Trial reportPLoS neglected tropical diseases2014
Population pharmacokinetic study of benznidazole in pediatric Chagas disease suggests efficacy despite lower plasma concentrations than in adults.
Trial report in PLoS neglected tropical diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00699387 (Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease), which is not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.
What it found
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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.
Population Pharmacokinetics Study of Benznidazole in Children With Chagas Disease
Who cites it
48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 107 citations in OpenAlex.
- Interventions to treat cutaneous leishmaniasis in children: A systematic review.PLoS neglected tropical diseases · 2018Pooled it
- Safety Profile of Benznidazole in the Treatment of Chronic Chagas Disease: Experience of a Referral Centre and Systematic Literature Review with Meta-Analysis.Drug safety · 2018Pooled it
- Lack of Clinical Pharmacokinetic Studies to Optimize the Treatment of Neglected Tropical Diseases: A Systematic Review.Clinical pharmacokinetics · 2017Pooled it
- Population pharmacokinetic-pharmacodynamic analysis of benznidazole monotherapy and combination therapy with fosravuconazole in chronic Chagas disease (BENDITA).PLoS neglected tropical diseases · 2025Trial
- Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease.PLoS neglected tropical diseases · 2019Trial
- Dried Blood Spot Technique-Based Liquid Chromatography-Tandem Mass Spectrometry Method as a Simple Alternative for Benznidazole Pharmacokinetic Assessment.Antimicrobial agents and chemotherapy · 2018Trial
- Population pharmacokinetics of benznidazole in adult patients with Chagas disease.Antimicrobial agents and chemotherapy · 2015Trial
- Target product profile for the development of pediatric formulations of new drugs for the treatment of children with T. cruzi infection.PLoS neglected tropical diseases · 2026Review
- Article
- Cost-effectiveness analysis of screening for congenital Chagas disease in a non-endemic area.Nature communications · 2025Article
- Pharmacokinetic-pharmacodynamic modeling of benznidazole and its antitrypanosomal activity in a murine model of chronic Chagas disease.PLoS neglected tropical diseases · 2025Article
- System-based insights into parasitological and clinical treatment failure in Chagas disease.mSystems · 2025Review
- Congenital Chagas disease: A cohort study to assess molecular diagnostic methods at the Chagas disease national reference center of Argentina.PLoS neglected tropical diseases · 2025Article
- Pharmacokinetics of two pharmaceutical presentations of benznidazole in adult Trypanosoma cruzi infected population.Memorias do Instituto Oswaldo Cruz · 2025Article
- The carbonic anhydrase enzymes as new targets for the management of neglected tropical diseases.Archiv der Pharmazie · 2025Review
- Adverse events associated with benznidazole treatment for Chagas disease in children and adults.British journal of clinical pharmacology · 2024Article
- Development of a Colorimetric Loop-Mediated Isothermal Amplification Assay for the Detection ofDiagnostics (Basel, Switzerland) · 2024Article
- Nanomedicines against Chagas disease: a critical review.Beilstein journal of nanotechnology · 2024Review
- Population pharmacokinetics of benznidazole in neonates, infants and children using a new pediatric formulation.PLoS neglected tropical diseases · 2023Article
- Further Investigations of Nitroheterocyclic Compounds as Potential Antikinetoplastid Drug Candidates.Biomolecules · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionChagas disease, caused by the parasite Trypanosoma cruzi, can lead to long term cardiac morbidity. Treatment of children with benznidazole is effective, but no pediatric pharmacokinetics data are available and clinical pharmacology information on the drug is scarce. PATIENTS AND
methodsProspective population pharmacokinetic (PK) cohort study in children 2-12 years old with Chagas disease treated with oral benznidazole 5-8 mg/kg/day BID for 60 days. (clinicaltrials.gov #NCT00699387).
resultsForty children were enrolled in the study. Mean age was 7.3 years. A total of 117 samples were obtained from 38 patients for PK analysis. A one compartment model best fit the data. Weight-corrected clearance rate (CL/F) showed a good correlation with age, with younger patients having a significantly higher CL/F than older children and adults. Simulated median steady-state benznidazole concentrations, based on model parameters, were lower for children in our study than for adults and lowest for children under 7 years of age. Treatment was efficacious in the 37 patients who completed the treatment course, and well tolerated, with few, and mild, adverse drug reactions (ADRs). DISCUSSION: Observed benznidazole plasma concentrations in children were markedly lower than those previously reported in adults (treated with comparable mg/kg doses), possibly due to a higher CL/F in smaller children. These lower blood concentrations were nevertheless associated to a high therapeutic response in our cohort. Unlike adults, children have few adverse reactions to the drug, suggesting that there may be a direct correlation between drug concentrations and incidence of ADRs. Our results suggest that studies with lower doses in adults may be warranted.
trial registrationClinicalTrials.gov NCT00699387.
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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.