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Strongyloidiasis clinical trials

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NCT ID: NCT06368609 Not yet recruiting - Clinical trials for Strongyloides Stercoralis Infection

PRELIMINARY EVALUATION OF TWO RAPID DIAGNOSTIC TEST PROTOTYPES FOR STRONGYLOIDES STERCORALIS INFECTION

PROTOSS
Start date: April 2024
Phase: N/A
Study type: Interventional

Single center, no profit experimental study on sera available in the Tropica Biobank.

NCT ID: NCT06308705 Completed - Clinical trials for Strongyloides Stercoralis Infection

The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis

Start date: June 6, 2023
Phase: N/A
Study type: Interventional

This is a single-center interventional study with an IVD medical device. The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study. All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study. The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples. The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests.

NCT ID: NCT05868005 Recruiting - Hiv Clinical Trials

Delivering a Multi-disease Screening Tool to Migrant Populations

ISMiHealth
Start date: October 23, 2023
Phase: N/A
Study type: Interventional

Migrants' overall health status may be improved by increasing the detection of certain infectious diseases and other conditions for which effective care is available. This can be achieved through a systematic screening of these conditions using innovative and digital solutions implemented in routine health care. This study aims to evaluate the implementation of a screening programme for migrants at primary care level in two different settings of Spain (Catalonia and Andalusia) using an innovative digital and user-friendly software tool (ISMiHealth). In Catalonia, the ISMiHealth tool has already been integrated into the Electronic Patient Record (EPR) system (eCAP) as part of a pilot study in 2018; currently, the research team aims to validate the tool in a higher number of primary care centres in this area. Therefore, a pragmatic cluster randomised controlled trial will be conducted with two parallel groups, in which selected centres using the novel software ISMiHealth will be compared to others that follow the current routine practice. On the other hand, in Andalusia a pilot cluster randomised controlled trial will be carried out, where the ISMiHealth tool will be implemented in the EPR system (DIRAYA) to evaluate the preliminary effectiveness of the tool in other settings. The ISMiHealth software is a clinical decision support system that provides recommendations for primary healthcare professionals on screening for targeted conditions. It currently includes: 7 communicable diseases (Human immunodeficiency virus, Hepatitis B and C virus, Tuberculosis, Chagas diseases, strongyloidiasis and schistosomiasis) and one key health condition (female genital mutilation). Through routinely collected variables (country of birth, age, and sex), the software performs an individualised risk assessment and provides real-time prompts to healthcare professionals on screening for the selected health conditions. In any case, health professionals will be responsible for requesting screening tests and/or referrals to specialists.

NCT ID: NCT04999774 Completed - Strongyloidiasis Clinical Trials

Evaluation of Strongyloidiasis in Ecuador: a fieLd Laboratory Accuracy Study

ESTRELLA
Start date: September 6, 2021
Phase:
Study type: Observational

the World Health Organization (WHO) has recently committed to promote the control of strongyloidiasis within 2030 targets for STH control programmes. A specific target is to establish by 2030 an efficient strongyloidiasis control programme in school aged children (SAC), envisaging ivermectin preventive chemotherapy (PC) of SAC at risk of morbidity due to strongyloidiasis. The monitoring of such ambitious PC activity strictly requires appropriate diagnostic tools, but fundamental gaps exist in this field. Indeed, until now at the moment no consensus method for the diagnosis of S. stercoralis infection is recommended and the absence of a gold standard test limits capacity for effective diagnosis, surveillance and disease control. The aim of this project is to provide fundamental information on the performance and applicability of diagnostic methods for the assessment of S. stercoralis infection to inform the forthcoming WHO global strongyloidiasis control program to be implemented as a part of the WHO 2030 disease control targets. ESTRELLA is a cross-sectional study in an area of high prevalence of strongyloidiasis (San Lorenzo, Esmeraldas, Ecuador). The study will have a school-based approach, and each enrolled SAC will be asked to supply fecal and blood samples for testing with different methods for the diagnosis of S. stercoralis infection.

NCT ID: NCT04848688 Completed - Clinical trials for Strongyloides Stercoralis Infection

Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

StrongMoxi_KH
Start date: February 5, 2022
Phase: Phase 3
Study type: Interventional

The study is an extension to the study StrongMoxi NCT04056325 and entails modifications based on the outcome of NCT04056325 part A. The study is a phase 3, double-blinded and randomized clinical trial conducted in Cambodia. It aims at providing evidence on efficacy, safety and pharmacokinetic measures of 8 mg of moxidectin compared to 200 μg/kg ivermectin in adults infected with S. stercoralis. The efficacy of the treatment will be assessed by collecting three stool samples once per-treatment and once 21-28 days post-treatment. The stool samples will be analyzed by a quantitative duplicate Baermann assay.

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: NCT04709848 Not yet recruiting - Strongyloidiasis Clinical Trials

Strongyloides Stercoralis in Bone Marrow Transplant Recipients in the UK

SSSSBMTUK
Start date: February 2021
Phase:
Study type: Observational

Strongyloidiasis is a worm infection which affects more than 100 million people, mostly in Africa, Asia and Latin America, and can cause severe illness in people with reduced immunity. In the UK, the number of people with Strongyloides is not known. At Imperial College Healthcare NHS Trust (ICHNT) , screening for Stongyloides has recently been introduced as a standard-of-care for all patients undergoing BMT. In this study, investigators will perform two cross-sectional surveys and report the prevalence of Strongyloides in BMT recipients at ICHNT , as well as comparing clinical outcomes before/after the introduction of routine testing.

NCT ID: NCT04056325 Enrolling by invitation - Clinical trials for Strongyloides Stercoralis Infection

Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

StrongMoxi
Start date: November 27, 2019
Phase: Phase 2
Study type: Interventional

This study is a phase 2, blinded and randomized clinical trial. The phase 2a trial is single blinded and conducted in Lao, while the phase 2b trial is double-blinded and conducted in Lao and Cambodia. The study aims at providing evidence on effective doses and safety of moxidectin in adults against infection with S. stercoralis in Laos (trial 2a) and efficacy and safety of moxidectin compared to ivermectin in adults against infection with S. stercoralis in Laos and Cambodia (trial 2b). The efficacy of the treatment will be assessed by collecting three stool samples once pre-treatment and once 21 days post-treatment. The stool samples will be analyzed by a quantitative Baermann assay.

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: NCT03605758 Terminated - Strongyloidiasis Clinical Trials

Treatment of Strongyloides Infection

TSSI
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the serologic response in patients with S. stercoralis infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given 2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two consecutive days.