Evidence map›Paper›PMID 37554997›Full record

ArticleThe Lancet regional health. Western Pacific2023

Safety, efficacy and pharmacokinetics of palivizumab in off-label neonates, infants, and young children at risk for serious respiratory syncytial virus infection: a multicenter phase II clinical trial.

Masaaki Mori, Kanako Yoshizaki, Shinichi Watabe, Mika Ishige, Akinari Hinoki, Takuya Kondo, Tomoaki Taguchi, Hisaya Hasegawa, Tomoko Hatata, Naoyuki Tanuma and 7 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet regional health. Western Pacific, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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

11 citing papers in PubMed.

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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

17 authors.

Masaaki MoriDepartment of Pediatrics, Tokyo Medical and Dental University Medical Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
Kanako YoshizakiDepartment of Pediatrics, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan.
Shinichi WatabeDepartment of Pediatrics, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan.
Mika IshigeDepartment of Pediatrics and Child Health, Nihon University School of Medicine, 1-6 Kanda Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan.
Akinari HinokiDepartment of Rare/Intractable Cancer Analysis Research, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan.
Takuya KondoDepartment of Pediatric Surgery, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
Tomoaki TaguchiDepartment of Pediatric Surgery, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
Hisaya HasegawaDivision of Neonatal Intensive Care, Tokyo Women's Medical University, Adachi Medical Center, 4-33-1 Kohoku, Adachi-ku, Tokyo 123-8558, Japan.
Tomoko HatataDepartment of Pediatric Surgery, Nagano Children's Hospital, 3100 Toyoshina, Azumino, Nagano 399-8288, Japan.
Naoyuki TanumaDepartment of Pediatrics, Tokyo Metropolitan Fuchu Medical Center for the Disabled, 2-9-2 Musashidai, Fuchu, Tokyo 183-8553, Japan.
Kosuke KirinoDepartment of Data Science, Clinical Research Center, National Center for Child Health and Development, 2-10-1 Ohkura, Setagaya-ku, Tokyo 157-0074, Japan.
Akihiro HirakawaDepartment of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan.
Takuya NarutoClinical Research Institute, Kanagawa Children's Medical Center, 2-138-4 Mutsukawa, Minami-ku, Yokohama 232-8555, Japan.
Minoru ImaiMedical Innovation Promotion Center, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan.
Ryuji KoikeMedical Innovation Promotion Center, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan.
Kenichiro HosoiDepartment of Pediatrics, Faculty of Medicine, Kyorin University, 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan.
Satoshi KusudaDepartment of Pediatrics, Faculty of Medicine, Kyorin University, 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Pediatric patients with certain rare diseases are at increased risk of severe respiratory syncytial virus (RSV) infection. However, the prophylactic use of anti-RSV antibody (palivizumab) in these patients is not indicated at present in Japan. Methods: This first-in-the-world multicenter, uncontrolled, open-label, phase II clinical trial was carried out between 28 July 2019 and 24 September 2021 at seven medical institutions in Japan to investigate the efficacy, safety, and pharmacokinetics of palivizumab in 23 subjects recruited from among neonates, infants, or children aged 24 months or younger who had any of the following conditions: pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, inherited metabolic disease, or neuromuscular disease. At least four continuous doses of palivizumab were administered intramuscularly at 15 mg/kg at intervals of 30 days. Findings: Twenty-three enrolled subjects completed the study. No subject required hospitalization for RSV. Adverse events (AE) did not notably differ from the event terms described in the latest interview form. Five severe AEs required unplanned hospitalization, but resolved without RSV infection. Therapeutically effective concentrations of palivizumab were maintained throughout the study period. Interpretation: Palivizumab might be well tolerated and effective in preventing serious respiratory symptoms and hospitalization due to severe RSV infection, indicating the prophylactic use in the pediatric patients included in this study. Funding: Japan Agency for Medical Research and Development (AMED), grant numbers 19lk0201097h0001 (to MM), 20lk0201097h0002 (to MM), 21lk0201097h0003 (to MM), and 22lk0201097h0004 (to MM). AMED did not have any role in the execution of this study, analysis and interpretation of the data, or the decision to submit the results.

Indexed as

Airway stenosisCongenital esophageal atresiaEfficacyInherited metabolic diseaseNeuromuscular diseasePalivizumabPediatric patientPulmonary hypoplasiaRespiratory syncytial virus infection

Identifiers

PMID37554997
PMCPMC10405310

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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.