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NCT ID: NCT04350905 Completed - Clinical trials for Vector Borne Diseases

Characterization of Skin Immunity to Aedes Aegypti Saliva in Dengue-endemic Participants in Cambodia

Start date: October 27, 2020
Phase: Phase 1
Study type: Interventional

Background: Mosquito-borne viruses like dengue cause major illness and death worldwide, particularly in Southeast Asia. When mosquitoes deliver a virus into the skin of humans, they also leave saliva. Researchers want to learn more about skin immunity to mosquito saliva. They hope this will help with future vaccines and treatments for these diseases. Objective: To compare the early and late innate immune response in the skin of Aedes aegypti bitten versus unbitten skin. Eligibility: Healthy people ages 18-45 who live within about 15 km of the study site in Chbar Mon Design: Participants will have 3 visits. The baseline/screening visit will include: Medical and medication history Questions about participants demographic information, mosquito biting risk factors, and responses to mosquito or other insect bites Physical exam Urine sample for some participants Mosquito feeding. A feeding device will be placed on the participant s arm for up to 20 minutes. The insects will feed through a mesh on the bottom of the feeding device. Participants may be given standard treatments for any skin reactions. Blood tests Four skin biopsies taken from bitten and unbitten skin. Local anesthetic will be administered, and a small tool will be used to remove the participant s skin. Participants will have a second visit the next day. They will have a physical exam and blood tests. They will have 1 skin biopsy. Participants will have a final visit about 2 weeks later. They will have a physical exam and blood tests. During the study, participants will be asked to take measures to prevent more mosquito bites.

NCT ID: NCT04311320 Completed - Clinical trials for Respiratory Distress Syndrome

A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits

Start date: March 26, 2022
Phase: N/A
Study type: Interventional

Purpose: Using a novel oxygen blender prototype with modified bCPAP to manage children 1 month to 5 years of age hospitalized with respiratory distress due to lower respiratory tract infection (LRTI) in low-resource settings is not associated with clinical failure within 1 hour of use. Aim: To investigate if this novel oxygen blender is safe to use among children 1 month to 5 years old hospitalized for respiratory distress from lower respiratory tract infections in a low-resource setting.

NCT ID: NCT04285021 Completed - Sepsis Clinical Trials

Prediction of Disease Severity in Young Children Presenting With Acute Febrile Illness in Resource-limited Settings

SPOT-SEPSIS
Start date: March 5, 2020
Phase:
Study type: Observational

Note that this is a study that is co-sponsored by Medecins Sans Frontieres, Spain, and the University of Oxford. The primary objective is to develop a risk prediction algorithm, combining measurements of host biomarkers and clinical features at the point-of-triage, for children with an acute febrile illness in resource-limited settings. The secondary objectives are to determine which host biomarkers, feasible for measurement at the point-of-care, are predictive of disease severity. Additionally to determine the optimal combination of clinical features (including demographics, anthropometric data, historical variables, vital signs, clinical signs and clinical symptoms), feasible for assessment by limited-skill health workers, that is predictive of disease severity. The tertiary objectives are to explore the impact of different methods of outcome classification on development of the risk prediction algorithm, and to explore the performance of the algorithm to predict disease severity in key presenting clinical syndromes and aetiologies.

NCT ID: NCT04177654 Completed - Clinical trials for Soil-transmitted Helminth Infections

Monitoring Drug Efficacy and Anthelmintic Resistance in Soil-transmitted Helminth Programs

StarwormsWP2
Start date: May 15, 2019
Phase:
Study type: Observational

Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem. The overall aim of this study is to pilot a surveillance system to assess anthelmintic drug efficacy and the emergence of AR in 9 countries were drug pressure has been high over a long period of time. The specific objectives are to: 1. Assess the prevalence of moderate/heavy intensity infections of the different STH 2. Assess the drug efficacy of a single dose of BZ drugs against STH infections in these countries 3. Assess the frequency of the ß-tubulin SNPs linked to BZ resistance 4. Identify implementation-related barriers and opportunities for monitoring drug efficacy and AR in national PC programs for STH. 5. Expand the Starworms repository of STH field samples

NCT ID: NCT04169971 Completed - Anxiety Clinical Trials

Investigation of the Effects of Music on Anxiety During Operations Under Spinal Anaesthesia at an Hospital in Cambodia

Start date: October 28, 2019
Phase: N/A
Study type: Interventional

This study investigates he effects of intra-operative music on anxiety levels during procedures under spinal anaesthesia at a surgical centre in Cambodia. Participants will be randomly allocated to either the music (M) group or the 'control' (C) group. The M group will receive music played through headphones for the duration of the operation. The C group will receive no music or headphones. Anxiety will be measured in both groups, through a visual analogue scale (VAS), at the beginning of the operation and after 30 minutes of the procedure. Scores will be compared.

NCT ID: NCT04139941 Completed - Clinical trials for Hepatitis C Virus Infection

Evaluation Study of HCV RDTs in Fresh Samples

Start date: July 31, 2019
Phase:
Study type: Observational

This study evaluates the sensitivity and specificity performance of three Hepatitis C Virus (HCV) rapid diagnostic tests (RDTs) in freshly collected fingerstick whole blood, as well as serum and plasma (Premier Medical Corporation First Response HCV RDT; Beijing Wantai HCV RDT; AccessBio Care Start HCV under development). Performance is compared to the SD Bioline HCV RDT, as well as a composite reference standard, consisting of two enzyme Immunoassay and a line immunoassay.

NCT ID: NCT04094350 Completed - Tuberculosis Clinical Trials

Effect of Community Active Case Finding Strategies for Detection of Tuberculosis in Cambodia

Start date: December 16, 2019
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is a highly stigmatized disease, and approximately one-third of the Cambodian population living with TB are undetected. Therefore, it is vital to find these missing cases and promptly link them to care to reduce disease progression and interrupt further transmission. The integration of community-based, peer-driven intervention in TB active case finding (ACF) is relatively novel. In partnership with KHANA, the National Center for Tuberculosis and Leprosy Control (CENAT), and the Cambodia Anti-Tuberculosis Association (CATA), we will conduct a pragmatic cluster randomized controlled trial comparing 1) the ACF with the seed-and-recruit model; 2) ACF targeting household and neighborhood contacts; 3) ACF targeting the older population using mobile screening units; and 4) passive case finding (PCF) approach. The primary outcome will be the case notification rate in the intervention and control districts during the study period. We will also determine additionality, comparing the yield in each arm with its respective historical baseline and the cumulative yield over the implementation period. The secondary outcomes include the number needed to screen to detect one TB case, cost-effectiveness (direct and indirect costs per TB case notified), and the treatment outcome of all people with TB in this study. The project will be carried out over two years in eight operational districts (province name in parenthesis) - Koh Soutin (Kampong Cham), Stong (Kampong Thom), Kanchreach (Prey Veng), Choeung Prey (Kampong Cham), Dambae (Thbong Khmum), Boribo (Kampong Chhnang), Ponhea Leu (Kandal), and Phnom Srouch (Kampong Speu) - in Cambodia. The selection was also based on the number of health centers to increase comparability and generalizability of study findings. This study will randomize currently underserved operational districts (without active intervention at least in the past six months from the implementation date) to receive the interventions (ACF) and PCF as the control. The results from this proposal will enable a nationwide scale-up of an effective intervention that is contextualized and complies with the principles set by the national TB program to find undiagnosed cases and control TB in Cambodia. Also, this project will complement existing ACF programs in Cambodia by expanding ACF to other operational districts that are currently not served by the Global Fund, its implementing partners, and other organizations. Findings from this trial could also potentially inform active case finding strategies in other countries with a high TB burden.

NCT ID: NCT04041973 Completed - Malaria Clinical Trials

Study to Assess Efficacy of Artemether-lumefantrine Prophylaxis Against Forest Malaria in Cambodia (PAL_Cambodia)

PAL_Cambodia
Start date: March 11, 2020
Phase: N/A
Study type: Interventional

In the Greater Mekong Subregion (GMS) adults are at highest risk for malaria. The most relevant disease vectors bite during daytime and outdoors which makes forest work a high-risk activity for malaria. The absence of effective vector control strategies and limited periods of exposure during forest visits suggest that chemoprophylaxis could be an appropriate strategy to protect forest workers against malaria. The investigators propose the use of Artemether-lumefantrine (AL), a drug whose efficacy remains high in the GMS, unlike, for example DHA/piperaquine [20]. The proposed study will help to assess the efficacy and feasibility of prophylaxis to prevent malaria in forest workers, help to identify the optimal regimen, and predict its efficacy in reducing overall transmission. The proposed study is a critical step for future use of chemoprophylaxis to protect forest workers in the GMS against malaria. Funder: Wellcome Trust of Great Britain grant number 106698/Z/14/Z and 220211.

NCT ID: NCT03939104 Completed - Clinical trials for Plasmodium Falciparum Malaria (Uncomplicated)

A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)

DeTACT-ASIA
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine + amodiaquine (AL+AQ) and artesunate- mefloquine+piperaquine (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo (AS-MQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.

NCT ID: NCT03831906 Completed - Covid19 Clinical Trials

Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia)

Start date: March 20, 2019
Phase: N/A
Study type: Interventional

Despite progress in reducing tuberculosis (TB) incidence and mortality in the past 20 years, TB is a top ten cause of death in children under 5 years worldwide. However, childhood TB remains massively underreported and undiagnosed, mostly because of the challenges in confirming its diagnosis due to the paucibacillary nature of the disease and the difficulty in obtaining expectorated sputum in children. Pneumonia is the leading cause of death in children under the age of 5 years worldwide. There is growing evidence that, in high TB burden settings, TB is common in children with pneumonia, with up to 23% of those admitted to hospital with an initial diagnosis of pneumonia later being diagnosed as TB. However, the current World Health Organization (WHO) standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. Hence, TB is often under-diagnosed or diagnosed late in children presenting with pneumonia. In this context, the investigators are proposing to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra, performed on NPAs and stool samples, to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples. TB-Speed Pneumonia is a multicentric, stepped wedge diagnostic trial conducted in six countries with high TB incidence: Cote d'Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia. The sub-study on Covid-19 will assess the prevalence and impact of the Covid-19 in young children hospitalized with severe pneumonia. The sub-study findings are expected to guide policy makers and clinicians on potential specific screening and management measures for these vulnerable groups of children. They are also key to analysing TB-Speed Pneumonia results on mortality in a context of the Covid-19 outbreak and to take into consideration SARS-CoV-2 infection status in the main study analysis.