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 mgkg. 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 childs 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 drugs 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 evaluating a new strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

Researchers are evaluating a revised weight-based dose of tafenoquine target dose 7.5mgkg 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 LXE408 in adults with chronic Chagas disease without severe organ dysfunction. This study is a phase 2, randomized, participant- and investigator-blinded, controlled trial with four treatment groups. The goal is to assess the effectiveness, safety, tolerability, pharmacokinetics, and pharmacodynamics of LXE408 compared to placebo and benznidazole in clearing or reducing parasites in the blood. Participants are randomly assigned to one of four 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. The study monitors parasite clearance using PCR tests at multiple time points, including early clearance at days 7, 14, and 28, and sustained clearance for up to 12 months. Pharmacokinetic measurements of LXE408 are also taken during treatment. Participants will undergo regular assessments including PCR testing for parasite levels at months 2, 4, 6, and 12, serology tests at months 6 and 12, and monitoring for adverse events up to 48 months. Safety evaluations and pharmacokinetic blood samples are collected during treatment. The total study duration extends up to 6 years including long-term follow-up to track treatment impact and participant health.

Researchers are evaluating the safety and immune response of a multi-stage malaria vaccine candidate combining R21 with RH5.1 andor 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 g R21 plus 10 g RH5.1 and 10 g R78C. Children receive different combinations of 5 g or 10 g 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.

Researchers are studying the safety and immune response of different dosing schedules and reduced doses of the RTS,SAS01E malaria vaccine in healthy children aged 5 to 60 months living in areas where malaria is common. This Phase 2a open-label randomized study aims to find the best vaccination regimen to protect young children against malaria, a serious infectious disease. The study is sponsored by GlaxoSmithKline and targets healthy children who have completed routine immunizations. Participants are randomly assigned to receive three doses of the RTS,SAS01E vaccine on one of three schedules Day 1, Month 1, and Month 2 Day 1, Month 1, and Month 7 or Day 1, Month 2, and Month 7. The vaccine is given as an injection into the muscle. The study follows participants for up to 19 months to compare immune responses and safety across these different dosing schedules. During the study, children will have blood tests at multiple time points to measure antibodies against malaria and hepatitis B, along with monitoring for any side effects following vaccination. Researchers will track any adverse events, including serious ones, for up to 19 months after the first dose. Parents or guardians will complete diaries and attend follow-up visits to help monitor health and vaccine effects throughout the study period.

Researchers are studying pediatric cryptosporidiosis to better understand how this infection presents and progresses in children aged 6 to 59 months. The focus is on characterizing the clinical features and course of diarrhea caused by Cryptosporidium, a parasite common in certain regions. This observational study aims to gather detailed information on symptoms and outcomes in affected children. Participants are children with diarrhea due to Cryptosporidium infection confirmed by specific stool tests. The study observes children with varying durations of diarrheafrom acute to chronicand different nutritional statuses. The study follows children for up to 21 days, monitoring diarrhea severity, dehydration, and parasite presence without administering any treatment. During participation, children will be assessed at multiple time points including baseline, days 3, 7, 14, and up to day 21. Researchers will collect stool samples and evaluate dehydration severity, diarrhea resolution time, and parasite shedding. Additional factors like age, nutritional status, and breastfeeding history will be analyzed to understand their association with illness duration and severity. Participants will be followed closely to capture the natural course of infection and symptoms.