UMIN-CTR Clinical Trial

Basic information
Public title	Antibiotics for multidrug-resistant tuberculosis: network meta-analysis.
Acronym	Abx. for MDR-TB. NMA
Scientific Title	Antibiotics for multidrug-resistant tuberculosis: network meta-analysis.
Scientific Title:Acronym	Abx. for MDR-TB. NMA
Region	Japan

Condition
Condition	MDR-TB
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Tuberculosis infection is a communicable disease caused by Mycobacterium tuberculosis, which usually spread from person to person through the air. Globally, an estimated 1.5 million people died out of 10 million tuberculosis (TB) cases. World Health Organization estimated global incidence of multidrug-resistant tuberculosis (MDR-TB) at 0.4 million cases/year. Due to the resistance to the two key drugs, isoniazid and rifampicin, the treatment of MDR-TB demands the use of the later-line medications, which are usually less effective and less safe compared to the first-line medications. Besides, some of new antibiotics that are reportedly effective for MDR-TB such as Delamanid and Bedaquiline are excessively expensive, which hampers daily administration in MDR-TB-prevalent developing countries. These factors made treatment of MDR-TB extraordinary difficult. World Health Organization documented that treatment success rate for people with MDR-TB and rifampicin-resistant TB was as low as 56%. The 2019 consolidated WHO guidelines hierarchically grouped medications for MDR-TB into three groups. All three of Group A agents and at least one Group B agent should be included to ensure that treatment starts with at least four TB agents likely to be effective. This strategy is supported by observational study, RCT, and systematic review. However, most of previous RCT and systematic review of MDR-TB treatment adopted a pair-wise approach, which permits comparison of only two regimens. When choosing a drug for a regimen, clinicians need to know the relative effectiveness and safety of many available options. We planned this systematic review and network meta-analysis to comprehensively assess the efficacy and safety of MDR-TB drugs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	WHO 2008 defined outcomes. World Health Organization.Guidelines for the programmatic management of drug-resistant tuberculosis: emergency update 2008. 2008. Available at: Guidelines for the programmatic management of drug-resistant tuberculosis: emergency update 2008. Accessed on Mar 1st, 2020.
Key secondary outcomes	Adverse effect. Time to culture conversion.

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	MDR-TB
Key exclusion criteria	NA
Target sample size

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University
Division name	Department of Pulmonology
Zip code	236-0032
Address	3-9, Fukuura, Kanazawa, Yokohama
TEL	045-787-2800
Email	nobuyuki_horita@yahoo.co.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University
Division name	Department of Pulmonology
Zip code	236-0032
Address	3-9, Fukuura, Kanazawa, Yokohama
TEL	045-787-2800
Homepage URL
Email	nobuyuki_horita@yahoo.co.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB not required
Address	IRB not required
Tel	000-000-0000
Email	dummy@ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2020 Year 03 Month 05 Day
Date of IRB	2020 Year 03 Month 05 Day
Anticipated trial start date	2020 Year 03 Month 05 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study search A search formula for PubMed is the following: ((multidrug [title] resistant[title]) OR MDR[title]) (tuberculosis[title] OR TB[title]) and (randomized OR randomised OR randomly OR phase). Similar search formulas were used for other databases. The search will be done on March 10th, 2020. Publication type Any of English article, non-English article, full-length article, short article, and conference abstract may be included. Trials We will include parallel-group individual RCTs but not quasi RCTs, cluster RCTs, or cross-over RCTs. A trial with three or more arms will be accepted. Along with superiority trials, non-inferiority trials will be allowed. Any phase RCT may be included. A trial evaluating at least one of our outcomes will be included. Patients We will include MDR-TB patients regardless of age, smear status, and HIV status. A case with Rifampicin-resistant Isoniazid-susceptible TB is not our concern.

Management information
Registered date	2020 Year 03 Month 05 Day
Last modified on	2021 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045282