Trial reportJournal of the Pediatric Infectious Diseases Society2016
A Randomized, Double-Blind, Placebo-Controlled Trial of Pleconaril for the Treatment of Neonates With Enterovirus Sepsis.
Trial report in Journal of the Pediatric Infectious Diseases Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05962645 (A Phase 1 Study to Confirm the Single- and Multiple-dose Pharmacokinetics and to Evaluate Food Effect of Vapendavir in Healthy Participants and Participants With COPD), which is not on this map. Cited by 54 papers, 1 of them a synthesis 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 Phase 1 Study to Confirm the Single- and Multiple-dose Pharmacokinetics and to Evaluate Food Effect of Vapendavir in Healthy Participants and Participants With COPD
Who cites it
54 citing papers in PubMed, 1 synthesis or guideline pooled it, 162 citations in OpenAlex.
- Clinical characteristics of severe neonatal enterovirus infection: a systematic review.BMC pediatrics · 2021Pooled it
- Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial.Nature medicine · 2023Trial
- Neonatal enterovirus myocarditis outcomes following extracorporeal membrane oxygenation (NEMO-ECMO): An ELSO registry analysis.JHLT open · 2026Article
- Persistent pulmonary hypertension, neonatal stroke, coagulopathy and multi-organ failure due to severe enterovirus sepsis: two case reports.BMC pediatrics · 2026Article
- A review of post-exposure strategies for high-consequence viral pathogens in the laboratory.Clinical microbiology reviews · 2025Review
- Current infectious disease management challenges in inborn errors of immunity.Annals of clinical microbiology and antimicrobials · 2025Review
- Fatal Neonatal Echovirus 11 Infection Following Maternal Peripartum Illness: A Case Report with Literature Review.AJP reports · 2025Article
- Advances in the Treatment of Enterovirus-D68 and Rhinovirus Respiratory Infections.Infectious disease reports · 2025Review
- Review
- Two dramatically different clinical scenarios of neonatal Echovirus-11 infection in late preterm male twins: a case report and review of the literature.Italian journal of pediatrics · 2025Review
- Synergistic combination of orally available safe-in-man pleconaril, AG7404, and mindeudesivir inhibits enterovirus infections in human cell and organoid cultures.Cellular and molecular life sciences : CMLS · 2025Article
- Viral sepsis: diagnosis, clinical features, pathogenesis, and clinical considerations.Military Medical Research · 2024Review
- Antiviral Development for the Polio Endgame: Current Progress and Future Directions.Pathogens (Basel, Switzerland) · 2024Review
- The Role and Implications of COVID-19 in Incident and Prevalent Heart Failure.Current heart failure reports · 2024Review
- Viral Polymerase Chain Reaction Testing of the Cerebrospinal Fluid: Comprehensive Care for Neonates With a Fever.Cureus · 2024Article
- From the "One-Molecule, One-Target, One-Disease" Concept towards Looking for Multi-Target Therapeutics for Treating Non-Polio Enterovirus (NPEV) Infections.Pharmaceuticals (Basel, Switzerland) · 2024Review
- The Scope and Impact of Viral Infections in Common Variable Immunodeficiency (CVID) and CVID-like Disorders: A Literature Review.Journal of clinical medicine · 2024Review
- Review
- The inflammatory spectrum of cardiomyopathies.Frontiers in cardiovascular medicine · 2024Review
- Severe and fatal neonatal infections linked to a new variant of echovirus 11, France, July 2022 to April 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023Article
Corrections and comments
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Authors and funding
21 authors at 15 institutions in 2 countries.
Funding
Abstract
backgroundNeonatal enterovirus sepsis has high mortality. Antiviral therapy is not available.
methodsNeonates with suspected enterovirus sepsis (hepatitis, coagulopathy, and/or myocarditis) with onset at ≤15 days of life were randomized 2:1 to receive oral pleconaril or placebo for 7 days. Serial virologic (oropharynx, rectum, urine, serum), clinical, pharmacokinetic, and safety evaluations were performed.
resultsSixty-one subjects were enrolled (43 treatment, 18 placebo), of whom 43 were confirmed enterovirus infected (31 treatment, 12 placebo). There was no difference in day 5 oropharyngeal culture positivity (primary endpoint; 0% in both groups). However, enterovirus-infected subjects in the treatment group became culture negative from all anatomic sites combined faster than placebo group subjects (median 4.0 versus 7.0 days, P = .08), and fewer subjects in the treatment group remained polymerase chain reaction (PCR)-positive from the oropharynx when last sampled (23% versus 58%, P = .02; median, 14.0 days). By intent to treat, 10/43 (23%) subjects in the treatment group and 8/18 (44%) in the placebo group died (P = .02 for 2-month survival difference); among enterovirus-confirmed subjects, 7/31 (23%) in the treatment group died versus 5/12 (42%) in the placebo group (P = .26). All pleconaril recipients attained concentrations greater than the IC90 after the first study day, but 38% were less than the IC90 during the first day of treatment. One subject in the treatment group and three in the placebo group had treatment-related adverse events.
conclusionsShorter times to culture and PCR negativity and greater survival among pleconaril recipients support potential efficacy and warrant further evaluation.
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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.