Evidence map›Paper›PMID 31251812›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Pyronaridine-artesunate Efficacy and Safety in Uncomplicated Plasmodium falciparum Malaria in Areas of Artemisinin-resistant Falciparum in Viet Nam (2017-2018).

Phuc Quang Bui, Quang Hong Huynh, Duong Thanh Tran, Dong Thanh Le, Thieu Quang Nguyen, Hanh Van Truong, Nimol Khim, Benoit Witkowski, Dai Cong Tran, Maria Dorina Bustos and 2 more

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Efficacy, Safety and Tolerability of Pyronaridine-artesunate in Asymptomatic Malaria-infected Individuals: a Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  5. Trial
  6. Article
  7. Review
  8. Review
  9. Article
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  11. Review
  12. Article
  13. Article
  14. Journal of parasitic diseases : official organ of the Indian Society for Parasitology · 2023
    Article
  15. Review
  16. Clinical and In Vitro Resistance of Plasmodium falciparum to Artesunate-Amodiaquine in Cambodia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  17. Article
  18. Observational
  19. Article
  20. Liver Function Test Abnormalities in Experimental and ClinicalThe American journal of tropical medicine and hygiene · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 3 countries.

Phuc Quang BuiNational Institute of Malariology, Parasitology and Entomology, Hanoi, Vietnam.
Quang Hong HuynhInstitute of Malariology, Parasitology & Entomology, Quy Nhon, Vietnam.
Duong Thanh TranNational Institute of Malariology, Parasitology and Entomology, Hanoi, Vietnam.
Dong Thanh LeInstitute of Malariology, Parasitology & Entomology in Ho Chi Minh City, Vietnam.
Thieu Quang NguyenNational Institute of Malariology, Parasitology and Entomology, Hanoi, Vietnam.
Hanh Van TruongNational Institute of Malariology, Parasitology and Entomology, Hanoi, Vietnam.
Nimol KhimMalaria Molecular Epidemiology Unit, Pasteur Institute in Cambodia, Phnom Penh.
Benoit WitkowskiMalaria Molecular Epidemiology Unit, Pasteur Institute in Cambodia, Phnom Penh.
Dai Cong TranWorld Health Organization, Hanoi, Vietnam.
Maria Dorina BustosWorld Health Organization, Bangkok, Thailand.
Pascal RingwaldWorld Health Organization, Geneva, Switzerland.
Tinh Thi TaNational Institute of Malariology, Parasitology and Entomology, Hanoi, Vietnam.
National Institute of Malariology, Parasitology and Entomology · VNInstitut Pasteur du Cambodge · KHWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundMultidrug-resistant Plasmodium falciparum undermines the efficacy of currently deployed antimalarial therapies in southern Viet Nam.

methodsBetween May 2017 and December 2018, this prospective, open-label, single-arm, observational clinical trial, conducted in Binh Phuoc, Dak Nong, Gia Lai, Khanh Hoa, and Ninh Thuan provinces, evaluated the safety and efficacy of oral pyronaridine-artesunate once daily for 3 consecutive days in adults and children with microscopically confirmed P. falciparum malaria. Patients were treated as inpatients for Days 0-3, with follow-up visits on Days 7, 14, 21, 28, 35, and 42. The primary outcome was the proportion of polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 42.

resultsThe cumulative incidence of PCR-adjusted ACPR at Day 42 was 96.1% (95% confidence interval [CI] 91.4-98.2; Kaplan-Meier). In the per-protocol analysis, the proportion of patients with Day 42 PCR-adjusted ACPR was 96.1% (147/153; 95% CI 91.7-98.5). The proportion of patients with parasitemia at Day 3 was 24.0% (40/167; 95% CI 17.7-31.2). The prevalences of the Kelch13 (C580Y) mutation were: in Binh Phuoc, 97.7% (43/44); in Dak Nong, 96.2% (25/26); in Gia Lai, 57.8% (37/64); in Khanh Hoa, 66.6% (6/9); and in Ninh Thuan, 3.6% (1/28). The majority of artemisinin-resistant isolates also had increased plasmepsin2 copy number (75.9%; 85/112). There was 1 isolate (Binh Phuoc) that had Kelch13 (C580Y) plus increased plasmepsin2 and Pfmdr1 copy numbers. Asymptomatic transient increases in alanine transaminase and aspartate transaminase were observed at Day 7, resolving by Day 28.

conclusionsPyronaridine-artesunate can be used to diversify antimalarial therapy in areas of artemisinin-resistant P. falciparum in Viet Nam. CLINICAL TRIALS REGISTRATION: ACTRN12618001274268.

Indexed as

AntimalarialsArtemisininsMalaria, FalciparumAdultArtesunateChildDrug CombinationsHumansNaphthyridinesPlasmodium falciparumProspective StudiesVietnamAntimalarialsArtemisininsArtesunateDrug CombinationsNaphthyridinespyronaridineartemisinindrug resistancePlasmodium falciparumpyronaridine-artesunate

Identifiers

PMID31251812
OpenAlexW2954514631

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.