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

Phase IIb open label, parallel, randomized controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics and anti-bacterial activity of High dose rifampicin versus Conventional dose of Rifampicin along with standard anti-tubercular therapy (ATT) in drug sensitive adult patients of pulmonary tuberculosis - HICON -R

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010951

Enrollment

327

Registered

2017-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Adult Sputum smear positive Pulmonary TB patients Health Condition 2: A150- Tuberculosis of lung

Interventions

Intervention1: Rifampicin 25 mg/kg body weight OD for 2 months,Rifampicin 35 mg/kg body weight OD for 2 months: (1) High dose Rifampicin (25mg/kg/day), Isoniazid, Pyrazinamide and Ethambutol, daily fo

Eligibility

Inclusion criteria

Inclusion criteria: Residing in or around the study sites No prior history of ATT (or 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

Exclusion criteria: Body weight 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 Psychiatric illness History of seizure or loss of consciousness Seriously ill (Karnofsky scale Sero-positive for HIV virus antibodies Serology positive for HBS Ag or Hepatitis C virus antibody Pregnancy or lactation Diabetics on Insulin

Design outcomes

Primary

Measure	Time frame
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 Timepoint: 2 months (8weeks)	—

Secondary

Measure	Time frame
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 Time to sputum culture conversion To evaluate rate of change in time to sputum culture positivity across the treatment arms over 8 and 16 weeks of treatment period Identification of predictive biomarkers of drug induced liver injury Timepoint: 2 months and at 18 months	—

Measure

Time frame

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 Time to sputum culture conversion To evaluate rate of change in time to sputum culture positivity across the treatment arms over 8 and 16 weeks of treatment period Identification of predictive biomarkers of drug induced liver injury Timepoint: 2 months and at 18 months

—

Countries

India

Contacts

Public ContactDr Bhavani P K

National Institute for research in Tuberculosis

bhavani.pk@nirt.res.in9962934169

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026