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Filariasis clinical trials

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NCT ID: NCT05084560 Terminated - Onchocerciasis Clinical Trials

Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug

AWOL
Start date: December 10, 2021
Phase: Phase 1
Study type: Interventional

Lymphatic filariasis and onchocerciasis are a group of neglected tropical diseases caused by the transmission of worm larvae (microfilaria) by biting insects. Once a human is infected, the larvae mature into adult worms that release huge numbers of larvae into the lymphatics for 5-15 years. The larvae cause tissue damage resulting in the disabling diseases of elephantiasis (gross leg and scrotal swelling) and river blindness. These diseases affect 160 million people and are acknowledged major public health problems in the tropics. Current treatments mainly target the larvae but not the adult worms that live for years, meaning that repeated courses of treatment over many years are needed. These repeated courses are usually delivered at population level in the form of mass drug administration programmes. For the adult worms to be able to grow, reproduce and infect more humans they are dependent on a bacterium which lives inside them. This bacterium (Wolbachia) is not naturally found in humans. Some drugs are able to target Wolbachia, however they are unsuitable for mass drug administration programmes because they have to be given for 4-6 weeks and cannot be used in children or pregnant women. AWZ1066S is a novel drug developed in Liverpool that has been shown in experimental models to target Wolbachia and indirectly kill the adult parasitic worms after a 7 day course. After extensive safety testing in animals we are conducting a Phase 1, first in human study, to assess the safety, tolerability and pharmacokinetics of ascending single and multiple oral doses of AWZ1066S in healthy volunteers. The study is a single centre study, will last approximately 1 year and will take place in a dedicated Phase 1 trial unit. Depending on which group they are enrolled into, participants will take either one dose, two doses or seven doses and their involvement will last between 38 and 45 days. Participants will be closely monitored for adverse effects.

NCT ID: NCT04920292 Completed - Filariasis Clinical Trials

PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets

HELP-OFZ
Start date: April 21, 2022
Phase: Phase 1
Study type: Interventional

The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.

NCT ID: NCT04844905 Recruiting - Malaria,Falciparum Clinical Trials

Adjunctive Ivermectin Mass Drug Administration for Malaria Control

MATAMAL
Start date: May 3, 2021
Phase: Phase 3
Study type: Interventional

This is a cluster-randomized placebo-controlled clinical trial to evaluate the additive benefit of Ivermectin (IVM) (or Placebo) mass drug administration (MDA) to dihydroartemisinin-piperaquine (DP) MDA for malaria control in a moderate to low malaria-endemic setting as an adjunctive strategy to existing programmatic malaria control measures. The regime of DP and IVM will target both human reservoirs of Plasmodium falciparum and the Anopheles gambiae vector respectively, with the aim of interrupting transmission. The trial will be conducted on the Bijagos Archipelago, where islands (clusters) will be randomised to receive seasonal DP and IVM or DP and Placebo MDA. The primary outcome will be the prevalence of infection with Plasmodium falciparum in all age groups detected by nucleic acid amplification testing during the peak malaria transmission season after two years of intervention.

NCT ID: NCT04410406 Active, not recruiting - Clinical trials for Lymphatic Filariasis

Moxidectin for LF, Cote d'Ivoire (DOLF)

Start date: August 20, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether moxidectin (Mox) will be more effective than ivermectin (IVM) when used in single-dose combination therapies for lymphatic filariasis (LF).

NCT ID: NCT04311671 Active, not recruiting - Onchocerciasis Clinical Trials

Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole

Start date: May 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.

NCT ID: NCT04258670 Active, not recruiting - Clinical trials for Lymphatic Filariasis

Spontaneous Antigenemia in Loiasis

Start date: January 23, 2020
Phase:
Study type: Observational [Patient Registry]

This prospective study will enroll and follow 60 loiasis patients with high worm burden to monitor the spontaneous release of filarial antigen in peripheral blood. This study will define the cross-reactive antigen profile of persons with spontaneous loiasis antigenemia, and determine whether it varies with time.

NCT ID: NCT04124250 Recruiting - Clinical trials for Lymphatic Filariasis Elimination by Mass Drug Administration

East New Britain Province Monitoring & Evaluation

ENBP M&E
Start date: September 17, 2019
Phase:
Study type: Observational

While tremendous progress towards elimination of lymphatic filariasis (LF) has been made in the 20 years since the 1997 Fiftieth World Health Assembly, it is unlikely the goal of eliminating LF as a public health problem by 2020 will be achieved. As of 2016, it was estimated that 856 million people are still living in areas with ongoing transmission of LF and require mass drug administration (MDA) [1]. Of the 52 countries that remain endemic and require MDA, 22 (42%) have not started MDA in all endemic implementation units (IUs) [1]. In addition, several countries have found that, despite completing the required number of treatment rounds, the response to the present MDA regimen has been suboptimal in some IUs, requiring additional rounds of MDA.

NCT ID: NCT03683745 Completed - Leprosy Clinical Trials

Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia

Start date: June 14, 2018
Phase:
Study type: Observational

Appropriate targeting of interventions for neglected tropical diseases (NTDs) that require innovative and intensified disease management (IDM) requires accurate data on the distribution of these diseases within endemic countries. In most instances however, existing case register data generated through national health management information systems or during programmatic activities do not provide an accurate representation of the true burden of IDM NTDs. This study will pilot a cluster randomized screening and confirmation survey to estimate the burden of IDM NTDs characterised by skin conditions associated with long-term disfigurement and disability. These include: leprosy, Buruli ulcer, yaws and lymphoedema and hydrocele resulting from lymphatic filariasis. The survey is being conducted in one county in Liberia. The protocol involves community-level screening by community health volunteers trained to use photo-based visual aids to recognise changes in the skin that broadly indicates patent infection. All suspected cases will be verified in their homes by local and national experts trained in the diagnosis of skin-presenting NTDs. The survey will generate accurate district-level prevalence estimates of leprosy, yaws, Buruli ulcer and lymphatic filariasis-associated lymphoedema and hydrocele and quantify the total costs and cost per case detected. In addition, results from this protocol will be compared with routinely collected case register data, to better understand how health system records reflect the true disease situation on the ground and quantify unmet need.

NCT ID: NCT03676140 Completed - Scabies Clinical Trials

Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately. Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.

NCT ID: NCT03664063 Completed - Trauma Clinical Trials

PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

Start date: September 1, 2018
Phase: Phase 2
Study type: Interventional

This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.