Efficacy Study of Thrice Weekly Directly Observed Treatment Short-Course Regimen in Tubercular Pleural Effusion
Condition: Tuberculosis; Pleural Effusion
MeSH terms: Tuberculosis; Pleural Effusion
Study type: Observational

Summary: 
      Tubercular pleural effusion is the second most common form of extrapulmonary tuberculosis
      (EPTB) seen in clinical practice after tuberculosis (TB) lymphadenitis. It is common that
      after complete treatment of the patient with tubercular pleural effusion with six months of
      the short-course chemotherapy under Directly Observed Treatment Short-Course (DOTS), pleural
      effusion has not resolved completely. In these cases treatment need to be extended for one or
      two more months by giving extension pouches.

      Since DOTS does not recommend demonstration of complete resolution of tubercular pleural
      effusion at the end of treatment completion, there is paucity of data in terms of the
      patients declared cure for the sputum negative pulmonary and extra-pulmonary TB as such which
      includes TB pleural effusion as well. This project aims to look into the patient
      characteristics, treatment outcome, and compute the number of cases which require an extended
      regimen and to what extent is the pleural effusion persistent at the end of six months of
      standard DOTS therapy.
    

Detailed description: 
      India's Revised National Tuberculosis Control Programme (RNTCP), based on Directly Observed
      Treatment Short-Course (DOTS) strategy, began as a pilot project in 1993 and was launched as
      a national program in 1997. Three categories of treatment were recommended based on disease
      characteristics. Category III regimen comprised of thrice-weekly isoniazid, rifampicin and
      pyrazinamide in the intensive phase; with isoniazid and rifampicin in the continuation phase.
      This regimen was recommended for sputum smear negative and extrapulmonary tuberculosis (TB)
      patients who were not seriously ill. The omission of ethambutol in non-cavitary,
      smear-negative pulmonary TB patients who were known to be human immunodeficiency virus (HIV)
      negative was endorsed by the World Health Organization (WHO) guidelines. However, in view of
      high level of initial resistance to isoniazid in many areas, recent guidelines recommend
      adding ethambutol in the intensive phase, effectively eliminating category III.

      This study was designed as a multicentre, longitudinal observational study and was carried
      out between 2006 and 2011. Three hundred and sixty patients were planned to be enrolled
      across 4 centres, namely AIIMS (New Delhi), SMS Medical College (Jaipur), SVIMS (Tirupati)
      and BJ Medical College (Ahmedabad); i.e. 90 patients at each centre. Lost to
      follow-up/default rate of 12% was expected in the study. Recruitment was done from the study
      sites directly as well as from referrals via nearby DOTS centres, hospitals and chest
      clinics.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1042 patients presenting with unilateral tubercular pleural effusion who attended DOTS
        Centres/Chest clinics at the respective Study sites between the ages 15 and 65 years were
        screened for the study.351 were enrolled after 691 were excluded due to various reasons.
      
Keywords: Tuberculosis; Pleural effusion; Category 3