Who is sponsoring NCT04897919?

NCT04897919 is sponsored by Bandim Health Project.

What drugs are being tested in NCT04897919?

Interventions in NCT04897919: Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet, Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet.

What condition does NCT04897919 study?

NCT04897919 studies Malaria, Effectiveness.

Is NCT04897919 still recruiting?

NCT04897919 is currently completed. Last updated 12 April 2022.

Last reviewed 2022-04-12 · How we verify

NCT04897919

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effectiveness and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for Treating Malaria

Completed Phase 4 Last updated 12 April 2022

What this trial tests

Phase 4 trial testing Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet in Malaria in 474 participants. Completed in 1 December 2018.

Timeline

1 August 2015

Primary endpoint
1 October 2017

1 December 2018

Quick facts

Lead sponsor	Bandim Health Project
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	474
Start date	1 August 2015
Primary completion	1 October 2017
Estimated completion	1 December 2018
Sites	1 location across Guinea-Bissau

Drugs / interventions tested

Dihydroartemisinin-piperaquine 160 mg/20 mg Oral Tablet — full drug profile →
Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet — full drug profile →

Conditions studied

Malaria — all drugs for Malaria →
Effectiveness — all drugs for Effectiveness →

Sponsor

Bandim Health Project — full company profile →

Who can join

6 Months and older, any sex, with Malaria or Effectiveness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: to measure the effectiveness and safety of (artemether-lumefantrine) AL and (dihydroartemisinin-piperaquine) DP in patients (\> 6 months) suffering from uncomplicated P. falciparum malaria. Patients coming to Bandim Health Center will, if accepting, be randomised to study-arm. Medication will be provided and first dose given. Patients will be followed-up on day 7, 14, 28, and 42 with clinical evaluation, malaria film and filter-paper blood-sample for polumerase chain reaction (PCR) on re-appearing parasites. On day 21 and 35 a telephone-interview will be performed. Primary out-come: adequate clinical and parasitological response rate on day 42. Secondary out-comes: safety, re-infection vs recrudescence, and haemoglobin on day 42.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Malaria

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Other Bandim Health Project trials

Trials by the same sponsor.

NCT06266754 — The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau · Phase 4 · unknown
NCT05591339 — Diabetes Diagnosis, Management, Prevention and Education in Guinea-Bissau · Phase 4 · active not recruiting
NCT04899765 — Measles and BCG Vaccines for Mother and Child · Phase 4 · recruiting
NCT04542330 — Using BCG to Protect Senior Citizens During the COVID-19 Pandemic · Phase 3 · completed
NCT04445428 — OPV as Potential Protection Against COVID-19 · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04897919 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bandim Health Project
Last refreshed: 12 April 2022

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/NCT04897919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing