RANDOMISED CLINICAL TRIAL TO STUDY THE EFFICACY AND TOLERABILITY OF A 4-MONTH REGIMEN CONTAINING OFLOXACIN COMPARED TO THE STANDARD 6-MONTH REGIMEN IN THE TREATMENT OF PATIENTS WITH SUPERFICIAL LYMPH NODE TUBERCULOSIS - TB

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•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.

•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

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