Latency in Pulmonary Tuberculosis

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The immune responses in latent tuberculosis are poorly understood. While it is difficult to define the onset of latency during natural infection, patients undergoing treatment for tuberculosis are driven into a state of latency or cure. The present study on the effect of 3 and 4 month regimens containing moxifloxacin in sputum smear and culture positive pulmonary tuberculosis (TRC Study number 24) offers us the opportunity to study definitive immune responses pre and post treatment. We will evaluate a variety of innate and adaptive immune responses in patients before and after treatment and our study will compare the differences in immuno-phenotype (eg. Markers of T, B and NK cell activation, proliferation and regulatory phenotype) and function (eg. Production of cytokines, proliferative responses to TB antigens) at different time points following treatment. In addition, since a small percentage of patients will undergo relapse following treatment, the kinetics of immune responses in these patients will used to assess immunological predictors of relapse in tuberculosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuberculosis Research Centre, India
• Collaborator: National Institutes of Health (NIH)
• Treatments: Ethambutol; Fluoroquinolones; Isoniazid; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

• Age 18 years and above

• Residing in or around Chennai or Madurai

• 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 before enrollment in the study)

• At least two sputum smears should be positive for tubercle bacilli by fluorescent microscopy

• Express willingness to attend the treatment centre for supervised treatment

• Express willingness for home visits by the staff of the centre

• Express willingness to give written informed consent

Exclusion Criteria:

• Body weight less than 30 kg

• Hepatic or renal disease as evidenced by clinical or biochemical abnormalities

• Diabetes mellitus

• A history of seizure or loss of consciousness

• Psychiatric illness

• An abnormal electrocardiogram or anti-arrhythmic medication

• Those in a moribund state

• Sero-positive for HIV antibodies

• Pregnancy or lactation

• Visual disorders other than refractory error