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NCT04084379
Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases
trial in Chagas Disease in 560 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | Hospital de Niños R. Gutierrez de Buenos Aires |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 560 |
| Start date | 1 July 2019 |
| Primary completion | 30 December 2023 |
| Estimated completion | 1 September 2024 |
| Sites | 1 location across Argentina |
Conditions studied
- Chagas Disease — all drugs for Chagas Disease →
- Syphilis — all drugs for Syphilis →
Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Who can join
Adults 1 Day to 18, any sex, with Chagas Disease or Syphilis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Congenital syphilis in Argentina: Experience in a pediatric hospital.
Garcia LN, Destito Solján A, Moroni S, Falk N, et al · · 2021 · cited 8× · PMID 33406082 · DOI 10.1371/journal.pntd.0009010
Verify or expand the search:
- PubMed search for NCT04084379
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chagas Disease
Currently open trials in the same condition.
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- NCT04897516 — Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease · Phase 3 · recruiting
- NCT04984265 — SBRT in Chagas Disease Ventricular Tachycardia · Phase 1, PHASE2 · active not recruiting
- NCT04024163 — Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease · Phase 3 · active not recruiting
Other Hospital de Niños R. Gutierrez de Buenos Aires trials
Trials by the same sponsor.
- NCT06877351 — Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis. · Phase 3 · active not recruiting
- NCT05630898 — Congenital Cytomegalovirus: Prevalence in Buenos Aires City (cCMV Prevalence) · unknown
- NCT05541172 — Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism · unknown
- NCT04455425 — Acquired Syphlis by Non Sexual Contact · completed
- NCT04137601 — Congenital Syphilis Prospective Cohort With Retrospective Evaluation · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04084379 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Niños R. Gutierrez de Buenos Aires
- Last refreshed: 1 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04084379.
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