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NCT ID: NCT04871230 Not yet recruiting - Tuberculosis Clinical Trials

Dried Blood Spot Test to Assess TB in Pregnancy

DROPTB2
Start date: June 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 Not yet recruiting - Clinical trials for Enterobacteriaceae Infections

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

NeoLIC
Start date: May 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 Not yet recruiting - Rabies Clinical Trials

Immunity Persistence After Abridged Intradermal Rabies PEP

RESIST-3
Start date: May 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: NCT04423484 Recruiting - Nephroblastoma Clinical Trials

Therapeutic Recommendations for Nephroblastoma

GFANEPHRO20
Start date: July 1, 2020
Phase:
Study type: Observational

The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.

NCT ID: NCT04145258 Recruiting - Clinical trials for Tuberculous Meningitis

Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis

INTENSE-TBM
Start date: February 9, 2020
Phase: Phase 3
Study type: Interventional

INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults with or without HIV-infection in sub-Saharan Africa: - Intensified TBM treatment with high-dose rifampicin and linezolid, compared to WHO standard TBM treatment. - Aspirin, compared to not receiving aspirin. The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment.

NCT ID: NCT04115072 Completed - Schistosomiasis Clinical Trials

Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study

Start date: September 3, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Female genital schistosomiasis (FGS) is a frequent manifestation of the infection with Schistosoma haematobium or mansoni. FGS is probably the most neglected gynaecological condition in the tropics. Inflammation of genital tissue persists as long as adult worms are present in the circulation, and new eggs are released. Hence, lesions can only heal if the inflammation is abated and a normal immune response is restored A randomized controlled study will be carried out to compare the efficacy of the standard treatment with that of five repeated doses of praziquantel. Outcome measure is the disappearance/regression of clinical pathology at the cervix, in the vagina/vulva.

NCT ID: NCT04110340 Recruiting - Plague, Pneumonic Clinical Trials

Ciprofloxacin Versus Streptomycin and Ciprofloxacin for Bubonic Plague

IMASOY
Start date: February 15, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to test the hypothesis that ciprofloxacin monotherapy given (orally, intravenously, or combination) for 10 days is non-inferior to streptomycin (given on days 1-3) followed by ciprofloxacin (given on days 4-10) in the treatment of bubonic plague. Secondary objectives are: -to collect data on the effectiveness of ciprofloxacin in the treatment of pneumonic plague, although the trial is not able to formally assess the non-inferiority of ciprofloxacin monotherapy compared to streptomycin and ciprofloxacin combination therapy in pneumonic plague. --to evaluate the level and kinetics of anti-Y. pestis antibodies of patients (bubonic and pneumonic plague) included in the study (anti-F1 ELISA techniques) at D1, D11, D21 and M3 for patients who are positive at D21. The tertiary objectives are: - to evaluate the level and kinetics of the levels of anti-Y. pestis antibodies and circulating F1 antigen of the patients (bubonic and pneumonic plague) included in the study (Luminex MagPix techniques with a Multiplex containing anti-F1 and rLcrV antigens and an F1 antigen capture multiplex) at D1, D11, D21 and M3 for patients positive at D21. - to evaluate the extent to which qPCR is positive in the blood of confirmed patients on D1. - to evaluate the performance of new rapid tests that may be made available to the Plague Unit of the Institut Pasteur de Madagascar.

NCT ID: NCT03998839 Active, not recruiting - Clinical trials for Malaria in Pregnancy

TIPTOP Sulfadoxine-pyrimethamine (SP) Drug Resistance Study

TIPTOP-DRS
Start date: March 5, 2018
Phase:
Study type: Observational

The main objective of this study is to monitor SP resistance via molecular markers in the context of the TIPTOP project implementation of community distributed SP for women during pregnancy. The specific objective is to detect trends over time in the proportion of symptomatic children with a positive rapid diagnostic test (RDT) residing in the areas where C-IPTp is implemented who carry parasites with dhfr/dhps mutations compared to those in control areas with no community SP distribution.