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Trichuriasis clinical trials

View clinical trials related to Trichuriasis.

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NCT ID: NCT06188715 Not yet recruiting - Hookworm Infections Clinical Trials

Efficacy and Safety of MOX/ALB Co-administration in SAC

Moxiped
Start date: March 2024
Phase: Phase 3
Study type: Interventional

This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC. As measure of efficacy of the treatment the cure rate (percentage of eggpositive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

NCT ID: NCT06184399 Not yet recruiting - Hookworm Infections Clinical Trials

Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC

Iverped
Start date: April 2024
Phase: Phase 2
Study type: Interventional

This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed ODTs and the standard ivermectin tablets (Stromectol®) will be compared in this age group. As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

NCT ID: NCT06037876 Completed - Trichuriasis Clinical Trials

Efficacy of Ivermectin-albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura

FACEITeffic
Start date: October 9, 2023
Phase: Phase 3
Study type: Interventional

The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years. The main questions it aims to answer are: - Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against T. trichiura infections in children aged 6-12 years in Uganda? - Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against co-infecting soil-transmitted helminth infections such as Ascaris lumbricoides and hookworm in children aged 6-12 years in Uganda? - Is single oral dose combined ivermectin-albendazole as tolerable and safe as albendazole monotherapy in children aged 6-12 years in Uganda? Participants will be asked to provide two stool samples at baseline that will be subjected to microscopic analysis using the Kato-Katz thick smear technique for detection of soil-transmitted helminth eggs. T. trichiura-infected participants will be: - clinically examined for general health, anthropometric parameters including height and weight as well as temperature - randomly assigned to either receive one single oral dose of combined ivermectin and albendazole or albendazole monotherapy - checked for any potential adverse events and will undergo a brief questionnaire on specific symptoms 3h after drug administration - asked to provide another two stool samples to be microscopically examined for helminth eggs 14-21 days post-treatment Researchers will compare individuals treated with ivermectin-albendazole and albendazole alone to see if the proportion of T. trichiura egg-negative individuals and/or reduction in egg counts differs between these two groups 14-21 days after treatment.

NCT ID: NCT05914363 Recruiting - Hookworm Infection Clinical Trials

Evaluating Impact of Improved Floors on Health

SABABU
Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention study is to learn about the impact of household flooring on health in rural Kenya, and test whether providing an improved (cement stabilised, washable) floor improves the health of children and their care providers. The main questions the study aims to answer are: - What is the effect of providing a sealed, washable floor on the prevalence of infections that cause diarrhoea, intestinal worms and sand flea infections? - To what extent does the intervention reduce contamination of floors with pathogens within the home? - What is its effect of the intervention on the wellbeing of caregivers and children? - Over the course of a year, do the new floors remain undamaged, with no cracks? - Do participants living with the new floors, and the masons that helped to install the floors, like them and feel they are practical and affordable? The study will involve a trial, where half of the recruited households will be randomly chosen to receive the new floor in addition to some support on how to care for the floor and keep it clean. The other half of households will not receive anything at first, but at the end of the research project will also receive a new floor. Before the new floors are installed, the investigators will make several assessments in all study households. These will include a survey to measure household characteristics; a stool survey, to measure how many people are infected with diarrhoea-causing microorganisms and parasitic worms; a jigger flea examination among children; wellbeing assessments among children and caregivers; and soil sampling to identify microorganisms on the floor of the household. When households receive the new floor, participants will have to move out of their house for up to 7 days during installation. Participants will also be asked to attend some group meetings to discuss ways of taking care of the floor and keeping it clean. Assessments will be repeated 12 months after the floor has been delivered, and additional interviews will be held with a small number of randomly selected participants. Throughout the 12 months following delivery of the intervention, investigators will make unannounced visits to households to check the condition of the floor. Participants will also be offered treatment for parasitic worm infections after assessments have been completed at the start and end of the project.

NCT ID: NCT05706116 Not yet recruiting - Trichuriasis Clinical Trials

Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults

Start date: July 1, 2024
Phase: Phase 1
Study type: Interventional

A Controlled Human Infection Model (CHIM) is being developed to provide early proof-of-concept that experimental infection with the intestinal nematode, Trichuris trichiura, is feasible and safe. The proposed model consists of enrolling consenting, healthy, trichuriasis-naïve adults and challenging them with the investigational product, Trichuris trichiura Egg Inoculum, to assess their ability to result in detectable infection. The proposed study will be a feasibility study that will consist of administering different doses of the Trichuris trichiura Egg Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of T. trichiura eggs) that is safe, well-tolerated and results in consistent infection.

NCT ID: NCT05372068 Recruiting - Diarrhea Clinical Trials

Cement flooRs AnD chiLd hEalth (CRADLE)

Start date: September 24, 2023
Phase: N/A
Study type: Interventional

This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudinal follow-up measurements at birth and when children are ages 3, 6, 12, 18, and 24 months.

NCT ID: NCT05017194 Completed - Hookworm Infections Clinical Trials

Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm

EMODEP_PEMBA
Start date: August 2, 2021
Phase: Phase 2
Study type: Interventional

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.

NCT ID: NCT04726969 Completed - Hookworm Infections Clinical Trials

Efficacy and Safety of MOX/ALB Co-administration

Start date: June 15, 2021
Phase: Phase 3
Study type: Interventional

This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in adolescents and adults (12-60 years) in Côte d'Ivoire. One arm of patients will be treated with albendazole-ivermectin. As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

NCT ID: NCT04713787 Not yet recruiting - Trichuriasis Clinical Trials

A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method.

NCT ID: NCT04700423 Completed - Hookworm Infections Clinical Trials

Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration

Start date: March 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura. The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment. This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).