| 基本情報/Basic information |
| 一般向け試験名/Public title |
ジェニナック(R)錠200mg 特定使用成績調査
非定型肺炎に対する有効性と安全性の確認 |
Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia |
| 一般向け試験名略称/Acronym |
ジェニナック(R)錠200mg 特定使用成績調査
非定型肺炎に対する有効性と安全性の確認 |
Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia |
| 科学的試験名/Scientific Title |
ジェニナック(R)錠200mg 特定使用成績調査
非定型肺炎に対する有効性と安全性の確認 |
Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia |
| 科学的試験名略称/Scientific Title:Acronym |
ジェニナック(R)錠200mg 特定使用成績調査
非定型肺炎に対する有効性と安全性の確認 |
Specific post-marketing surveillance of Geninax(R) Tablets 200 mg
Efficacy and safety against atypical pneumonia |
| 試験実施地域/Region |
|
| 目的/Objectives |
| 目的1/Narrative objectives1 |
ジェニナック(R)錠の製造販売後における使用実態下での非定型肺炎に対する有効性と安全性を確認する。
ジェニナック(R)錠の適応菌種のうち，開発時に十分な症例数が集積できなかった肺炎マイコプラズマ (マイコプラズマ・ニューモニエ)，肺炎クラミジア (クラミジア・ニューモニエ) の感染情報を収集する。 |
To confirm the efficacy and safety of Geninax(R) Tablets against atypical pneumonia in daily clinical practice
To collect clinical data of patients with pneumonia caused by the following bacteria with which a sufficient number of patients infected could not be enrolled in the clinical studies of Geninax(R) Tablets (i.e., Mycoplasma pneumoniae and Chlamydophila pneumoniae) |
| 目的2/Basic objectives2 |
安全性・有効性/Safety,Efficacy |
| 目的2 -その他詳細/Basic objectives -Others |
|
|
| 試験の性質1/Trial characteristics_1 |
|
| 試験の性質2/Trial characteristics_2 |
|
| 試験のフェーズ/Developmental phase |
第Ⅳ相/Phase IV |
| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
|
| 介入1/Interventions/Control_1 |
ジェニナック(R)錠200mgを承認された用法・用量 (通常1回2錠を1日1回) で経口投与。投薬期間に制限はない。 |
Geninax(R) Tablets 200 mg was administered under the approved regimen (2 tablets of Geninax(R), once daily). The administration period was not limited. |
| 介入2/Interventions/Control_2 |
|
|
| 介入3/Interventions/Control_3 |
|
|
| 介入4/Interventions/Control_4 |
|
|
| 介入5/Interventions/Control_5 |
|
|
| 介入6/Interventions/Control_6 |
|
|
| 介入7/Interventions/Control_7 |
|
|
| 介入8/Interventions/Control_8 |
|
|
| 介入9/Interventions/Control_9 |
|
|
| 介入10/Interventions/Control_10 |
|
|
| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
|
| 年齢（上限）/Age-upper limit |
|
| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
15歳以上の患者
肺炎球菌の尿中抗原検査にて陰性の患者
成人市中肺炎診療ガイドラインの鑑別により非定型肺炎疑いと鑑別された患者
胸部X線の画像検査で急性に新たに出現したと考えられる浸潤影が認められる患者で，1側肺の2/3を超えない患者
咳嗽，胸痛，呼吸困難などの呼吸器症状を認める患者
経口摂取可能な患者
ジェニナック(R)錠の投薬開始時に他の抗菌薬，ステロイド剤の併用を必要としない患者
ジェニナック(R)錠の投薬開始前7日以内に他の抗菌薬が投薬されていない患者 |
Patients who were 15 years or older
Patients who had a negative result on Streptococcus pneumoniae urinary antigen test
Patients who were differentiated as having suspected atypical pneumonia according to the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults
Patients who had infiltrative shadows that deemed to have appeared acutely and newly on chest radiographic images and not exceeded 2/3 of one lung
Patients who had respiratory symptoms (e.g., cough, chest pain, or dyspnea)
Patients who could ingest orally
Patients who did not require a combination of other antibiotics or steroids when Geninax(R) Tablets therapy was initiated
Patients who took no other antibiotics within 7 days before initiation of Geninax(R) Tablets therapy |
| 除外基準/Key exclusion criteria |
ジェニナック(R)錠の成分又は他のキノロン系抗菌薬に対し過敏症の既往歴のある患者
妊娠又は妊娠している可能性のある患者，授乳中の患者
本調査に一度登録された患者
ジェニナック(R)錠の薬効判定が困難な患者
その他，担当医師が対象として不適当とした患者
|
Patients who had a history of hypersensitivity to Geninax(R) Tablets or other quinolones
Patients who were pregnant or possibly pregnant or were lactating
Patients who were previously enrolled in the study
Patients in whom drug efficacy of Geninax(R) Tablets was difficult to assess
Other patients whom the primary physician deemed to be ineligible as a target |
| 目標参加者数/Target sample size |
100 |
| 試験問い合わせ窓口/Public contact |
| 試験問い合わせ窓口担当者/Name of contact person |
|
| 名 |
|
| ミドルネーム |
|
| 姓 |
Satoru Kushimoto |
|
| 組織名/Organization |
富山化学工業株式会社 |
Toyama Chemical Co., Ltd. |
| 部署名/Division name |
安全性管理部 調査グループ |
Post-Marketing Surveillance Group, Pharmacovigilance & Surveillance Department |
| 郵便番号/Zip code |
|
| 住所/Address |
〒160-0023 東京都新宿区西新宿3-2-5 |
2-5, Nishishinjuku 3-chome, Shinjuku-ku, Tokyo 160-0023, Japan |
| 電話/TEL |
03-5381-3877 |
| 試験のホームページURL/Homepage URL |
|
| Email/Email |
satoru_kushimoto@toyama-chemical.co.jp |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
http://www.jiac-j.com/article/S1341-321X(14)00190-1/pdf |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
|
| 主な結果/Results |
安全性解析対象は105例，有効性解析対象は71例であった。
1．非定型肺炎に対する有効性は94.8% (55/58例) であった。Chlamydophila pnemoniae検出例 (他の菌との混合感染1例を含む) での有効率は4/4であり，Mycoplasma pneumoniae検出例 (他の菌との混合感染2例のうち1例の無効を含む) での有効率は90% (9/10例) であった。
2. 副作用発現率 (臨床検査値異常を含む) は，4.8% (5/105例) であり，発現した副作用は胃腸障害，感染症および寄生虫症，神経障害，皮膚および皮下組織障害で，それぞれ2.9% (3/105例)，1.0% (1/105例)，1.0% (1/105例)，1.0% (1/105例) であった。 |
The safety in 105 patients and the efficacy in 71 patients were examined.
1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients). The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain).
2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous
system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively. |
| 主な結果入力日/Results date posted |
|
| 結果掲載遅延/Results Delayed |
|
| 結果遅延理由/Results Delay Reason |
|
|
| 最初の試験結果の出版日/Date of the first journal publication of results |
|
| 参加者背景/Baseline Characteristics |
|
|
| 参加者の流れ/Participant flow |
|
|
| 有害事象/Adverse events |
|
|
| 評価項目/Outcome measures |
|
|
| 個別症例データ共有計画/Plan to share IPD |
|
|
| 個別症例データ共有計画の詳細/IPD sharing Plan description |
|
|
UMIN-CTR ホーム