Asset Publisher

Research & Innovation Programmes
Research

STOP

Towards the interruption of transmission of soil-transmitted helminths

Photo: CDC
Duration
Oct 01, 2018 - Sep 01, 2022
Coordinator
Jose Muñoz
Funded by
EDCTP (European & Developing Countries Clinical Trial Partnership)
Website
http://stoptheworm.org/

The current World Health Organization (WHO) control strategy for Soil-Transmitted Helminths (STH) emphasizes morbidity control through mass drug administration with albendazole or mebendazole, mainly targeting preschool and school-aged children in endemic areas. Increasing concerns have been raised about the success of these monotherapy strategies: 1) whilst albendazole is still efficacious against Ascaris lumbricoides and hookworm, a low and decreasing efficacy against Trichuris trichiura is observed, and none of these strategies is effective against Strongyloides stercoralis; 2) the use of widespread monotherapy could lead to the emergence of albendazole resistance. Modeling studies predict a huge impact on years lived with disability and economic productivity, if these strategies remain unchanged.

Ivermectin has shown an enhanced activity against T. trichiura when combined with albendazole, and is considered the drug of choice against strongyloidiasis and other parasitic infections. Adding ivermectin to albendazole would increase efficacy of the interventions, and decrease the possibility of emergence of resistance, as recently suggested by WHO.

Objectives

The main goal of the STOP project is to develop and test the safety and efficacy of a fixed-dose co-formulation of ivermectin and albendazole against STHs, as a single dose and a three-dose regimen, compared to a single dose of albendazole in a phase III clinical trial.

The project will include capacity building and networking activities. Besides microscopy-based procedures, parasite DNA detecting techniques (PCR) will be used and validated as markers of treatment response. Modeling studies will evaluate the potential impact on transmission and economic benefits of the new treatment regimen. The scientific results will be presented to the scientific community, local governments and other implementation actors and stakeholders.

Previous collaborations of members of this consortium developed and tested the safety of a fixed high dose of ivermectin, as a first step towards the fixed-dose combination with albendazole. This consortium integrates complementary expertise in drug development, manufacture and regulatory processes with a pharmaceutical company, with expertise in parasitology, veterinary, epidemiology and public health. This places us in a unique situation to progress to the regulatory approval and market authorization by health authorities (WHO and EMA) and to advocate for policy changes among the different stakeholders, while ensuring a continuous supply of ivermectin for the control of several Neglected Tropical Diseases.

The proposed fixed-dose formulation represents a promising tool to alleviate the burden of STH morbidity, help stop STH transmission and ultimately contribute to the achievement of the SDGs.

Total funding

4,899,487.64€

Our Team

Principal investigator

  • Jose Muñoz Gutiérrez
    Jose Muñoz Gutiérrez

ISGlobal team

Other projects

See Past Projects

COMBACTE

Combating Bacterial Resistance In Europe

GAMA

Development of Novel Gastrointestinal Biomarkers for Use in HIV Incidence Determination in a Sub-Saharan African Setting

COMBACTE-CARE

Combatting Bacterial Resistance in Europe - Carbapenem Resistance

MAMAH

Improving Maternal and Infant Health by reducing malaria risks in African women: evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women

INTE-AFRICA

Integrating and decentralizing diabetes and hypertension services in Africa

ICARIA

Improving Care through Azithromycin Research for Infants in Africa

PreFIT

Predicting the Future: Incipient Tuberculosis

ANTICOV

Large Clinical Trial in Africa on the Treatment of Mild Cases of COVID-19

Stool4TB

Evaluating a new stool based qPCR for diagnosis of tuberculosis in children and people living with HIV

TB-RECONNECT

Reconnecting Transmission to Global Tuberculosis Control by Mapping Pathogen Transmission Events to Host Infection Status

SToolNIH

Quantifiable stool-based TB PCR to Improve Diagnostics and Treatment Monitoring

END-VOC

ENDing COVID-19 Variants Of concern through Cohort studies (END-VOC)

TwinAir

Digital Twins Enabled Indoor Air Quality Management for Healthy Living

ENDÈMIC

Community knowledge generation through scientific culture, urban ecology and art

EpiGen

Building Scalable Pathogen Genomic Epidemiology in Ethiopia

Hepatitis C Free Baleares

Eliminating hepatitis C on the Balearic Islands (Mallorca, Menorca and Ibiza): a study in governmental and non-governmental addiction service centres, a mobile methadone unit and a prison to test and link people who use drugs to HCV care.

FLAVOBAC

Nuevas moléculas de oro coordinadas con flavonoides contra bacterias patógenas multirresistentes prioritarias

NHEPACHA

New Tools for the Diagnosis and Evaluation of Chagas Disease

RTS,S Vaccine Immunology Study

Study of immune correlates of protection against malaria after vaccination with RTS,S/AS01E: a comprehensive immunological arm of a Phase III double-blind, randomized, controlled multi-center trial

Euroleish.net

Control of Leishmaniasis. From bench to bedside and community

GREPIMER

Grup de recerca en patología importada i malaties emergents i re-emergents

TESEO

New chemotherapy regimens and biomarkers for Chagas Disease

ASINTMAL

Unravelling Disease Tolerance and Host Resistance in Afebrile 'P. falciparum' Infections: a Prospective Study in Mozambican Adults

ADAM

Malaria mass and focal drug administration to advance malaria elimination in Mozambique: accelerating programmatic implementation and policy translation

MULTIPLY

MULTIple doses of IPTi Proposal: a Lifesaving high Yield intervention

Science4Pandemics

Citizens engagement digital platform for collective intelligence in pandemics

HIDDENVIVAX

Novel organ-on-a-chip technology to study extracellular vesicles-mediated cryptic infections in Plasmodium vivax malaria

MalTransc

Transcriptional regulation of adaptation and developmental decisions in malaria parasites: from epigenetic variation to directed transcriptional responses

BOHEMIA

Broad One Health Endectocide-based Malaria Intervention in Africa

RESPONSE

Mechanisms of the transcriptional responses to changes in the environment in the malaria parasite Plasmodium falciparum

VivaxEVTalk

Extracellular Vesicles as Intercellular Communicators and Biomarkers of Cryptic Erythrocytic Infections in Plasmodium vivax malaria

VaMonoS

Unravelling the heterogoneity and function of monocytes in vaccination and immunity to malaria

CLIMSOCTRYPBOL

Insight on climate and social participatory research for integral management of vectorborne zoonosis caused by Trypanosoma cruzi and Leishmania spp. in the Bolivian Gran Chaco.

SexMal

Social affairs and sex in P. falciparum: implications for malaria elimination

MENA Migrant Health

Transforming data collection and surveillance to drive migrant health research, care and policy

MESA

Sharing knowledge and catalyzing research towards a malaria-free world

GenMoz

P. falciparum genomic intelligence in Mozambique

SMART

Identifying Severe Malaria with a new Aptamer-based Rapid diagnostic Test