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Toxoplasmosis clinical trials

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NCT ID: NCT03948750 Completed - Clinical trials for Ocular Toxoplasmosis

Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis

COPILOT
Start date: January 1, 2010
Phase:
Study type: Observational

Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

NCT ID: NCT03932656 Withdrawn - Clinical trials for Borderline Personality Disorder

Latent Toxoplasmosis in Females With Borderline Personality Disorder

Start date: January 1, 2021
Phase:
Study type: Observational

Borderline personality disorder is a common mental disorder with core features of affective dysregulation, impulsivity, and identity disturbance. Although this disorder is mostly understood as a result of a combination of biological factors (genes, temperament) and early aversive experiences (often of traumatic nature), recent data suggest that other factors may be important in its development and course. Preliminary findings show that patients with borderline personality disorder have higher prevalence of Toxoplasma seropositivity. This infection may manifest in symptoms such as affective dysregulation, aggression, suicidality, or anxiousness. As such, it may play a role in the psychopathology of the borderline personality disorder. The aim of this study is to explore the prevalence of Toxoplasma seropositivity in a sample of females with borderline personality disorder, its clinical correlates, and a potential impact on outcomes of an intensive six-week inpatient schema-therapeutic treatment. Results may enrich our understanding of this disorder and lead to improvements of the therapeutic approaches.

NCT ID: NCT03385499 Recruiting - Clinical trials for Congenital Toxoplasmosis

New Diagnostic Approach for Congenital Toxoplasmosis

TOXODIAG
Start date: June 21, 2018
Phase: N/A
Study type: Interventional

Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. Neonatal biological diagnosis of toxoplasmosis is essential in the case of (i) suggestive clinical signs in the newborn with no information on the serological status of the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as possible to the newborn. Given the limitations of current diagnostic tests, the characterization of specific immunoglobulin (Ig)G neo-synthesized by the newborn would be of great help for an early diagnosis of CT. The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT (Enzyme-Linked Immunosorbent SPOT assay) method for detecting, in the newborn, B lymphocytes (LyB) sensitized in utero to produce T. gondii specific immunoglobulins (Ig) following a primary infection of the mother during the pregnancy. More precisely, the detection and quantification of LyB secreting IgG and IgM specific for T. gondii using the ELISPOT method will be applied i) to mononuclear cells of women in seroconversion following a toxoplasmic primo-infection during pregnancy and ii) to cord blood mononuclear cells of newborns suspected of CT, in comparison to positive and negative infection controls. To reach this goal, TOXODIAG is a diagnostic, multicentric, prospective, non-randomized, comparative and controlled study. It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP (Louis MOURIER, Bichat-Claude Bernard and Cochin) which ensure mother/child follow-up and biological sampling, with great gynecology and obstetrics expertise. Sixty women will be selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy (n=30), positive (n=15) or negative (n=15) toxoplasma serology. The necessary biological material will consist in additional blood tubes which will be taken at the same time as those performed for the usual pregnancy follow-up examinations and will correspond to maternal peripheral blood at inclusion, seroconversion and delivery as well as cord blood.

NCT ID: NCT03258762 Completed - Toxoplasmosis Clinical Trials

Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects

Start date: September 25, 2017
Phase: Phase 1
Study type: Interventional

Pyrimethamine in combination with a sulphonamide is known to be effective in the treatment of toxoplasmosis. However, Pyrimethamine has not been approved by the Japanese regulatory body (Pharmaceutical and Medical Devices Agency [PMDA]/ Ministry of Health, Labor and Welfare [MHLW]). The pharmacokinetics (PK) of Pyrimethamine has been investigated following administration of Sulfadoxine/Pyrimethamine tablet in healthy Japanese subjects. However, the study did not provide sufficient information for approval of Pyrimethamine in Japan; hence, PMDA has requested confirmation of the PK of Pyrimethamine in another PK study in Japanese and Caucasian healthy subjects. This study will be a single centre, open-label, parallel-group, single oral dose study to evaluate the PK, safety and tolerability of Pyrimethamine in healthy Japanese and Caucasian male subjects. Subjects will undergo a screening visit within 30 days prior to first dose of the study drug. On Day 1, subjects will be administered a single oral dose of pyrimethamine 50 milligrams (mg) along with calcium folinate 15 mg after an overnight fast of at least 10 hours. Subjects will continue to receive calcium folinate once daily until Day 8 of the treatment period. Blood sampling for PK analysis and safety assessments will be performed prior to dosing and over 22 days after dosing. Each subject will participate in the study for approximately 2 months from screening to follow-up.

NCT ID: NCT03226379 Completed - Clinical trials for Cryptococcal Meningitis

Driving Reduced AIDS-associated Meningo-encephalitis Mortality

DREAMM
Start date: April 23, 2016
Phase: N/A
Study type: Interventional

The DREAMM project is investigating whether the DREAMM interventions (1) Health system strengthening, 2) Co-designed education programs tailored to frontline healthcare workers, 3) Implementation of a diagnostic and treatment algorithm and, 4) Communities of practice in infectious diseases and laboratory capacity building) when combined reduce two week all-cause mortality of HIV-associated meningo-encephalitis in African LMICs.

NCT ID: NCT02936921 Recruiting - Clinical trials for Toxoplasmosis, Congenital

Lyon Cohort of Maternal and Congenital Toxoplasma Infections

Start date: January 1988
Phase: N/A
Study type: Observational

Several decades ago, France has made the choice to implement a national prevention program for congenital toxoplasmosis. The identification in their first trimester of pregnancy of all pregnant women who are susceptible to Toxoplasma infection has been mandatory since 1985. In 1992, the decision was made to extent the program to the monthly retesting of all women identified as not immune, in an attempt to reduce the number of severely infected children. The systematic detection of all maternal and congenital infections has generated many questions from clinicians, biologists, parents and older patients, on the short and long-term prognosis of congenital toxoplasmosis, on the best tests to use to diagnose infections in mothers and children, on the efficacy of existing treatments, and on how to manage patients in the long-term. The need to answer these many questions has prompted the medical team working within the laboratory and the outpatient department of the Parasitology Department at the Croix-Rousse Hospital in Lyon to implement a clinical research program. It is based on the systematic inclusion in our cohort of all pregnant women whose infection is confirmed, on their follow up, in order to monitor the outcome of pregnancy 2) and on the follow up of their children in order to confirm their infection or to rule it out. All congenitally infected subjects undergo clinical examinations, serological tests and ocular examination at least once a year without age limit. The following data are prospectively collected in a dedicated database: gestational age at maternal infection and corresponding serological profile; type and dates of maternal treatment; findings of ultrasound tests and amniotic fluid analysis; serological and clinical findings at birth; types and dates of postnatal treatment; postnatal serological profiles; infection status at one year of age; long term clinical (ophthalmologic) et serological findings. These data have allowed producing original findings on the risk of maternal-foetal transmission according to gestational age at maternal infection, on the long term ophthalmological outcome of congenital toxoplasmosis and to offer guidelines for the diagnosis, treatment and follow-up of maternal and congenital infections. These efforts are still to be maintained in the future in order - to further analyse the impact of puberty, pregnancy, or adult co-morbidities on the risk of ophthalmological events - to increase precision around our risk estimates for materno-foetal transmission, - to continue innovating in terms of diagnostic strategy to improve tests performances and reduce costs - to explore new potential clinical outcomes such as neuropsychiatric disorders associated with congenital and postnatal infection - to determine if infections due to oocysts could have different clinical outcomes than those due to the ingestion of cysts - to assess the efficacy of treatments for maternal and congenital infections

NCT ID: NCT02863588 Terminated - Clinical trials for Ocular Toxoplasmosis With Recurrences

Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis

TREXO
Start date: March 30, 2017
Phase: N/A
Study type: Interventional

Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. The overall recurrence rate of OT in Europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. These clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. The advanced analysis of the entire genome now possible to consider the project.

NCT ID: NCT02843438 Completed - Clinical trials for Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection

Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

BIOLUVE
Start date: January 2010
Phase: N/A
Study type: Interventional

Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical diagnosis of ocular toxoplasmosis is more complicated in presence of posterior neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful. Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host and the pathogen and there can trigger a crossed immune response. Stress proteins haven't been explored yet, in the context of toxoplasmosis uveitis on humans. The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers of ocular toxoplasmosis. The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG anti-Hsp70) in toxoplasmosis uveitis.

NCT ID: NCT02011750 Completed - Schizophrenia Clinical Trials

Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia

Start date: April 1, 2013
Phase: Phase 4
Study type: Interventional

This is an exploratory study in Egypt that will combine a treatment trial among early course schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically, the study will test the provocative results from animal studies indicating an impact of Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether exposure to TOX is associated with other cognitive and behavioral changes, as well as changes in overall social function. We will also explore the relative efficacy of Sodium Valproate (Depakote, DEP) in improving clinical and overall social function among TOX exposed and unexposed patients. Hypotheses 1. At baseline, TOX exposure is associated with increased novelty seeking, clinical severity, and impaired cognitive and overall social function in patients with SZ. 2. Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in SZ, particularly among TOX exposed SZ patients. 3. Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP and TH levels).

NCT ID: NCT01479361 Completed - HIV Clinical Trials

Antiretroviral Drug Interaction Study in Volunteers With HIV

Start date: October 31, 2011
Phase: Phase 1
Study type: Interventional

Background: - People who are infected with the human immunodeficiency virus (HIV) are at risk of getting certain diseases. Two of these diseases are a type of pneumonia known as PCP and a brain infection called toxoplasmosis. Most people with HIV take antiretroviral (ARV) drugs to treat HIV and lower the risk of infections. However, some ARV drugs may make other drugs used to treat PCP and toxoplasmosis less effective. Researchers want to test specific ARV drugs to see if they affect atovaquone, a drug used to treat PCP and toxoplasmosis. Objectives: - To see if ARV drugs atazanavir-ritonavir or efavirenz lower the blood levels of atovaquone. Eligibility: - Individuals between 18 and 70 years of age who have HIV. - Participants must be taking efavirenz or atazanavir-ritonavir, or not taking any ARV drugs. Design: - Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. - This study has a screening visit and five study visits. Two of the study visits will last about 12 hours; the other three visits will last about 1 hour each. - Participants will receive either a low dose or high dose of atovaquone to take for 14 days. They will record doses and any symptoms on a diary card at home. - After 14 days, participants will have a 12-hour visit to provide blood samples. There will be a wash-out period with no doses for up to 6 weeks. - After the wash-out period, participants will switch dose levels to either the high or low dose. - After 14 days, participants will have a 12-hour visit to provide blood samples.