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Helminthiasis clinical trials

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NCT ID: NCT06412926 Recruiting - Clinical trials for Soil-transmitted Helminth Infection

A Study to Learn About How Much Emodepside Gets Absorbed in the Blood and How Food Affects Its Absorption When Given as a New Type of Tablet to Healthy Participants

Start date: May 7, 2024
Phase: Phase 1
Study type: Interventional

Onchocerciasis or river blindness is an infectious disease caused by a parasitic worm. It spreads through the bite of an infected blackfly. Common symptoms include severe itching, skin problems, and eye problems including permanent blindness. Soil-transmitted helminthiasis is an infection caused by various parasitic worms, such as whipworm, hookworm, and roundworm in the intestines. The infection spreads through eggs found in the feces of infected people. This contaminates the soil in areas with poor sanitation. Common symptoms include stomach pain, loose stools, loss of blood and proteins, delayed development in children, and reduced work performance in adults. Researchers are looking for better ways to treat onchocerciasis and soil-transmitted helminthiasis. Emodepside is being tested for the treatment of onchocerciasis and soil-transmitted helminthiasis in both men and women. It works by activating a protein called 'SLO-1', which causes paralysis and death of the parasitic worms. The main purpose of this study is to find out if there is a difference in how emodepside gets absorbed in the blood when given as a new tablet compared to the existing tablet, as a single dose. Researchers also want to find the effect of food on the absorption of the new emodepside tablet. The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate and compare the following measurements after a single dose of the new and existing tablet of emodepside without food. The amount of emodepside in participants' blood will be measured at various time points. These will be used to calculate the Cmax and AUC after a single dose of the new tablet of emodepside with and without food. The number of participants who experience medical problems during this study will be documented. During this study, participants will receive 2 different types of emodepside tablets. These include the newly developed tablet and an existing tablet that has already been used in other clinical studies. At the start of the study, the researchers will ask participants about their medical and surgical history. They will also perform a health check-up for all participants, and pregnancy tests for women. During the study, participants will have blood and urine samples taken to check for any medical problems and to measure the amount of emodepside in the blood. The study doctors will confirm that the participants can take part in the study. This may take up to 21 days. This study has 3 or 4 periods and contains up to 2 in-house periods of 16 days each. On Day 1 of each period, participants will receive the treatments, but the order of the treatment will be different. • Periods 1 and 2: Each participant will receive a single oral dose of the new or the existing emodepside tablet without food. After Period 2, an initial analysis will be performed. This analysis will help decide the doses for the next periods. - Period 3: Participants will receive a selected dose of the new emodepside tablet either with or without food. - Period 4 (optional): If needed, participants may receive a selected dose of the new emodepside tablet either with or without food. The decisions to conduct Period 4 will depend on the results of the initial analysis. Participants will have a total of 6 additional weekly visits to the study site for sample collection after the last period (either Period 3 or 4). Participants will attend a follow-up visit to the study site 49 days after taking their last dose for a health check-up. This study will include participants who are healthy and will gain no benefit from taking emodepside. However, the results of the study will provide useful information to support the further development of the new emodepside tablet. The results will also provide information on the emodepside doses to be used in patients who need treatment with emodepside. Participants will be closely monitored by the study doctors for any medical problems.

NCT ID: NCT04813328 Recruiting - COVID-19 Clinical Trials

The Effect of Helminth Infection Plus COVID-19 Infection on the Immune Response and Intestinal Microorganisms

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

This is a pilot, cross-sectional, sample collection study to characterize the immune response and intestinal microorganisms in people with and without COVID-19 antibodies and helminth infection.

NCT ID: NCT04642755 Recruiting - Malnutrition Clinical Trials

Comorbidities and Coinfections in Latent TB

COMBINE-TB
Start date: April 19, 2021
Phase:
Study type: Observational [Patient Registry]

Approximately 2 billion people worldwide are infected with Mycobacterium tuberculosis (TB), with 90% of individuals having latent infection (LTBI). The control of TB requires clearly delineated helper T cell (Th) 1 responses and, to a lesser extent, Th17 responses, which both play important roles in the induction and maintenance of protective immune responses in mouse models of TB infection and in the prevention of active disease, as seen in LTBI. During latency, M. tuberculosis is contained in localized granulomas. Mycobacteria specific T cells mediate delayed type hypersensitivity reactions to purified protein derivative (PPD), and this reaction is generally considered to indicate an LTBI status in the absence of demonstrable active infection. Among the various risk factors that are known to play a role in promoting active TB, HIV is the most well studied and described. However, in low-HIV-endemic countries like India, other risk factors might play a more prominent role in active TB pathogenesis. These include malnutrition, diabetes mellitus (DM), and helminth infections. LTBI individuals with these comorbidities or coinfections could be at a higher risk for developing active TB than their "healthy" LTBI counterparts without these comorbidities. Thus, it is imperative to study the pathogenesis of TB infection and disease in these "at risk" populations. In this study, we will estimate the prevalence of severe to moderate malnutrition, uncontrolled DM, and helminth infections in LTBI-positive individuals. We will collect samples from a cohort of individuals with LTBI, those with LTBI and coexistent malnutrition, DM, or helminth coinfection, and those without any of these conditions. Individual participation may last up to 6 months. The main objective of the study is to estimate the prevalence of malnutrition, DM, and helminth infections in LTBI individuals. Simultaneously, we will perform transcriptomic, proteomic, and metabolomic assays, including profiles in serum and urine, to determine the biosignature portfolio of these individuals. In addition, immunological assays examining cytokine/chemokine signatures as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross talk between LTBI and malnutrition, DM, and helminth infections.

NCT ID: NCT01459146 Recruiting - Anemia Clinical Trials

Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana

ACTIPT
Start date: December 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if Artemisinin-based Combination Therapy, ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and school sustained attention and concentration.

NCT ID: NCT01308268 Recruiting - Helminthiasis Clinical Trials

Management of Soil-transmitted Helminthiasis and Strongyloidiasis

Start date: December 2010
Phase: N/A
Study type: Interventional

The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration regimen with albendazole and ivermectin.

NCT ID: NCT00001406 Recruiting - Clinical trials for Immune System Diseases

Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia

Start date: April 21, 1997
Phase:
Study type: Observational

This study will investigate how, why and under what conditions eosinophils (a type of white blood cell) become activated and will examine their function in immune reactions. Eosinophil counts often rise in response to allergies, asthma, and parasitic worm infections. They can also go up in uncommon autoimmune conditions and, rarely, in association with tumors. Elevated levels of these cells is called eosinophilia. Usually, eosinophilia causes no apparent symptoms, but in rare cases there may be local swelling and itching, allergic lung problems, heart disease or nerve damage caused by the release of toxic substances in these cells into body tissues. Patients 1 to 100 years of age with eosinophil counts greater than 750/ml or an abnormal accumulation of eosinophils in the skin or body tissues may be eligible for this study. All participants will have a thorough medical history, physical examination and blood tests. Depending on the person's age and symptoms, other diagnostic tests may be done, including specialized studies of the eye, lungs, skin, bone marrow, nerves or heart. This is not a treatment study, and no experimental treatments will be offered. Patients who require treatment will receive standard medical care. Certain other procedures may be requested solely for research purposes. All participants will be asked to donate extra blood for laboratory studies investigating how immune cells and other immune substances in the blood act to stimulate a rise in eosinophils. In addition, some participants may undergo one or more of the following: - Annual Follow-up evaluations - Physical examinations and blood tests to evaluate changes in the patient's condition and eosinophil counts over time. - Bone marrow biopsy and aspiration will be recommended during the initial evaluation, and in certain patients at other times when it is important to look directly at the newly developing cells in the bone marrow. For this procedure an area of skin and bone is anesthetized with xylocaine (an anesthetic similar to that used by dentists), and a very sharp needle is used to sample the bone marrow for evaluation. Bone marrow biopsy and aspiration can have side effects of pain and/or bleeding into the skin and soft tissues at the site of the procedure. Rarely the area at the biopsy site can become infected, and is treated with antibiotics. - Genetic testing: Some of the blood drawn from you as part of this study will be used for genetic tests. Genetic tests can help researchers study how health or illness is passed on to you by your parents or from you to your children. Any genetic information collected or discovered about you or your family will be confidential. - Leukapheresis (only patients 18 years and older) to collect large numbers of certain cells - In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm.

NCT ID: NCT00001230 Recruiting - Helminthiasis Clinical Trials

Host Response to Infection and Treatment in Filarial Diseases

Start date: March 15, 1991
Phase:
Study type: Observational

This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment. Filarial infections are caused by parasitic worms. The immature worm (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2 to 4 inches in length. Although many of these infections do not produce symptoms, especially in the early stages of infection, others can have serious consequences, including swelling of the limbs or genitalia, allergic-lung problems, skin rash, eye inflammation that can lead to blindness, and heart disease. This protocol does not involve any experimental diagnostic procedures or treatments, and will use only procedures employed in the standard practice of medicine. Persons between 3 and 100 years of age diagnosed with or suspected of infection with Wuchereria bancrofti, Bugia malayi, Onchocerca volvulus, Loa loa, or other parasitic worms may be eligible for this study. Participants will have routine tests to determine the specific type of filarial infection. These may include special tests of the lungs, skin or heart, depending on the type of parasite suspected. Patients with skin reactions may have a "punch biopsy" to examine a small piece of affected skin. For this procedure, an area of skin is numbed with an anesthetic and a small circular area, about 1/3-inch in diameter and 1/2-inch thick, is removed using a sharp cookie cutter-type instrument. Some patients may require bronchoalveolar lavage. For this procedure, the mouth and throat are numbed with lidocaine jelly and spray and, if needed, a sedative is given for comfort. A small plastic tube is placed in a vein to give medications. A pencil-thin tube is then passed through the nose or mouth into the lung airways to examine the airways. Salt water is injected through the bronchoscope into the air passage, acting as a rinse. A sample of the fluid is then withdrawn and examined for infection, inflammatory cells and inflammatory chemicals. (Bronchoalveolar lavage is done only if medically necessary and only on patients 21 years or older.) Once the diagnosis is established, standard treatment will be instituted with either diethylcarbamazine or ivermectin, depending on the type of infection. Additional procedures for research purposes include: - Extra blood draws to study immune cells and other immune substances. (This is the only research procedure that will be done in - More frequent and extensive follow-up evaluations than usual for routine care. They will include physical examination and blood studies. - Urine collections at specified periods, possibly including 24-hour collections. - Skin tests to examine the body s reaction to allergens-common environmental substances, such as cat dander or pollen-that cause an allergic reaction. The test is done in one of two ways: either the skin is lightly scratched and an allergen extract is placed over the just-broken skin, or a very fine needle is used to inject a small amount of allergen under the skin. In both methods, the site is monitored for swelling or hives in the next 48 hours. - Leukapheresis (only on patients 21 or older ) to collect quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.