Efficacy Study of Thrice Weekly Directly Observed Treatment Short-Course Regimen in Tubercular Pleural Effusion

NCT01560078 | Completed

• 1 other identifier: T-18012/2/2005-TB/CCD
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis; Pleural Effusion

Keywords

Tuberculosis; Pleural effusion; Category 3

Outcome Measures

Primary Outcomes (1)

• Complete resolution of pleural effusion on ultrasonogram

  Ultrasonogram to monitor pleural fluid done at baseline,2 months, 4 months and 6 months from enrollment to monitor resolution

  6 months

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with unilateral TB pleural effusion \< 1500 ml

You may not qualify if:

• Patients \< 15 years and \> 65 years were excluded
• Patients with opacity greater than four intercostal spaces in the posteroanterior (PA) chest radiograph
• Bilateral pleural effusion
• Patients who were failures/defaulters/relapses (eligible for cat II as per RNTCP guidelines)
• Sputum-smear positive cases, miliary TB, moderately advanced and far advanced parenchymal involvement on chest radiograph (eligible for cat I)
• HIV positive
• Hepatitis B surface antigen (HBsAg) positive
• Diabetes mellitus
• Refusing thoracocentesis
• Evidence of empyema
• Residence outside the study area
• Refuse to give consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Sri Venkateswara Institute of Medical Sciences University: collaborator

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Tuberculosis; Pleural Effusion

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Surendra K Sharma, MD,PhD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Department

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: September 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2012
• Last Updated: July 12, 2013

Record last verified: 2013-07

Locations

IN (1)