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NCT ID: NCT05406453 Recruiting - Tuberculosis Clinical Trials

Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar

TB_WGS_cRCT
Start date: May 16, 2022
Phase: N/A
Study type: Interventional

Tuberculosis (TB) whole genome sequencing (WGS) allows outbreak identification and disease transmission tracking. It is hypothesized that prospective WGS-guided epidemiological investigations improve case detection compared to current best practices by adapting contact tracing strategies to local transmission patterns. A cluster randomized controlled trial (cRCT) will be performed in high TB incidence villages of Haute Matsiatra region in Madagascar. Communities will be randomized in three separate TB control strategies comparing (1) standard of care, (2) the World Health Organization (WHO) recommended best practices and (3) a novel intervention involving TB WGS cluster-guided epidemiological investigations. The incremental value of TB WGS on case notifications and reduction of TB burden will be measured. Secondary studies will be nested within this cRCT will include: - A qualitative study which will increase the understanding of the factors facilitating and hindering implementation of WGS-based diagnostics within health systems. - A cost effectiveness analysis study which will measure the cost effectiveness of newly implemented laboratory methods. Field and genomic epidemiology data from this project will inform future work on the design of community-level TB elimination strategies in collaboration with Madagascar National TB program

NCT ID: NCT05223933 Completed - Malaria Clinical Trials

Proactive Community Case Management (Pro-CCM) in Rural Madagascar

Pro-CCM
Start date: December 12, 2016
Phase: N/A
Study type: Interventional

The trial took place in a rural area hyper endemic for malaria, the hypothesis of which was that active detection and treatment of malaria in the population (all ages combined) in the event of a positive test could reduce the prevalence of malaria in the region. zoned. It was a two-armed, randomized, cluster-based community intervention trial: - one arm with home treatment of malaria for the duration of the study for patients with a positive result in the rapid diagnostic test for malaria. - a control arm with the usual malaria management procedures (ie consultation with community workers or the nearest health centers in the event of fever or suspected signs of malaria). Before the start of monitoring, an initial survey (Baseline) was carried out in the "fokontany" (villages / cluster) included in the 2 arms, in order to determine the prevalence of malaria. Then, in the intervention arm, screening for malaria by RDT every 2 weeks in subjects with a suspected malaria case (fever or notion of fever in the 2 days preceding the visit) and treatment with Artesunate-amodiaquine (ACT) for patients with a positive RDT. At the end of the follow-up period, a final survey (Endline), based on the same questionnaires as during the Baseline, was carried out in the 2 villages of the 2 arms. As a secondary objective, a study on anemia in women aged between 15 and 49 years was also carried out during the baseline and endline periods in order to compare the prevalence between the 2 periods

NCT ID: NCT05129696 Recruiting - Clinical trials for Early Childhood Development

Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo"

Start date: February 1, 2021
Phase: Phase 3
Study type: Interventional

The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar.

NCT ID: NCT04871230 Not yet recruiting - Tuberculosis Clinical Trials

Dried Blood Spot Test to Assess TB in Pregnancy

DROPTB2
Start date: October 1, 2021
Phase:
Study type: Observational

Despite being a key contributor to maternal mortality in high-burden regions, TB in pregnancy is a hugely neglected area of global public health. During pregnancy, the symptoms of TB are often overlooked and undiagnosed because they are vague, non-specific, and can be very similar to common complaints during pregnancy. Women with TB in pregnancy are at an increased risk of anemia and perinatal death. The DROP-TB project aims to expand the tuberculosis (TB) detection testing in pregnancy by creating a system where blood samples are collected from women at their local healthcare clinics instead of/or at national-level TB diagnostic centres where visits can require substantial travel and cost. Blood samples collected in specific RNA stabilizing tubes and on specific storing paper filters are collected from pregnant women with presumptive TB and transported to a central TB testing facility and analyzed by real-time polymerase chain reaction (qPCR). The DROP-TB method measures the mRNA expressions known to be markers of TB infection and disease. Based on veinous blood sampling, those signatures have showed high sensitivity (93%) and specificity (97%), can differentiate between active and latent infection, and performs well in the presence of other infections such as HIV. The DROP-TB program was specifically designed to increase the coverage of TB testing in pregnancy to improve health outcomes for women and their unborn children. The evidence generated from this program will demonstrate the feasibility of this program in providing TB diagnosis to women in rural and remote regions of LMIC with the example of Madagascar. Evidence will be presented to policy makers as a case to support the national scale up of the program in LMICs.

NCT ID: NCT04836208 Recruiting - Clinical trials for Enterobacteriaceae Infections

Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC

NeoLIC
Start date: April 30, 2021
Phase:
Study type: Observational

Enterobacteriaceae, more specifically Escherichia coli and Klebsiella pneumoniae, are the bacteria most often responsible for neonatal infections in low-income countries. Infections caused by multidrug-resistant Enterobacteriaceae: Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E), are more often associated with an unfavorable outcome of the infection. Enterobacteriaceae colonize the digestive tract which is the first step in developing a potential infection. Very few studies have been carried out at the community level. Colonization of the mother with ESBL-E is generally considered to be a major route of acquisition. The carrying of ESBL-E by other family members and other potential sources of transmission (food, objects and surfaces in contact with the newborn) have never been documented. In addition, with a view to offering an intervention adapted to the local context, the local cultural determinants which govern the interactions of the newborn with his environment are important to understand.

NCT ID: NCT04829630 Recruiting - Rabies Clinical Trials

Immunity Persistence After Abridged Intradermal Rabies PEP

RESIST-3
Start date: October 20, 2021
Phase: N/A
Study type: Interventional

After exposure, rabies can be prevented in almost 100% of cases by the administration of sufficient and timely post-exposure prophylaxis (PEP). PEP is based on wound cleansing, antisepsis, administration of rabies vaccine as well as rabies immunoglobulin, if reviewed. However, anti-rabies PEP remains too often out of financial and / or geographic access, especially for poor and / or rural populations in endemic countries who remain the most exposed to the risk of contracting rabies. Two major studies planned in Cambodia between 2014 and 2018 - the RESIST 0/1 clinical - epidemiological study and the RESIST-2 study on the antibody response to the vaccine - provided the basis that allowed a change in international recommendations on PPE. Since April 2018, the new "IPC protocol" of three sessions of reduced double doses (0.1 mL x 2) administered intradermally (ID) over one week has replaced the already very effective "TRC protocol" of four sessions over one month which was the reference dose-sparing protocol for endemic countries until 2018. It remains to be determined whether the IPC protocol (3 sessions / 1 week) confers long-term immunity equivalent to that obtained after a TRC ID protocol (4 sessions / 1 month). This question is of importance to public health decision-makers and clinical teams in endemic countries who would hesitate to switch to the abbreviated IPC protocol.

NCT ID: NCT04688996 Recruiting - Plague Clinical Trials

Yersinia Pestis Lateral Flow Immunoassay.

SMARTPRT
Start date: October 19, 2020
Phase:
Study type: Observational

Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could be used against US warfighters. Although this bacterium is ecologically established worldwide, it mostly affects impoverished people who live in rural low-resource areas of Madagascar. Plague is acquired directly from bites of infected fleas but, if left untreated, it can progress to the highly lethal pneumonic form that can result in human to human transmission. With the dangers of pneumonic plague in the context of both natural outbreak and as a bioweapon used against warfighter, the goal of this study is to investigate a diagnostic test that is able to rapidly and locally diagnose this disease in low-resource settings. This study aims to evaluate a US-developed new LFI (Lateral Flow Immunoassay) assay intended for capillary blood (finger-prick) to diagnose humans infected with Y. pestis. The investigators will rigorously validate with assay on human populations from active plague sites and correlate the results with the results of paired clinical samples used in standard medical workup using existing diagnostics tests.

NCT ID: NCT04562012 Recruiting - Plague Clinical Trials

Lateral Flow Assays for Pathogens of the Plague

SMARTPRT
Start date: October 19, 2020
Phase:
Study type: Observational

Plague is a deadly but highly treatable disease caused by the bacterium Y. pestis. Due to the historical development of Y. pestis as a bioweapon by several nation states, it is listed by the US as a potential bioweapon that could be used against US warfighters. Although this bacterium is ecologically established worldwide, it mostly affects impoverished people who live in rural low-resource areas of Madagascar. Plague is acquired directly from bites of infected fleas but, if left untreated, it can progress to the highly lethal pneumonic form that can result in human to human transmission. With the dangers of pneumonic plague in the context of both natural outbreak and as a bioweapon used against warfighter, the goal of this study is to investigate a diagnostic test that is able to rapidly and locally diagnose this disease in low-resource settings. This study aims to evaluate a US-developed new LFI assay intended for capillary blood (finger-prick) to diagnose humans infected with Y. pestis. The investigators will rigorously validate with assay on human populations from active plague sites and correlate the results with the results of paired clinical samples used in standard medical workup using existing diagnostics tests.

NCT ID: NCT04425434 Recruiting - Retinoblastoma Clinical Trials

Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma

GFARB12019
Start date: November 1, 2020
Phase:
Study type: Observational

As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.

NCT ID: NCT04425421 Recruiting - Burkitt Lymphoma Clinical Trials

Recommendations for the Treatment of Children With Burkitt's Lymphoma

GFALMB2019
Start date: November 1, 2020
Phase:
Study type: Observational

This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.