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Clinical Trials/CTRI/2013/03/003481
CTRI/2013/03/003481
Recruiting
Phase 3

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 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: null- TB Lymphadenitis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- TB Lymphadenitis
Sponsor
Indian Council of Medical Research
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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