Mycobacteria infection in incomplete transverse myelitis

ISRCTN	ISRCTN57081310
DOI	https://doi.org/10.1186/ISRCTN57081310
Secondary identifying numbers	N/A

Submission date: 27/03/2010
Registration date: 09/04/2010
Last edited: 09/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Yanqing Feng
Scientific

Department of Neurology
Sun Yat-sen University
Zhongshan 2 Road 58
Guangzhou
510080
China

Study information

Study design	Prospective open-label pilot study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Antituberculosis treatment in incomplete transverse myelitis in steroid-refractory patients: a prospective open label study
Study acronym	ATT in myelitis
Study objectives	Incomplete transverse myelitis (ITM) of unknown origin is associated with high rates of morbidity and mortality, and treatment options for these patients are few. This pilot study was undertaken to determine whether antituberculous treatment (ATT) might help in patients with ITM whose condition continued to worsen despite receiving steroid treatment.
Ethics approval(s)	Ethics Committee of the First Affiliated Hospital of Sun Yat-Sen University approved in June 2003
Health condition(s) or problem(s) studied	Incomplete transverse myelitis (ITM)
Intervention	Prior to ATT initiation, all treatments with corticosteroids and other systemic immunosuppression therapy were discontinued. Our treatment protocols consisted of three antituberculous drugs regimen (isoniazid, rifampicin and pyrazinamide were used for 9 months), followed by a combination of isoniazid and rifampicin until 24 months. The dose of isoniazid was 8 mg/kg/day, rifampicin was 10 mg/kg/day, and pyrazinamide 25 mg/kg/day. Treatment was under our extensive observation. All patients had the following weekly liver function tests for the first one month of therapy and subsequently every 3 monthly: serum bilirubin, serum transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) and alkaline phosphatase. All patients were followed up for at least 1 year after treatment.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Isoniazid, rifampicin, pyrazinamide
Primary outcome measure	Before the start of the assigned treatment all patients had a baseline visit, at which the medical history was obtained, and physical and neurological examinations were undertaken. The American Spinal Injury Association (ASIA) standards were adopted to assess subjects' neurological status. We used the ASIA Impairment Scale to evaluate sensory and motor function and neurological level. Activities of daily living (ADL) were assessed by Barthel Index (BI) (0 - 100 scale, with lower scores denoting less independence in activities of daily living); mobility were scored by the Hauser Ambulation Index.
Secondary outcome measures	1. Changes in quality of life, measured by the ASIA, BI and AI at baseline and at 12 months 2. MRI changes assessed at baseline and at 12 months Each patient was followed up and assessed by the same physician during the study.
Overall study start date	01/01/2003
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	67 participants
Key inclusion criteria	1. Development of sensory, motor, or autonomic dysfunction attributable to the spinal cord 2. Varying degrees of motor, sensory and sphincter dysfunction (though not necessarily symmetrical), but without complete paraplegia 3. Exclusion of extra-axial compressive aetiology by magnetic resonance imaging (MRI) 4. Worsened condition despite at least one 5-day course of intravenous (IV) methylprednisolone (0.5 - 1 g/d) 5. Cerebrospinal fluid mycobacterium tuberculosis (CSF MTB) culture were negative, with cell count less than 50/mm^3 and total protein less than 1.5 g/L 6. Aged 18 - 70 years, either sex
Key exclusion criteria	1. Sudden onset 2. History of previous radiation to the spine within the last 10 years 3. Central nervous system (CNS) manifestations of syphilis, Lyme disease, human immunodeficiency virus (HIV) infection 4. Clear arterial distribution clinical deficit consistent with thrombosis of the anterior spinal artery 5. History of clinically apparent optic neuritis 6. Brain MRI abnormalities suggestive of multiple sclerosis (MS) and clinically definite MS 7. Serologic or clinical evidence of connective tissue disease (sarcoidosis, Behcet's disease, Sjögren's syndrome, systematic lupus erythematosis [SLE], mixed connective tissue disorder, etc)
Date of first enrolment	01/01/2003
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

China

Study participating centre

Department of Neurology

Guangzhou
510080
China

Sponsor information

Sun Yat-sen University (China)
University/education

c/o Yanqing Feng
Department of Neurology
Zhongshan 2 Road 58
Guangzhou
510080
China

Email	fyqgz@sina.com
Website	http://www.sysu.edu.cn/
"ROR"	https://ror.org/0064kty71

Funders

Funder type

Other

Investigator initiated and funded (China)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan