To asses the Efficacy, Safety and Tolerability of 4-month regimen containing Ofloxacin compared to theStandard 6-month regimen in the treatment of patients withSuperficial tuberculosis lymphnode

Phase 3

Conditions: Health Condition 1: null- TB Lymphadenitis

Registration Number: CTRI/2013/03/003481

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Age 18 years and above

2.Residing in or around Madurai and Chennai.

3.No anti-TB treatment in the past or should have had less than one month of treatment (but less than one week in the preceding one month prior to enrollment to the study).

4.Confirmation of the diagnosis of tuberculosis of the superficial lymph node either by histopathology or bacteriology (culture) of the open lymph node biopsy specimen.

5.Express willingness to attend the treatment centre for supervised treatment.

6.Express willingness for home visits by the staff of the center. However in special circumstances if the doctor and social worker considers the patient to be very co-operative and if the patient objects to home visits, this may be waived.

7.Express willingness to give informed written consent.

Exclusion Criteria

1.Body weight less than 30 kg.

2.Patients with smear positive and smear negative pulmonary TB.

3.Severe forms of extra-pulmonary TB (meningitis, pleural, renal, gastrointestinal, pericardial, bone and joint).

4.Patients with x-ray suggestive of mediastinal adenopathy.

5.Hepatic or renal disease as evidenced by clinical or biochemical abnormalities.

i) Serum bilirubin 1.2 mg/dl

ii) AST and ALT are 2 times the upper limit of normal

iii) AST or ALT is 4 times the upper limit of normal

iv) Blood urea or serum creatinine above the upper limit of normal (43 and 1.3 mg/dl respectively)

6.Patients with diabetes and or hypertension.

7.A history of seizure or loss of consciousness.

8.Psychiatric illness.

9.Those in a moribund state.

10.Sero-positive for HIV antibodies

11.Pregnant or lactating women

12.Female patients who refuse to adopt contraceptive practice during treatment

13.Visual disorders other than refractory error

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of the regimens in terms of <br/ ><br>a. Response at the end of treatment <br/ ><br>b. Relapse up to 24 months of follow-up after treatment <br/ ><br>in newly diagnosed superficial lymph node TB patients treated with 4-month Ofloxacin containing regimens, with the same outcome in those treated with a 6-month regimen (control regimen).Timepoint: 4 years

Secondary Outcome Measures

Name	Time	Method
To compare the incidence of <br/ ><br> a. â??Paradoxical reactionâ?? during treatment and follow <br/ ><br> b. Drug adverse reactions <br/ ><br>in newly diagnosed superficial lymph node TB patients treated with 4-month Ofloxacin containing regimens, with the same in those treated with a 6-month regimen (control regimen) <br/ ><br>Timepoint: 4 years