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NCT03172221: HSRDT MiP
Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women
trial testing HS-RDT in Plasmodium Falciparum in 880 participants. Completed in 31 January 2018.
31 January 2018
Quick facts
| Lead sponsor | Foundation for Innovative New Diagnostics, Switzerland |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 880 |
| Start date | 25 July 2017 |
| Primary completion | 31 January 2018 |
| Estimated completion | 31 January 2018 |
| Sites | 2 locations across Colombia |
Drugs / interventions tested
- HS-RDT
Conditions studied
- Plasmodium Falciparum — all drugs for Plasmodium Falciparum →
- Pregnancy Malaria — all drugs for Pregnancy Malaria →
- Diagnoses Disease — all drugs for Diagnoses Disease →
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Who can join
15 and older, female only, with Plasmodium Falciparum or Pregnancy Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs \[loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)\], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of highly sensitive diagnostic tools for the detection of P. falciparum in pregnant women attending antenatal care visits in Colombia.
Vásquez AM, Vélez G, Medina A, Serra-Casas E, et al · · 2020 · cited 17× · PMID 32736543 · DOI 10.1186/s12884-020-03114-4
Verify or expand the search:
- PubMed search for NCT03172221
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Plasmodium Falciparum
Currently open trials in the same condition.
- NCT06923592 — Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar · Phase 3 · recruiting
Other Foundation for Innovative New Diagnostics, Switzerland trials
Trials by the same sponsor.
- NCT06213051 — Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection · unknown
- NCT05944731 — Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya. · NA · unknown
- NCT06118749 — Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study · terminated
- NCT05944718 — Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa · NA · completed
- NCT06170515 — BGM and HbA1c POC Device Evaluation · NA · unknown
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 NCT03172221 (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 Foundation for Innovative New Diagnostics, Switzerland
- Last refreshed: 30 November 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/NCT03172221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing