Parasitic Infection

Researchers are evaluating the safety and effectiveness of levamisole given for either 3 or 5 days to treat loiasis, a parasitic disease caused by Loa loa. This trial addresses challenges in managing loiasis microfilaremia, particularly in regions where onchocerciasis and loiasis coexist, by testing levamisole as an alternative treatment to current therapies. The study is a randomized, double-blind clinical trial designed to see if longer levamisole treatment can reduce the parasite load safely and effectively. Participants are randomly assigned to one of three groups: a 3-day treatment of levamisole followed by 2 days of placebo, a 5-day treatment of levamisole, or a 5-day placebo group. Each dose of levamisole is 2.5 mg/kg. The study monitors treatment tolerance during the 5 days of administration and for 2 weeks afterward, while also measuring the effect on Loa loa microfilaremia from day 3 through day 30 after the first dose. During the trial, participants will undergo clinical examinations and complete questionnaires to assess health and safety. Researchers will track the parasite levels and any side effects through this period. The total participation involves treatment and follow-up visits extending up to 30 days post-treatment to evaluate both safety and parasite reduction outcomes.

Researchers are evaluating the safety and feasibility of a controlled human Plasmodium vivax malaria infection (CHMI) in healthy adult Thai volunteers. This study aims to find the best dose of cryopreserved P. vivax infected red blood cells for future studies by experimentally injecting these infected cells into volunteers. The study involves up to 48 participants, who will be closely monitored in a hospital setting, with the goal of understanding the infection process and treatment responses. Participants will receive one of four doses of infected red blood cells, ranging from a whole vial to diluted amounts, administered by injection. Each dose will be tested in groups of volunteers to identify which dose reliably produces infection. The study includes a screening period, a challenge day for infection, a monitoring phase until treatment criteria are met, and a follow-up period lasting one year after treatment. Volunteers will be admitted to the hospital for close monitoring, including daily health checks and blood tests to detect malaria parasites and assess immune responses. After infection is confirmed, blood samples will be taken twice daily until participants meet treatment criteria, at which point antimalarial drugs will be given. Follow-up visits will occur over the next year to monitor health, immune response, and possible parasite transmission. Safety and infection outcomes will be analyzed throughout the study period.

This research observes children who took part in the TEMPO clinical trial during their first year of life to understand if their early feeding patterns affect the development of allergies or infections in childhood. The study follows these children up to 7.5 years to gather information on allergic symptoms, infections, and related medical care. It is an observational study without additional treatments or interventions. Participants complete self-administered digital questionnaires every three months using a smartphone, tablet, or computer. These questionnaires collect data on allergies, infections, medication use, medical device use, hospitalizations, and emergency room visits. The study is entirely virtual and decentralized, allowing families to participate remotely. Throughout the study, parents provide information via regular online questionnaires, helping researchers track their child's health over time. The main measurements include parent-reported symptoms, medication or device use, and healthcare visits related to allergies and infections. The study runs until March 2029 and includes children aged 3 to 10 years who completed the original TEMPO study.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are studying a rare genetic condition called WHIMS, which causes severe neutropenia, a low white blood cell count that makes it harder for the body to fight infections. WHIMS leads to serious infections and complications like warts and cancers related to human papillomavirus (HPV). This research aims to evaluate the safety and effectiveness of a drug called Mozobil in treating neutropenia in people with WHIMS, exploring doses within the approved range. Participants will receive Mozobil through twice daily subcutaneous injections or continuous infusion using a pump. The study includes a dose escalation phase where doses increase over five days until white blood cell counts improve or the maximum dose is reached. After this, patients may enter a long-term phase receiving Mozobil once or twice daily for up to five years. Treatment will be paused for two days before starting Mozobil if participants are on certain white blood cell stimulating medications. During the study, participants will undergo medical history reviews, physical exams, lung and heart function tests, and blood and urine sampling to monitor safety and effectiveness. Researchers will track white blood cell levels, infection rates, and HPV-related skin lesions. Participants will also provide samples for further analysis and adhere to contraception requirements if applicable. The study may last up to seven years, with ongoing safety and response monitoring throughout.

Researchers are investigating whether adding a rapid biomarker test to current clinical guidelines can better identify young children with fever who are at risk of serious infections in sub-Saharan Africa. This study compares standard care based on integrated management of childhood illness (IMCI) guidelines alone to an approach enhanced by measuring suPAR levels, a biomarker, during the first clinical assessment. The goal is to see if this combined strategy improves decisions about hospital admission or discharge and leads to better health outcomes for children aged 2 to under 60 months. The trial is a multi-country, open-label, randomized study with two groups: one receiving the standard IMCI-based care and the other receiving IMCI care plus a point-of-care suPAR test. Blood samples will be taken from all children, but only the intervention group will have their suPAR levels measured immediately. Clinicians will use these results along with IMCI guidelines to decide whether to admit or discharge each child during the first clinical visit. A second, more detailed clinical assessment will also be performed on all participants to confirm or adjust decisions and ensure safety. Children will be followed up on days 3 and 7 after enrollment with additional visits if clinical worsening occurs. A day 28 follow-up will collect information on serious events, hospitalizations, or deaths, with an optional extra interview at three months. Participants with respiratory symptoms may join a substudy involving lung exams and sample collections. The study team will measure outcomes like the appropriateness of discharge decisions, hospital admissions, severity of illness, and mortality to evaluate the new triage approach's effectiveness and safety over these timeframes.

Researchers are evaluating a revised weight-based dose of tafenoquine (target dose 7.5mg/kg) to treat patients with vivax malaria. This Phase 3 trial aims to determine if this revised regimen is not worse than a high dose of primaquine given over seven days and if it is better than the standard fixed dose of tafenoquine. The study also looks at how well patients tolerate the revised dose and whether it is practical to use. Participants will be randomly assigned to one of three groups. One group will receive a single weight-based oral dose of tafenoquine along with schizontocidal treatment. Another group will receive a single fixed oral dose of 300mg tafenoquine plus schizontocidal treatment. The third group will receive schizontocidal treatment plus a high dose of primaquine given orally over seven days. The trial will monitor safety and effectiveness over several months. During the study, participants will be followed for six months. Researchers will assess the occurrence of vivax parasitaemia at 4 and 6 months as the main outcome. Other measurements include symptomatic vivax parasitaemia, anemia incidence at different time points, hemoglobin changes, adverse events, and methemoglobin levels. Participants must provide informed consent and live in the study area to allow regular follow-up and monitoring throughout the trial.

Researchers are evaluating the ability of LXE408 to reduce or clear parasites in the blood of people living with chronic Chagas disease who do not have severe organ dysfunction. This phase 2, randomized, participant- and investigator-blinded study aims to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of LXE408 compared to placebo and benznidazole. The study focuses on adults with chronic indeterminate Chagas disease without severe cardiac or gastrointestinal symptoms. Participants will be assigned to one of four treatment groups: LXE408 taken orally for 28 days, LXE408 for 14 days followed by placebo for 14 days, placebo for 28 days, or benznidazole for 60 days. This parallel group design allows comparison of LXE408 at different durations against placebo and an active standard-of-care drug. Treatments are all given by mouth, and the study includes a control arm to evaluate safety and tolerability alongside efficacy. During the study, participants will have blood tested by polymerase chain reaction (PCR) at months 2, 4, 6, and 12 to measure parasite levels and confirm clearance. Additional assessments include serology tests, pharmacokinetic blood sampling at multiple time points, and monitoring of adverse events throughout up to 48 months. Researchers will track time to parasite clearance and any treatment side effects while ensuring participants can comply with study visits and follow-up requirements.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) a new oral drug called E1018 in healthy adult volunteers. This early phase 1 study aims to understand how E1018 behaves in the body after a single dose and to monitor any possible side effects. The study includes adults from 18 to 55 years old who do not smoke or vape and have a healthy body mass index. Participants will receive single ascending doses of oral E1018 or a matching placebo in different groups. The study is randomized and double-blinded, meaning neither the participants nor the researchers know who receives the active drug or placebo to ensure unbiased results. Dosages are given on specified days, and the study includes several cohorts to assess the effects of increasing doses. During the study, participants will be closely monitored through physical exams, vital signs, laboratory tests, electrocardiograms (ECGs), and urine and blood sample collections to measure drug levels and safety markers. The primary outcomes include tracking any adverse events, dose-limiting toxicities, and detailed pharmacokinetic measurements up to 20 days after dosing. Participation involves regular visits for assessments and lasts through the observation period to ensure safety and gather data.

Researchers are evaluating the safety and immune response of a multi-stage malaria vaccine candidate combining R21 with RH5.1 and/or R78C in Matrix-M adjuvant. This Phase Ib open-label study includes healthy adults aged 18 to 35 years and children aged 5 to 17 months in Burkina Faso. The study aims to test different combinations of these vaccines to better understand their effects in populations living in malaria-endemic areas. Participants are divided into six groups. Adults receive three doses of 5 µg R21 plus 10 µg RH5.1 and 10 µg R78C. Children receive different combinations of 5 µg or 10 µg doses of R21, RH5.1, and R78C vaccines. Each participant receives three intramuscular injections at months 0, 1, and 6, either in the deltoid muscle for adults or the anterolateral thigh for children. Safety monitoring includes staggered recruitment, sentinel participants, and Data Safety Monitoring Board reviews before age de-escalation and subsequent vaccinations. Participants will undergo safety assessments for solicited and unsolicited adverse events at multiple time points up to one year following the first vaccination. Blood samples for immunology testing will be collected at screening, vaccination days, and several follow-ups up to day 365. The study includes ongoing monitoring of serious adverse events and immune responses to evaluate how well the vaccine combinations are tolerated and stimulate the immune system over time.