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Malaria - ClinicalTrials.gov

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Last Updated: 15 August 2022

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Malaria Surveillance in Rakai, Uganda

This report will determine the epidemiology of malaria infection in children and adolescents/adults by monitoring in approximately 320 households randomly selected from two of the Rakui Community Cohort Study's two clusters. Visit services include: structured interview/questionnaire of the primary care giver or legal guardian of the child; medical and laboratory evaluation of each child aged 6 months up to ten years; and the primary care giver; and the random selection of one additional randomly selected adolescent/adult resident of the household. In order to link medical records for study participants, the research team will monitor the usage of health clinic or hospital services within the district. This research will help the investigators develop their understanding of the epidemiology of pediatric and adult malaria infections in Rakai's Rakai district in preparation for future malaria vaccine trials.

Source link: https://clinicaltrials.gov/ct2/show/NCT01265407


The Malaria Heart Disease Study: A Novel Pathway to Subclinical Heart Disease

The aim is to clarify potential correlations relating to cardiovascular disease by invitation of a random sample of patients with a history of malaria, controls without a history of malaria, and chronic malaria-infected patients with persistent malaria infections. Adults with a history of treated malaria will have elevated left ventricular diastolic function and systolic strain, according to age- and sex-matched controls without a history of malaria. Aim 2: Define the extent to which proinflammatory factors are related to cardiac disease in patients with a history of malaria. The investigators predict that proinflammatory biomarkers will be higher in patients than in controls, and that elevated inflammatory markers may be associated with decreased LV diastolic function and strain. Aim 3: Determine if echocardiographic characteristics of systolic and diastolic function, as well as cardiac biomarkers in patients with symptomatic malaria are significant in patients with symptomatic malaria.

Source link: https://clinicaltrials.gov/ct2/show/NCT04445103


Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial Aim 2

In this report, the researchers will use a cluster controlled trial to determine the effect of two pioneering campaigns, a provider-directed reward for providing malaria rapid diagnostic services to suspected malaria patients and a consumer-directed diagnosis-based ACT subsidy. Before finalization of the study's design, all participants were registered, and all clusters will be allocated to one of the three remaining study arms only control, 2 client-directed interventions, and 3 combined client-and provider-directed interventions. The universal goal of universal access to prompt parasitological testing before treatment has been promoted, as well as the use of malaria RDTs in the public health sector at all levels of care. Retail stores in Kenya do not perform RDTs anymore, and a lot of emphasis has been placed on establishing community case management for malaria through community health workers and including performing RDTs. Customers who visit a participating store in any arm with fever or suspected malaria are eligible for an RDT at the research-approved price, as well as, in arms 2 and 3, a conditional ACT subsidy where the RDT is positive. Attendants will be trained to spot warning signs of danger and direct those individuals to a health facility for immediate care. Both the month and the interviewer assigned to the specific outlet will be randomized in order to balance data collection across interviewers and arms, as well as minimizing the observer effect. If you/he needed drugs for yourself or your minor child under the age of one year of age, the child is physically present, s/he had a febrile disease or suspected malaria, and he wants to be interviewed, you will be able to participate in the exit interview. Using the mobile app, study monitoring will be ongoing throughout the study period. The study staff will continue to review reporting data collected by the smartphone app. This monitoring measure will help us find major differences between the shop's claims and those that were not reported by the clients, such as testing results, RDT positivity rates, dispensing of eligible ACTs, and prices charged for RDTs and ACTs. SAMPLE SIZE AND POWER: The investigators established power based on a cluster random two-tailed t-test for the comparison of two proportions. The investigators will have > 90 percent power to find a minimum difference between Arms 1 control and 3 combined interventions in the primary outcome of 16 percentage points with a sample of 170 exit interviews per outlet 40 outlets in Kenya. For the main secondary comparison of interest testing uptake, the investigators will also have > 80% power to detect a minimum difference of 11 percentage points. The investigators will have a staff of 8 data collectors and each data collector will conduct about 50-60 interviews per month. Customer leaving the store will be approached by the field interviewer to ask if they are interested in participating in a short interview.

Source link: https://clinicaltrials.gov/ct2/show/NCT04428307


IGHID 12128 - Getting Malaria "Off the Backs" of Women and Children in Western Uganda

The proposed study, according to two centers in rural western Uganda, is a double-blind, randomized control trial of permethrin-treated lesus to prevent P. falciparum malaria in children 6 to 24 months of age. In each class, the total sample size would be 400 mother-infant pairs with 200 pairs in each group. Participants will also visit scheduled clinic visits every two weeks for routine monitoring of adverse effects and to look for asymptomatic infection. Every month, lesus re-treatment and sham re-treatment will take place. Outcome Measures: The key outcome measure is the incidence rate ratio of clinical P. falciparum malaria in infants and children aged 6 to 24 months old. With the incidence rate ratio, the ratio of the number of clinical malaria infections per 100 person-weeks at risk in the intervention group relative to the control group, will be estimated.

Source link: https://clinicaltrials.gov/ct2/show/NCT05391230


Community Dynamics of Malaria Transmission and Mosquito Feeding in Bancoumana and Doneguebougou, Mali

Inducing antibodies in vaccinees that block parasite growth in the mosquito interrupting infection has been a key to mosquito-stopping transmission. In vitro membrane feeding assays using immune sera and laboratory mosquitoes can determine vaccine effectiveness, but field-tested assays are required to determine transmission-blocking interventions in natura. TBV studies have started in Bancoumana and Doneguebougou, and we anticipate to expand TBV studies here and in nearby areas in the future. Individuals who are actively participating in the LMIV vaccine trials will be first screened for eligibility, which includes permission to notify their household and neighbors of their compound for enrollment. In conjunction with mosquito collections in/around village residences and with direct skin feeds using insecticide-raised mosquitoes, Malaria smears will be obtained at monthly visits. Parasite transmission to mosquitoes will be monitored longitudinally for changes by season and year, as well as between wild-caught and laboratory-raised mosquitoes. With no additional follow-up, the vaccine trial participants will complete a joint trip to obtain a blood sample for genotyping. The Parasite Surveillance Cohort will enroll participants under the age of 5 years and subjects of any age who are unable to enroll in DSF; they will be enrolled in DSF for the first time; mosquito testing and mosquito collection will be done at their house. The DSF Cohort's full enrollment will be linked to Enrollment into the Genotype and Parasite Surveillance Cohorts.

Source link: https://clinicaltrials.gov/ct2/show/NCT03304704


DON in Pediatric Cerebral Malaria: A Phase I/IIa Dose-Escalation Safety Study: Part 1-Adult Arm

The dose will be raised to 1. 0 mg/kg IV DON, followed by 5. 0 mg/kg IV DON, and then 11. 0 mg/kg IV DON, and then 11. 0 mg/kg IV DON, and then 10. 0 mg/kg IV DON, and then 10. 0 mg/kg IV DON, and then 10. 0 mg/kg IV DON, and then 10. 0 mg/kg IV DON, and then 10. 0 mg/kg IV DON, and then 10. 0 mg/kg/kg/kg/kg IV DON, 1. 0 mg/kg/kg IV DON, 5. 0 mg/kg IV DON, 5. 0 mg/kg IV DON, and 4. 0 mg/kg IV DON, and then 5. 0 mg/kg IV DON, then 4. 0 mg/kg IV DON, then IV DON, then 4. 0 mg/kg IV DON, and then 1. 0 mg/kg IV DON, and then 1. 0 mg/kg IV DON, IV DON, then IV DON, and then 4. 0 mg/kg IV DON, then IV DON, then Each adult dose group has 10 healthy participants and ten people with uncomplicated malaria. Adult participants will receive a premedication dose of the antiemetic ondansetron, 8 mg IV, 30 minutes prior to DON and repeated once 6 hours later. The time of study participation for all adult participants is six months.

Source link: https://clinicaltrials.gov/ct2/show/NCT05478720


Aggressive Antipyretics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance Effects

Despite continuing eradication efforts, malaria remains a significant public health issue in Africa, where approximately 250,000 children with malaria suffer a neurologic disease and subsequent neurodisability each year. Evidence shows that in children with CNS malaria a higher temperature during the acute illness is a risk factor for post-infectious neurologic sequelae. Previous clinical trials conducted mainly in children with uncomplicated malaria and using only a single antipyretic drug have shown limited success in terms of fever reduction; however, no studies have looked at malaria fever management using dual therapies to date. In vitro results that malaria parasite replication slows at higher temperatures and a single clinical trial in which peripheral parasite clearance was slower in children receiving fever treatment have been stifled in children receiving treatment for malaria. However, the connection between temperature and malaria parasite activity is vague. Every 6 hours for 72 hours, children hospitalized with CNS malaria will be randomized to regular care versuss. prophylactic acetaminophen and ibuprofen. Serial quantitative measurements of histidine rich protein 2, a P. falciparum-specific protein that aids estimates of whole body parasite burden and CNS parasite sequestration, will also be collected to explore the connection between antipyretic use and in vivo parasite behavior. The results of this research will determine whether or not a Phase III clinical trial of aggressive antipyretics for neuroprotection in pediatric CNS malaria should be conducted.

Source link: https://clinicaltrials.gov/ct2/show/NCT03399318


Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

Malaria-related morbidity and mortality have a significant economic impact in endemic areas and pose a significant health risk to non-immune travelers and people living in endemic zones. Potential healthy volunteers are continually monitored in order to build a database of volunteers for future and ongoing LMIV malaria drug, vaccine, or controlled human malaria infections research.

Source link: https://clinicaltrials.gov/ct2/show/NCT02639299


Determining the Impact of Scaling up Mass Testing, Treatment and Tracking on Malaria Prevalence Among Children in the Pakro Sub District of Ghana

In addition, IPT of children in a Ghana community has been shown to reduce the parasite load in a given community from 25% to 1%. This report will explore how to solve the issue of staff who are limited at the level of health care and coverage, as well as the growing network of community health workers that are used during vaccination programs. In the Pakro sub district, there are more asymptomatic malaria cases than those reported by hospital authorities, and the study shows that if MTTT is carried out in combination with home-based malaria treatment in specific communities over two years, a substantial portion of the parasite reservoir would be cleared, opening up the possibility of pre-elimination of malaria in the area. Following the WHO's recommendation, Ghana updated its malaria treatment guidelines by including artesunate and amodiaquine as the first line for treating uncomplicated malaria to replace chloroquine. Artesunate and amodiaquine combinations are not only effective at removing the malaria parasites from patients, but if used for intermittent preventive therapy for children under the age of five in Ghana, could effectively eliminate more than 90% of the parasite in this age group. Different studies have found a high prevalence of asymptomatic malaria parasitaemia in both younger and school age children who are at a higher risk of developing clinical malaria. The change in the prevalence of malaria among children aged 1 to 15 years in Cameroon has shown that the change in the prevalence of malaria accurately reflected a change in children aged 1 to 15. In a separate part of Africa, there has been a concerted effort over the past decade to investigate the possible effects of malaria mass vaccination using intermittent preventive therapy in children under the age of 5 in several areas. Associating IPTc with home-based malaria control by community staff, according to a longitudinal survey in Ghana, more than 90 percent of the parasite pool in children using artesunate and amodiaquine could be cleared in more than 90%. This report is designed to reduce asymptomatic parasitaemia in the Pakro sub district of Ghana's Pakro sub district of TB, age 2 months and older, and the administration of targeted therapy of all patients with confirmed asymptomatic parasitaemia or clinical malaria. In the Pakro sub district of Ghana, the main aim: To determine the effect of scaling up mass testing, diagnosis, and monitoring on malaria prevalence among children under the age of 15 in the Pakro sub district of Ghana. Study Plan: This is a clinical intervention study that will be conducted in 9 communities in the Pakro sub district of India's Pakro sub district to determine the cost effectiveness analysis of MTTT to the community. Arm 1's results will be compared to Arm 2's Arm 2's results will be compared to Arm 2. If positive, participants in Arm 1 will be tested every four months and treated if positive, while those in Arm 2, the MTTT test will only be carried out at baseline and at evaluation. The final hospital data will be collected in the 30th month, when community health of malaria will continue in community management until the 30th month. In-depth interviews will be conducted to obtain more data from the community and stakeholders, such as the NMCP, Regional and District units of the Ghana Health Service and the community. Study Area: Pakro is one of five sub-districts in the Akwapim south district health directorate DHD in Ghana's Eastern region. According to the Ghana Statistical Service GSS, the average household size in the Akwapim South district is expected to be 4. 0, while the average number of households per house or compound is expected to be 1. 6. The sub-district is made up of 22 communities and includes 3 health care facilities, 1 Health Centre, and 2 Community-Based Health Planning Service CHPS facilities. All 7 intervention communities that were located within a 5 km radius from the health center were chosen in consultation with the district health department. In a subgroup of children aged 2 months to 14 years randomly selected from all the families in each arm, with 460 children in Arm 1 and 395 children in Arm 2. In all children under the age of 15, the effects of the interventions on secondary outcome 2 will be observed. Sample size: This research seeks to enroll an entire population estimated at 4500 people from the 7 selected communities intervention arm and the 1500 from two control groups in Pakro sub district, with a population sample size of 4500 people. However, a sample of 368 children without adjustment for loss to follow up will be needed to determine the malaria prevalence expected in the study population, which is expected to be at 50%. The Ag P. f RDT Bioline, which detects histidinie-rich proteins II antigens HRP-2 Ag specific to P. falciparum in human blood, will be used in this study. Questionnaire: The questionnaire would include questions about malaria prevention, detection, and surveillance techniques used by the household members, as well as the cost of seeking medical assistance. The training of data collectors Two Community Health Workers CHWs will be selected from each neighborhood and prepared. The trained community members, who have seen signs and symptoms of malaria in the community, will be notified of the parasite using RDTs and report them to be delivering the parasite. To enable monitoring and linking of medical information with study participants, the user must fly to the health clinics that support the local community. paraphrasedl will be referred to the health center for children with severe anaemia Hb less than 7g/dl. When a family member is sick of malaria and wants to provide care, this will cover the time lost from time lost to providing care when a family member is sick of malaria. The malaria patients C5 will have cost the family incur in coping with each malaria case, with transportation C1, consultation C2, laboratory C3 and treatment cost C4 as well as total indirect costs estimated as lost in activity time as a result of caregiving to the malaria patients C5. The data will be first collected on paper based case report forms CRF before being entered into the database. If records are not validated due to mistakes or poor recording, a data query sheet is completed and returned to the individual responsible to correct the mistake before work resumes the next day. In the information technology IT unit of NMIMR, only to the IT unit and the PI will have access to this database, which will be known only to the IT unit's chief and the PI. All results of primary goal asymptomatic parasitaemia in each arm will be measured over time and between intervention arms using chi-square tests or fisher specific tests will be used to determine conditional logistic regression. Secondary goals: symptomatic parasitaemia at the hospitals and symptomatic parasitaemia in the community soared at the hospital and in comparison to intervention arms using chi-square tests or fisher exact tests and conditional logistic regression or conditional logistic regression. All the Expected Benefits - NPV - u2211PV of all the MTTT's estimated savings — u2211PV of all the estimated benefits - u2211PV of all the MTTT's associated costs — U2211PV of all the proposed work Associated Costs The estimated benefit estimate includes estimation, analysis and cost estimation. This is also a capacity-development effort. u2211PV edoutput: v Associated Costs Associated Cost ASPVencied Savings v. The overarching aim of this initiative is to increase research by examining the consequences of scaling up MTTT to minimize malaria morbidity and mortality. Quality Assurance In order to ensure the accuracy of data collected, 20 community health workers will be trained and 14 will be chosen for the program, and 20 will be selected for the initiative. All data from the field will be saved in the data transfer sheet to the data management unit to avoid data loss, so all records from the field will be transferred to the data processing unit to avoid data loss. Both ACTs AL and RDTs will be purchased from the NMCP through the Eastern Region medical store, with the exception of RDTs.

Source link: https://clinicaltrials.gov/ct2/show/NCT04301531

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions