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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000021979
受付番号 R000025319
科学的試験名
一般公開日(本登録希望日) 2016/05/02
最終更新日 2016/04/19

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Identification of nontuberculous mycobacteria in cervical lymphadenitis among HIV positive and HIV negative adults
一般向け試験名略称/Acronym
Identification of nontuberculous mycobacteria in cervical lymphadenitis among HIV positive and HIV negative adults
科学的試験名/Scientific Title
Identification of nontuberculous mycobacteria in cervical lymphadenitis among HIV positive and HIV negative adults
科学的試験名略称/Scientific Title:Acronym
Identification of nontuberculous mycobacteria in cervical lymphadenitis among HIV positive and HIV negative adults
試験実施地域/Region
北米/North America

対象疾患/Condition
対象疾患名/Condition
Original study
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information はい/YES

目的/Objectives
目的1/Narrative objectives1
Identification of nontuberculosis mycobacteria in cervical lymphadenopathies among HIV positive and HIV negative
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
Identify and establish the frequency of infectious etiology by nontuberculous mycobacteria in Mexican adult patients with cervical lymphadenopathy.
試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Establish the frecuency of infectious etiology by nontuberculous micobacteria among adults HIV positive
副次アウトカム評価項目/Key secondary outcomes
Establish the frecuency of infectious etiology by nontuberculous micobacteria among adults HIV negative

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 単群/Single arm
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無対照/Uncontrolled
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 知る必要がない/No need to know

介入/Intervention
群数/No. of arms 1
介入の目的/Purpose of intervention 診断/Diagnosis
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1
Biopsy of the lymph node for the histopathological study was carried out as well as a search for acid-fast bacilli and tube culture to indicate growth of Mycobacterim BACTEC (MGIT-960) and identification of mycobacterial strain by PCR-RFLP (Restriction fragment length polymorfism) of hsp65.
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
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
90 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Patients who experienced growth of cervical lymph node chains, a temperature higher, weight loss and general malaise
除外基準/Key exclusion criteria
Without prior TB treatment
目標参加者数/Target sample size 150

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Alejandro Hernandez Solis
所属組織/Organization
Hospital General de Mexico y Facultad de Medicina, UNAM, Mexico.
所属部署/Division name
Unidad de Neumologia y Cirugia de Torax.
郵便番号/Zip code
住所/Address
Dr. Balmis 148, Cuauhtemoc, Doctores, 06726 Ciudad de Mexico, Mexico
電話/TEL 5527892000
Email/Email eliza1726_9@hotmail.com

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

ミドルネーム


ミドルネーム
Elizabeth Luis Martinez
組織名/Organization
Hospital General de Mexico y Facultad de Medicina, UNAM, Mexico.
部署名/Division name
Unidad de Neumologia y Cirugia de Torax.
郵便番号/Zip code
住所/Address
Dr. Balmis 148, Cuauhtemoc, Doctores, 06726 Ciudad de Mexico, Mexico
電話/TEL 5513213659
試験のホームページURL/Homepage URL http://www.hgm.salud.gob.mx/
Email/Email eliza1726_9@hotmail.com

実施責任組織/Sponsor
機関名/Institute その他 Hospital General de Mexico
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 None
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization
None

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
None
その他の研究費提供組織/Name of secondary funder(s)
None

IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2016 05 02

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results
Out of 150 cases admitted on suspicion of lymphatic tuberculosis, 40 (26%) cases of positive culture for mycobacteria were confirmed, 20 patients were diagnosed HIV positive by Western blot, the average CD4 count was <100 cels/mm3, the most common symptoms were fever (75%) and general malaise (90%), six patients had pulmonary tuberculosis on entry and there was one case of tuberculous meningitis. In the group of 20 HIV-negative patients, the predominant symptoms were fever (90%) and general malaise (40%), three patients had pulmonary tuberculosis. 
In biopsies of the lymph node for HIV positive patients, Zhiel-Neelsen staining was positive in seven cases (35%), growth of Mycobacterim in BACTEC (MGIT-960) was positive in all cases with an average growth of 38 days. In biopsies of lymph node for HIV negative patients, Ziehl-Neelsen staining was positive in 10 cases (50%), the culture was positive in all biopsies with an average growth of 32 days. 
Of the 40 strains isolated from the material of the lymph node biopsy, in the group of HIV-positive, 17 (85%) were identified as M. tuberculosis complex on obtaining an amplification of approximately 140 bp (Figure 1), corresponding to the insertion sequence IS6110; three (15%) strains did not show an amplification product for IS6110, so the identification of species was performed by PCR-RFLP. The restriction patterns obtained for amplifying 441 bp hsp65 strains being studied (figure 2), detected 2 strains of M. intracellulare (10%) and one (5%) of M. gordonae. Of the HIV negative group 19 (95%) of strains corresponded to the M. tuberculosis complex and one strain (5%) was identified as M. fortuitum. For the 20 HIV-negative cases and 20 HIV positive cases, a significant difference t-Student (p-value minor 0.001) was found for independent samples in Pearson X2, 95% CI.

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


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2010 01 20
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2013 10 10
フォロー終了(予定)日/Last follow-up date
2014 10 09
入力終了(予定)日/Date of closure to data entry
2014 11 05
データ固定(予定)日/Date trial data considered complete
2015 05 22
解析終了(予定)日/Date analysis concluded
2015 12 20

その他/Other
その他関連情報/Other related information
PPD skin testing (a halo of induration> 10 mm) was positive in five (25%) of HIV-positive patients and in 12 (60%) of HIV negative patients.
In the group of HIV-positive patients, 16 (80%) died within one year, including six with pulmonary tuberculosis and one with meningitis and four (20%) recovered a year after starting specific treatment (DOTS). In the group of HIV-negative patients 17 (85%) of patients were cured of lymphopathy, three had pulmonary TB and one (5%) discontinued treatment

管理情報/Management information
登録日時/Registered date
2016 04 19
最終更新日/Last modified on
2016 04 19


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000025319
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025319

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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