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Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 09:53:20 GMT)

CTRI Number CTRI/2014/01/004294 [Registered on: 07/01/2014] - Terminated Trial Registered Last Modified On 31/12/2013 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Other (Specify) [Regimen] Study Design Randomized, Parallel Group Trial Public Title of Study management of patients who do not respond to initial anti- treatment Scientific Title of Management of patients who fail to Category II regimen of the TB control program Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Pauline Joseph Trial Coordinator (multi-center study) Designation Deputy Director (retired) Affiliation National Institute for Research In Tuberculosis Address National Institute for Research In Tuberculosis no.1 Sathiyamoorthy Road Chetpet Chennai 600031 Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Soumya Swaminathan Query) Designation Scientist G, Director Affiliation National Institute for Research in Tuberculosis Address National Institute for Research In Tuberculosis no.1 Sathiyamoorthy Road Chetpet Chennai Chennai TAMIL NADU 600031 India Phone 044-28369600 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Soumya Swaminathan Designation Scientist G, Director Affiliation National Institute for Research in Tuberculosis Address National Institute for Research In Tuberculosis no.1 Sathiyamoorthy Road Chetpet Chennai Chennai TAMIL NADU 600031 India

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Phone 044-28369600 Fax 044-28362528 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > United States agency for International Development, Ronald Reagan Building, Washington D.C. Primary Sponsor Primary Sponsor Details Name United State Agency for International Development Address Ronald Reagan Building,Washington,D.C. Type of Sponsor Other [United States federal government agency responsible for administering civilian foreign aid] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Soumya National Institute for Department of Clinical 044-28369600 Swaminathan Research in Research 044-28362528 Tuberculosis No.1,Sathiyamoorthy doctorsoumya@yahoo. Road Chetpet Chennai com Chennai TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Tuberculosis Research Approved 28/07/2007 No centre (ICMR),Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Multidrug Resistant Tuberculosis Intervention / Type Name Details Comparator Agent Intervention Injection kanamycin Intermittent Kanamycin is given (intramuscular) intermittent as intramuscular injection thrice weekly along with oral anti-TB drugs for 6 months Comparator Agent Injection Injection Kanamycin is given as Kanamycin(intramuscular)daily intramuscular injection daily along with oral anti-TB drugs for 6months Inclusion Criteria Inclusion Criteria Age From 15.00 Year(s) Age To 60.00 Year(s) Gender Both Details A patient whose TB is due to bacilli resistant to at least isoniazid and rifampicin with or without resistance to other drugs will be eligible for the study.
At least one sputum smear examined within 10 days of starting treatment should be positive for AFB. Exclusion Criteria Exclusion Criteria

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Details Patients under 15 years of age Pregnant women Having a current major psychiatric illness Having had over one month treatment with any second line anti-TB drugs. HIV positive cases A patient with concurrent illness such as epilepsy, renal or hepatic problems. Too sick for ambulatory treatment

Method of Generating Stratified randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints sputum smear and culture conversion at 3 sputum smear and culture conversion at 3 months and 6 months of treatment months and 6 months of treatment Secondary Outcome Outcome Timepoints Favourable bacteriological response at the end at 24 months of treatment of treatment. Adverse reactions to anti-TB drugs

Target Sample Size Total Sample Size=150 Sample Size from India=150 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 3 Date of First 30/08/2007 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=3 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Other (Terminated) Trial (India) Publication Details manuscript under publication Brief Summary The objective of the study was to compare the feasibility , effectiveness and acceptability of daily and thrice weekly injectables in the Standard Treatment Regimen of DOTS-Plus programme of RNTCP.

Patients who failed to the Category II regimen in RNTCP were referred for Culture and drug susceptibility testing .The MDR-TB patients identified were assessed for the study and suitable patients were randomized to daily and intermittent dosing of of injection kanamycin along with daily oral drugs. The treatment was given under supervision and patients were closely monitored. The duration of treatment was for 24 months with 12 months of post treatment follow up.

A total of 54 MDR-TB patients were enrolled in the study. Among them 26 patients received daily kanamycin (Regimen1) and 28 received thrice weekly kanamycin (Regimen 2).In Regimen 1 ,14 patients were cured, three failed and seven died . In R2 19 cured ,7 failed .The default proportion was similar in both the regimens. No death was reported in R2 and no recurrence of MDR-TB in either of the regimens. 46

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experienced adverse events with 19(35%) requiring modification of treatment.

Cure rate was similar in two regimens .Prompt diagnosis and initiation of treatment is warranted in patients who fail to retreatment regimens to prevent emergence of drug resistance. Further studies are required to ascertain the optimal dosing and duration of treatment regimens to ensure adherence to therapy and reduce the adverse events

The study was terminated and closed to recruitment of participants as the funding had stopped.A total of 54 MDR-TB patients were recruited to the trial before termination.

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