There are about 620 clinical studies being (or have been) conducted in Bangladesh. 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.
We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine alone in OP poisoned patients. We propose to compare the effect of two stat doses of nebulized salbutamol (2.5 mg; 5.0 mg), with nebulized saline placebo, in symptomatic patients receiving standard resuscitation with atropine, oxygen, and fluids after poisoning with OP pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary outcome will be oxygen saturation's over the following 60 min during resuscitation. Secondary outcomes will include atropine dose administered, speed to stabilization, aspiration or pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome will result in design of a large definitive phase III study.
- Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion using vital staining reduces unfavorable outcome of Cat. 1 first-line TB treatment without excess serious toxicity, and allows early switch to specific treatment of MDR-TB without using Cat. 2 retreatment regimen - General study design: This open label, randomised clinical trial is intended as a pilot study on the efficacy and safety of high-dose rifampicin and feasibility and added value of auramine and/or FDA vital staining sputum smear after 2 weeks of intensive treatment phase. If this proof-of-concept study provides substantial indication of benefit without indication of excess toxicity, the data from the study will be used to design a larger scale, cluster-randomized study. The aim of this cluster randomised study would be to provide definite proof of the benefit of the intervention on adverse treatment outcomes and lack of excess toxicity associated with high dose rifampicin. In addition, the cluster-randomized study would provide a more precise assessment of the suppression and prevention of (acquired) resistance endpoints. An interim analysis is thus planned at the time the last recruited patient finishes treatment, i.e. about 9 months after the end of recruitment. It will focus on assessment of drug toxicity versus suggested benefits of the intervention. This analysis will be primarily performed for the go/no-go decision and design considerations for the cluster-randomized trial. The decision on proceeding to the cluster randomized study will be based on the absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding relapse), and possible favourable effects on initially present low-resistance mutations / mutations acquired during treatment. It will also allow to adapt the design of the larger study particularly regarding the algorithm for resistance screening, and whether or not treatment shortening could be justified with rapid initial conversion.
Alternative, sustainable interventions in support of zinc treatment for childhood diarrhea need to be identified. Within the NGO sector, direct provision of health services is provided, however some NGOs also work closely with the private sector providers. Hypothetically, this avoids unnecessary duplication of effort and enhances the quality of the care provided in the private sector. This study will provide objective evidence of the impact of this approach, using the scale-up of zinc for the treatment of childhood diarrhoea as a test case. The study will be assessing NGO impact among unregulated (unlicensed), rural service providers. Further, this study will serve to assess the value of this model of scaling up activities in the non-state sector with a particular eye toward more generalizable and replicable improvement in quality of care strategies between NGOs and unlicensed private providers. This will be controlled before-after (CBA) study. An equivalent control area will be included in the study. The objective is to document changes in zinc and antibiotic as well as anti-diarrhoeal usage in childhood diarrhea following a scale-up intervention package delivered by a local NGO to local private providers. This will include sensitization, training and follow-up support. Impact will be assessed in terms of changes in zinc coverage and antibiotic use among households in the catchment population served by these providers. The study will be conducted in four unions located in Sreepur Upazila within Gazipur district, located north to Dhaka. Two of the unions, namely Rajabari and Prohladpur comprising 55 villages with 15,530 households and an estimated 76,150 population will serve as intervention area. The other two unions Telihat and Barmi will be taken as control sites. They contain 53 villages with 19,898 households and an estimated 99,000 population. The curative health services in these sites are provided by local drug vendors, village practitioners, traditional healers, and licensed government, private or NGO health service providers. Data will be collected through survey and in-depth interviews. Data will be entered and analyzed using SPSS version 12.0. Absolute counts, proportions, and means with 95% confidence interval will be calculated. These and regression analysis will be done using STATA version 9, cluster survey program, that accounts for potential within cluster homogeneity. Based upon the household surveys, the outcomes that will be calculated are: coverage-the proportion receiving zinc, ORS (zinc and ORS), and antibiotics or antidiarrhoeals and changes in coverage 6 months following the introduction of the intervention package, equity: who is receiving zinc by age, gender and socioeconomic status. For differences in categorical outcomes crude relative risks and 95% confidence intervals will be determined. It is expected that the study will help in increasing zinc coverage for the treatment of children under five years of age and decrease in the use of antibiotics and antidiarrhoeals within the NGO catchment population.
Diarrhea as of today is still a major problem in developing world with high morbidity. Though mortality in under-5 children has declined over the years, diarrhea was responsible for 2.5 million deaths per year in developing countries. A median of 3.2 episodes of diarrhea in under-5 children per child-year has been estimated in developing countries. In Bangladesh, the overall prevalence of diarrhea was estimated to be about 2% for the entire population. However, a recent survey in 2003 with urban slum mothers indicated that the prevalence of diarrhea ranged from 0.7-4.1% in six divisional cities with 0.7% in Dhaka slum areas. Malnutrition remains the major adverse prognostic indicator for diarrhea related morbidity, which emphasizes importance of nutrition in early management. Repeated episodes of diarrhea are a frequent cause and consequence of malnutrition. To improve diarrhea situation in Bangladesh and elsewhere, interventions are directed to reduce mortality and morbidity through improvement of breast-feeding practices, complementary feeding, sanitation, increase in measles immunization rates, micronutrient supplementation, and oral rehydration therapy. L-lysine, an essential amino acid, is required for healthy growth, tissue repair and enzyme production. It is a protein-building block that strengthens and nourishes the structural, circulatory and immune systems. It is not produced by the body like other essential amino acids and must be obtained from the diet. Some natural food sources for L-lysine include Lima beans, kidney beans, potatoes, corn, red meat, fish and milk. The mean requirement of lysine in healthy human adults is about 30 mg/kg body weight/day or 50 mg/g protein intake. Studies have shown that lysine therapy improves immune status and is used as a therapeutic agent in herpes simplex viral infection. A double-blind randomized trial of L-lysine treatment found it to be an effective agent for significant reduction in occurrence, severity and healing time for recurrent herpes simplex viral infection. Lysine fortification increased the blood levels of complement 3 (C3), CD-4 and CD-8 T-cells as compared with controls. These two studies suggest that supplementation of lysine through food fortification enhances immunological status. A few recent studies have also shown an effect of lysine on diarrheal incidence and severity. An experimental model suggested inhibitory effect of L-lysine on incidence of diarrhea induced by stress and 5-hydroxytryptamine. A community trial among adults in Syria showed that the period prevalence and mean duration of diarrheal illness were significantly lower in the female participants who consumed lysine-fortified wheat bread compared to the control group as well as better immunological parameters such as C3c delta. The proposed study will observe the impact of a daily dose of 2000 mg supplemental L-lysine for 6 months on diarrheal illness in an adult population of an urban slum area in Dhaka whose principal diet is based on cereals such as rice and or wheat. The daily protein and lysine availability from diets of Bangladeshi population has been calculated to be about 43g and 1883 mg respectively, compared to 113g and 7,598 mg respectively in the USA. This means that 2000 mg daily supplementation of L-lysine would not pose any detrimental effect, as the combined usual and supplemental intake will still be substantially lower compared to the intake in USA. However, as expected, the supplemental L-lysine may reduce the incidence and severity of diarrheal illness through improvement of the nutritional and immunological status of the study population. The investigators propose to conduct a community-based, double-blind randomized controlled trial in Mirpur area of Dhaka city. Adults aged 18 to 45 years residing in the catchment area for at least the last six months will be eligible for the study. A total of 440 subjects (220 females) will be enrolled. The results of the proposed study will contribute to our existing knowledge of the effect of lysine on incidence and severity of diarrheal illness as well as on immune status. A positive impact of lysine supplementation on diarrheal illness may lead to a future strategic approach to the control of diarrhea as a global public health problem.
To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.
The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.
An estimated 2.2 million children under the age of 5 years die from diarrheal disease each year. Most of the burden of diarrheal disease is thought to be preventable with improvements in sanitation, water quality, and hygiene. Large scale interventions promoting these behaviours have either not been rigorously tested or have not produced sufficient change to warrant being rolled out at scale. Research into the determinants of hand washing behaviour has identified disgust and shame as key motivators. Evidence supports the theory that disgust is a natural behavioural reaction to objects carrying disease risk, thus it may act as a key motivator for other health related behaviours such as water treatment. Whether this knowledge can be harnessed to increase the efficacy of hand washing and safe water campaigns in Bangladesh or elsewhere has yet to be rigorously tested. The investigators will develop an intervention that utilizes disgust and shame eliciting messages to promote hand washing with soap and point of use water treatment in low income housing compounds of urban Dhaka. The investigators will test the efficacy of this intervention against a more traditional public health intervention based on increasing knowledge of health risks and germ transmission using a randomized controlled trial. The study sample will be broken into the following four arms. 1. Standard Public Health Intervention with Water Treatment 2. Standard Public Health Intervention with Water Treatment & Hand Washing 3. Disgust and Shame Based Intervention with Water Treatment 4. Disgust and Shame Based Intervention with Water Treatment & Hand This design will allow us to compare outcomes for hand washing and water treatment between both standard public health interventions and disgust and shame based interventions as well as test the overall efficacy of the program comparing with the control. Data will be collected from all compounds at baseline, three month midline and at the six month endline giving us the practical and analytical benefits of a longitudinal dataset. Compounds will participate in interactive, educational safe water and/or hygiene promotion meetings. For the Disgust and Shame group, these meetings will emphasize disgust and shame related to unsafe water and/or hygiene practices, whereas the Standard group's meetings will resemble a more typical public health intervention explaining the risks and methods of contamination. At the first meeting, compounds will receive a one month free trial of the latest compound based chlorine dispenser model to treat their drinking water. A randomly selected half will also receive a one month free trial of the latest compound based handwashing station. At the end of the month, there will be a sales meeting in which the investigators will measure compound members' willingness to pay for the trialled products by giving them the opportunity purchase and keep the hardware in a Becker-DeGroot-Marschek (BDM) style auction. In assessing the impact of the interventions, the investigators are primarily interested in whether the prevalences of safe water and hygiene behaviours differ by treatment arm and over time. The best measurements for approximating behaviour prevalence are physical observations (presence of residual chlorine, hand cleanliness inspections), structured observation of behaviour, rapid physical observations (physical state of hardware/drinking water), self-report of water treatment and hand washing behaviour and willingness to pay for necessary products. The investigators will also attempt to measure and track changes in personal determinants of behaviour such as feelings of disgust and shame related to hand washing and water treatment behaviours.
Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation (VAS) from 6-59 months of age to reduce the risk of death in countries where VAD is common. Such countries include Bangladesh, where this study is being conducted. While providing VAS at 6 months is recommended, providing VAS at birth may also decrease the risk of death since newborn infants are also at risk of VAD. VAS presumably reduces infant mortality by improving the immune response to infection and immunization. Vitamin A particularly affects the development and function of T cells, which develop in the thymus and are a key component of the memory response to infection and immunization. Vitamin A is important for development of an important class of T cells, regulatory T-cells, in the intestine. Regulatory T-cells prevent over-reaction of the immune system to substances the immune system might otherwise treat as harmful such as food or the healthy bacteria in the intestine. VAD could disrupt the normal colonization of the infant's intestinal tract and cause a condition called "dysbiosis" where abnormal bacteria flourish and adversely affect the infant's immune system. Dysbiosis may disrupt the immune response to injectable and oral vaccines. VAS at birth may prevent dysbiosis and thus improve immune function, response to vaccines, and child survival. The investigators recently completed an intervention trial in Bangladeshi infants (NCT01583972) examining the effect of VAS at birth on immune function and response to vaccines administered from birth to 14 wk of age. The present study will recruit infants who completed NCT01583972 when they are from 12 to 24 m of age to determine if VAS at birth affects the responses to these same vaccines when they are measured during the second year of life. The investigators will examine the effect of VAS at birth on gut microbiota measured early in infancy and during the second year of life, and explore the association of the gut microbiota with vaccine response. Mothers of study infants will participate in the study because the breast milk oligosaccharide content strongly affects gut microbiota composition and the "secretor status" of the mother, which can be determined from maternal FUT2 genotype, strongly affects breast milk oligosaccharide content.
Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional epidemics seen during times of floods, cyclones or any natural disaster. It affects all age groups with the majority of fatal cases occurring in children . Therefore, immunization against cholera remains an important public health component in the prevention and control of the disease .The current two-dose regimen of the internationally available oral cholera vaccines (OCV) create a logistical and programmatic challenge for use in national programs or during epidemics ,so it is important to determine if a single dose vaccine will be protective in regions where cholera is endemic. If the vaccine is found to be efficacious following a single dose, this will have profound implications for the use of the vaccine in areas with limited resources particularly in complex emergencies where a multiple dose regimen is difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability' and allow the vaccine to be used for outbreak control, especially in difficult settings where the risk of cholera is extremely high and provisions for clean water and sanitation are not available. With low OCV production rates, larger populations could be immunized against cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate the inclusion of a global stockpile strategy. The study design is a two-arm individually randomized double-blind placebo-controlled trial. The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study treatment centres from 7 days to 6 months after dosage and whose identity is confirmed through home visit.
Diarrhea is the second leading cause of death in children worldwide, and accurately assessing dehydration status remains a crucial step in preventing morbidity and mortality from this disease. While children with severe dehydration require immediate treatment with intravenous fluids, children with mild to moderate dehydration have a significant reduction in hospital length of stay and fewer adverse events when treated with relatively inexpensive oral rehydration solution (ORS). While several clinical scales have been developed for assessing dehydration in children, these scales have never been prospectively validated in a low-income country setting, where the vast majority of diarrhea morbidity and mortality occurs in children. The investigators hypothesize that new clinical and ultrasound-based tools will improve the diagnosis of severe dehydration in children with diarrhea in low-income countries, reducing the morbidity and mortality that occurs as a result of under-diagnosis of severe dehydration as well as the adverse events and inappropriate utilization of scarce resources that occurs as a result of over-diagnosis of severe dehydration.