood testing, hospitalization and urine pregnancy testing. This study will last for 5 years and patients will participate for 3 years.