An observational study in Chagas Disease and Syphilis, sponsored by Hospital de Niños R. Gutierrez de Buenos Aires. Status unknown at 1 site in Argentina. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Hospital de Niños R. Gutierrez de Buenos Aires · Observational
Among 26 studies in Chagas Disease with a site in Argentina — 3 open to participants now, 4 under way, 2 of them phase 3. Chagas Disease · Argentina.
Among the 26 studies in Chagas Disease with a site in Argentina, this one is one of 5 that started in 2019, is one of 9 observational ones, and was the 20th registered.
73 studies on the registry are indexed under Chagas Disease; 5 are open to participants now.
Browse Chagas Disease studies →3 of the 26 studies in Chagas Disease with a site in Argentina are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Argentina, United States, Brazil and 1 more country
Laboratorio Elea Phoenix S.A. · Sites in Argentina
Bayer · Sites in Argentina, United States, Bolivia and 9 more countries
A study can be open while its sites in Argentina have not opened yet or have stopped. Only those recruiting at a site in Argentina →
Of the 3 Chagas Disease studies recruiting now, 1 (33%) set no upper age limit and 2 (67%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 1 Day to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 5 started in 2019.
This study's planned enrollment of 560 is above the median of 120 across 21 observational studies indexed under Chagas Disease.
Median enrollment 87 across the 17 interventional studies, 560 across the 9 observational. Of the 20 that completed or were terminated, 3 (15%) have results posted.
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12 of 26 have an industry lead sponsor. The 10 most frequent:
Hospital de Niños R. Gutierrez de Buenos Aires is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Hospital de Niños R. Gutierrez de Buenos Aires has 6 studies filed under Chagas Disease — fewer than ten, so there is no comparison to draw.
2 of the studies in Chagas Disease with a site in Argentina that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04024163Phase 3Insud PharmaProspective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease | 2027-08-30 |
| NCT06632600Novartis PharmaceuticalsA Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease. | 2027-07-22 |
Among the 26 studies in Chagas Disease with a site in Argentina, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Chagas disease and syphilis are considered a mayor public health problem worldwide. Both pathologies affect socio-economic vulnerable population and they are both transmitted congenitally, causing an alarming increasing number of infected newborns. The current diagnostic methods for these diseases are based on serology follow-up until 8 to 10 months from birth, which considering the population usually involved and their scarce resources, usually translates in loosing continuity in their controls and follow-up.
Chagas prevalence in pregnant women is 4% with an incidence of Congenital Chagas disease of 1500 annual cases. From those, only 1 third are diagnosed. In the investigators and other authors experience, the detection of DNA of Trypanosoma cruzi by PCR shows an elevation of parasitemia at birth, with a peak at the first month of life.
Syphilis is a re-emergent pathology, preventable and curable when diagnose is achieved early at the beginning of pregnancy.. The cost-effectiveness of performing screening for this infection is widely demonstrated, preventing high morbi-mortality for children when applied to pregnant women.
For both syphilis and Chagas diagnosis, there are some studies comparing PCR follow-up with conventional serology, but none were validated and there is still need to bring more evidence in order to modify current practice. The investigators propose a sequential study of PCR for Tryipanosoma cruzi and Treponema pallidum from birth, believing this will increase sensitivity of congenital Chagas and syphilis diagnose and improve follow-up of these patients.
Population of this study are children born from mother positive for syphilis or Chagas diseases, with congenital infection suspected and children with acquired syphilis.
They will be recruited at five centers from different geographical areas of Argentina
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Exclusion Criteria:
Implementation of Bio-molecular Techniques (PCR) for Early Diagnose of Congenital Syphilis and Chagas Diseases
Evaluate PCR sensitivity, specificity, PPV and NPP in diagnose of congenital syphilis and congenital Chagas diseases and compare it with current methods. The investigators will measure PCR titles during one year in each patient, and then compare results with serologies, in order to assess if PCR positivization and negativization occurs earlier than current methods. This may allow physicians to shorten time required for follow-up in these patients.
Time frame: 2 years
Implementation of Bio-molecular Techniques (PCR) as terapeutic response biomarker for Congenital Syphilis and Chagas Disease
Investigators will evaluate the utility of PCR as an early biomarker of terapeutic response and compare it to serology for T.pallidum and T. cruzi during and after treatment. This could prevent unnecessary prolonged treatments, and could also allow early diagnose for treatment failures.
Time frame: 2 years
Identification of different genotypes of T.pallidum in samples to create a database of T.pallidum genotypes
Identification of different genotypes of T.pallidum in samples taken from active skin lessions and blood samples, in order to create a data base of T.pallidum genotypes causing congenital syphilis and acquired syphilis
Time frame: 2 years
Started Jul 2019 (actual). Primary completion is estimated for Dec 2023, 53 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Hospital de Niños R. Gutierrez de Buenos Aires