Clinical trial comparing High dose rifampicin and Conventional dose of rifampicin in drug sensitive pulmonary tuberculosis patients

Phase 2

Active, not recruiting

Conditions: Tuberculosis of lung,

Registration Number: CTRI/2017/12/010951

Lead Sponsor: India TB Research Consortium

Brief Summary: Despite wide implementation of highly efficacious regimen TB still remains a global health emergency as current 6 month period of treatment poses formidable challenges to the programme. Rifampicin is a unique drug explored widely for shortening TB treatment and it also cheaper and is being manufactured by generic companies. Using High dose Rifampicin is one such approach.Additionally there is in-vitro, animal and human evidence from different ethnic populations that higher than standard dose of Rifampicin can be safely and successfully used to shorten he treatment duration and reduces relapses and causes early culture conversion.Also pharmacokinetic studies from our institute have shown that current dosages are sub therapeutic and imapacts the treatment outcomes. But there is sparse data on safety and pharmacokinetics from Indian population so we propose to undertake this trial to investigate the effect of high dose Rifampicin on the safety tolerability and PK comparing with the conventional dose of Rifampicin in treating pulmonary TB patients

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 327

Inclusion Criteria

Residing in or around the study sites No prior history of ATT (or < 15 days of ATT) At least 2 sputum smears should be positive for TB bacilli At least 1 sputum should be RMP /INH sensitive by GeneXpert /LPA Express willingness to attend the treatment centre for supervised treatment Express willingness to give written informed consent.

Exclusion Criteria

Body weight < 30 kgs or > 65 kgs Hepatic or renal disease history of liver disease, current ALT > 2.5 times ULN total bilirubin >1.2 times ULN Serum Creatinine >1.2 mg/dL Blood Urea >43 mg/dL Haemoglobin <7.0 g/dL or platelet count <150,000/mm3, or WBC <4500 cells/Î¼L Psychiatric illness History of seizure or loss of consciousness Seriously ill (Karnofsky scale <50) Sero-positive for HIV virus antibodies Serology positive for HBS Ag or Hepatitis C virus antibody Pregnancy or lactation Diabetics on Insulin.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants with treatment emergent adverse events with high dose RMP, 25 or 35 mg/kg/daily, (intervention arm) versus the standard 10 mg/kg dose of rifampicin (control arm) when given daily along with other first-line anti-TB drugs during the 8 -weeks anti-TB treatment of new sputum smear and culture positive PTB	2 months (8weeks)

Secondary Outcome Measures

Name	Time	Method
Drug concentrations and PK parameters of RMP between trial regimens	Proportion of patients with negative sputum cultures every week till 2nd month and at 3rd ,4th month and at end of treatment

Trial Locations

Locations (4): King Georges Medical University
🇮🇳
Lucknow, UTTAR PRADESH, India
National Institute for Research in Tuberculosis
🇮🇳
Chennai, TAMIL NADU, India
National Institute of TB and Respiratory Diseases
🇮🇳
Delhi, DELHI, India
Post Graduate Institute of Medical Education and Research
🇮🇳
Chandigarh, CHANDIGARH, India
King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Surya Kanth
Principal investigator
skantpulmed@gmail.com