Evidence map›Paper›PMID 35806868›Full record

ArticleJournal of clinical medicine2022

Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan.

Ichiro Morioka, Yasumasa Kakei, Takashi Omori, Kandai Nozu, Kazumichi Fujioka, Naoto Takahashi, Tetsushi Yoshikawa, Hiroyuki Moriuchi, Yoshinori Ito, Akira Oka and 1 more

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 4% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Long-Term Outcomes in Children With Congenital Cytomegalovirus Infection.Laryngoscope investigative otolaryngology · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Treatment of congenital cytomegalovirus infection.Clinical and experimental pediatrics · 2023
    Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

Ichiro MoriokaDepartment of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo 173-8610, Japan.ORCID 0000-0002-5685-2670
Yasumasa KakeiDepartment of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.ORCID 0000-0002-5997-514X
Takashi OmoriDivision of Biostatistics, Department of Social/Community Medicine and Health Science, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.
Kandai NozuDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.ORCID 0000-0002-0290-3137
Kazumichi FujiokaDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.ORCID 0000-0002-9913-6447
Naoto TakahashiDepartment of Pediatrics, The University of Tokyo, Tokyo 113-8655, Japan.ORCID 0000-0002-2353-4430
Tetsushi YoshikawaDepartment of Pediatrics, Fujita Health University School of Medicine, Toyoake 470-1192, Japan.
Hiroyuki MoriuchiDepartment of Pediatrics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, Japan.
Yoshinori ItoDepartment of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo 173-8610, Japan.
Akira OkaDepartment of Pediatrics, The University of Tokyo, Tokyo 113-8655, Japan.
Japanese Congenital Cytomegalovirus Study Group
Kobe University · JPNihon University · JPFujita Health University · JPKobe University Hospital · JPNagasaki University · JPSaitama Children's Medical Center · JPThe University of Tokyo · JP

Funding

Japan Agency for Medical Research and Development JP18gk0110021h0003 and JP19gk0110037
6 · The paper itself

Abstract

Our aims were to determine the clinical impact of oral valganciclovir (VGCV) in infants aged ≤2 months with congenital cytomegalovirus (CMV) disease and evaluate the efficacy of VGCV when initiated beyond the neonatal period. The multicenter, single-arm, open-label clinical trial was conducted in Japan. Twenty-five infants aged ≤2 months with congenital CMV disease involving the central nervous system were enrolled and treated with VGCV for 6 months. The primary endpoint was the change in the whole blood CMV load before and after treatment. The secondary endpoint was the change in the auditory brainstem response (ABR) before and after treatment. Changes in ABR were assessed between the younger and older age groups (≤ and >30 days at treatment initiation). Of the 25 patients, one was excluded owing to epilepsy before VGCV administration. The median change in the CMV DNA level in whole blood was −246.0 IU/mL. The best ear and total ear assessments based on ABR were categorized as (improved + unchanged) after treatment for 100% and 93.8%, respectively. No differences in hearing efficacy were observed between the younger and older age groups. Oral VGCV is a potential therapeutic option for treating infants aged ≤2 months with congenital CMV disease.

Indexed as

auditory brainstem responseclinical trialcytomegalovirusneonateneutropeniavalganciclovir

Identifiers

PMID35806868
PMCPMC9267258
OpenAlexW4283266346

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.