Compare the effectiveness of two types of drugs to treat tuberculosis

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014051917764N1
• Date of registration: 2014-09-13
• Prospective Registration: No
• Primary sponsor: vice chancellor for research, Urmia University of Medical Sciences
• Public title: Compare the effectiveness of two types of drugs to treat tuberculosis
• Scientific title: Survey of treatment outcome smear-positive pulmonary tuberculosis patients Treated with fixed-dose drug combination regime in compared whith those separate regime: a randomized clinical trial
• Date of first enrolment: 2014-06-22
• Target sample size: 300
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/16275
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
• Phase: 2-3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Salari Lak Shaker
• Affiliation: Urmia University of Medical Sciences

• Name: Fallah Saeid
• Affiliation: Urmia University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria: New cases of sputum smear positive; Patient weight more than 30kg; Adult (greater than13 years); No disease - diabetes, immune deficiency, liver or kidney disease; Informed consent.
Exclusion Criteria: Smear-negative tuberculosis patients; Patients with a history of anti-TB medication use; Children younger than 13 years; Patients weighing less than 30 kg; Tuberculosis patients with diabetes, immune deficiency, liver or kidney disease; Lack of consent to participate in the study.
Exclusion criteria:

Age minimum: 13 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis.
Tuberculosis of lung, confirmed by sputum microscopy with or without culture

Tuberculosis of lung, confirmed by sputum microscopy with or without culture

Intervention(s)

3.The control group will be treated with the separate Anti-TB drug regimen that contains Rifampicin 8-12 mg per kg body weight, Isoniazid 4-6 mg per kg body weight, Pyrazinamide 20-30 mg per kg body weight and Ethambutol 15-20 mg per kg body weight. the total treatment period will be lasted 6 months. Within two months of starting treatment, patients will consume four separate drugs daily meals and fasting containing Rifampicin, Isoniazid, Pyrazinamide and Ethambutol, but in the next four month, patients will consume two separate drugs daily meals and fasting containing Rifampin and Isoniazid.

2. The intervention group will be treated with a combination of Anti-TB drug and whit a fixed dose that contains Rifampicin 8-12 mg per kg body weight, Isoniazid 4-6 mg per kg body weight, Pyrazinamide 20-30 mg per kg body weight and Ethambutol 15-20 mg per kg body weight. the total treatment period will be lasted 6 months. Within two months of starting treatment, patients will consume a combination of four drugs daily meals and fasting containing Rifampicin, Isoniazid, Pyrazinamide and Ethambutol, but in the next four month, patients will consume a combination of two drugs daily meals and fasting containing Rifampin and Isoniazid.

Treatment - Drugs

Intervention 1: 2. The intervention group will be treated with a combination of Anti-TB drug and whit a fixed dose that contains Rifampicin 8-12 mg per kg body weight, Isoniazid 4-6 mg per kg body weight, Pyrazinamide 20-30 mg per kg body weight and Ethambutol 15-20 mg per kg body weight. the total treatment period will be lasted 6 months. Within two months of starting treatment, patients will consume a combination of four drugs daily meals and fasting containing Rifampicin, Isoniazid, Pyrazinamide and Ethambutol, but in the next four month, patients will consume a combination of two drugs daily meals and fasting containing Rifampin and Isoniazid. Intervention 2: 3.The control group will be treated with the separate Anti-TB drug regimen that contains Rifampicin 8-12 mg per kg body weight, Isoniazid 4-6 mg per kg body weight, Pyrazinamide 20-30 mg per kg body weight and Ethambutol 15-20 mg per kg body weight. the total treatment period will be lasted 6 months. Within two months of starting treatment, patients will consume four separate drugs daily meals and fasting containing Rifampicin, Isoniazid, Pyrazinamide and Ethambutol, but in the next four month, patients will consume two separate drugs daily meals and fasting containing Rifampin and Isoniazid.

Primary Outcome(s)

Sputum conversion rate. Timepoint: 2 , 3 and 6 month after Starting Treatment. Method of measurement: sputum smear status is investigated by optical microscope at the end of the second, third and sixth months of treatment and the result are registered in the checklist.

Source(s) of Monetary Support

vice chancellor for research, Urmia University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Urmia University of Medical Sciences