Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2017
Fixed-Dose Artesunate-Amodiaquine Combination vs Chloroquine for Treatment of Uncomplicated Blood Stage P. vivax Infection in the Brazilian Amazon: An Open-Label Randomized, Controlled Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01378286 (A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam), which is not on this map. Cited by 17 papers, 5 of them syntheses that pooled 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.
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.
A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria
Who cites it
17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- The cardiovascular effects of amodiaquine and structurally related antimalarials: An individual patient data meta-analysis.PLoS medicine · 2021Pooled it
- Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data.PLoS medicine · 2020Pooled it
- Assessment of Chloroquine and Hydroxychloroquine Safety Profiles: A Systematic Review and Meta-Analysis.Frontiers in pharmacology · 2020Pooled it
- Pooled it
- The effect of chloroquine dose and primaquine on Plasmodium vivax recurrence: a WorldWide Antimalarial Resistance Network systematic review and individual patient pooled meta-analysis.The Lancet. Infectious diseases · 2018Pooled it
- Monitoring the Efficacy of Chloroquine-Primaquine Therapy for Uncomplicated Plasmodium vivax Malaria in the Main Transmission Hot Spot of Brazil.Antimicrobial agents and chemotherapy · 2019Trial
- The Landscape of Malaria in a Five-Decade Institution in the State of Amazonas: Historical Trends, Scientific Contributions, and Research Priorities.Revista da Sociedade Brasileira de Medicina Tropical · 2026Review
- Short-Time Recurrences ofInternational journal of environmental research and public health · 2021Article
- Monitoring Plasmodium vivax resistance to antimalarials: Persisting challenges and future directions.International journal for parasitology. Drugs and drug resistance · 2021Review
- An Ultra-Sensitive Technique: UsingPathogens (Basel, Switzerland) · 2020Article
- Influence ofAntimicrobial agents and chemotherapy · 2020Article
- Assessment of Hydroxychloroquine and Chloroquine Safety Profiles: A Systematic Review and Meta-Analysis.medRxiv : the preprint server for health sciences · 2020Article
- Malaria and tuberculosis as diseases of neglected populations: state of the art in chemotherapy and advances in the search for new drugs.Memorias do Instituto Oswaldo Cruz · 2020Review
- Chloroquine resistance is associated to multi-copy pvcrt-o gene in Plasmodium vivax malaria in the Brazilian Amazon.Malaria journal · 2018Article
- SLCO1A2, SLCO1B1 and SLCO2B1 polymorphisms influences chloroquine and primaquine treatment in Plasmodium vivax malaria.Pharmacogenomics · 2017Article
- Measuring ex vivo drug susceptibility in Plasmodium vivax isolates from Cambodia.Malaria journal · 2017Article
- Article
Corrections and comments
- Erratum issuedErratum.2017
Authors and funding
14 authors at 8 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite increasing evidence of the development of Plasmodium vivax chloroquine (CQ) resistance, there have been no trials comparing its efficacy with that of artemisinin-based combination therapies (ACTs) in Latin America.
methodsThis randomized controlled trial compared the antischizontocidal efficacy and safety of a 3-day supervised treatment of the fixed-dose combination artesunate-amodiaquine Winthrop
resultsFrom 2012 to 2013, 380 patients were enrolled. In the per-protocol (PP) analysis, adjusted-ACPR was achieved in 100% (165/165) and 93.6% (161/172) of patients in the ASAQ and CQ arm (difference 6.4%, 95% CI 2.7%; 10.1%) at day 28 and in 97.4% (151/155) and 77.7% (129/166), respectively (difference 19.7%, 95% CI 12.9%; 26.5%), at day 42. Apart from ITT D28 assessment, superiority of ASAQ on ACPR was demonstrated. ASAQ presented faster clearance of parasitaemia and fever. Based on CQ blood level measurements, CQ resistance prevalence was estimated at 11.5% (95% CI: 7.5-17.3) up to day 42. At least one emergent adverse event (AE) was recorded for 79/190 (41x6%) in the ASAQ group and for 85/190 (44x7%) in the CQ group. Both treatments had similar safety profiles.
conclusionsASAQ exhibited high efficacy against CQ resistant P. vivax and is an adequate alternative in the study area. Studies with an efficacious comparator, longer follow-up and genotype-adjustment can improve CQR characterization. CLINICAL TRIALS REGISTRATION: NCT01378286.
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Registered trials
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.