TuberculosisNCT01560078
Efficacy Study of Thrice Weekly Directly Observed Treatment Short-Course Regimen in Tubercular Pleural Effusion
An observational study of Tuberculosis and Pleural Effusion, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Tuberculosis, Pleural Effusion
- How many people
- 360 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with unilateral TB pleural effusion < 1500 ml
Who cannot join
- 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
Show all 12Show fewer
- Hepatitis B surface antigen (HBsAg) positive
- Diabetes mellitus
- Refusing thoracocentesis
- Evidence of empyema
- Residence outside the study area
- Refuse to give consent
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Evaluation of Efficacy of Thrice Weekly DOTS Regimen in Tubercular Pleural Effusion at 6 Months
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.
Read the 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.
- Conditions
- Tuberculosis, Pleural Effusion
- Keywords
- Tuberculosis, Pleural effusion, Category 3
- Medical subject headings
- Tuberculosis, Pleural Effusion
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startSep 2006
- Primary completionOct 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sri Venkateswara Institute of Medical Sciences University
- Responsible party
- Principal investigator, S.K.SHARMA, All India Institute of Medical Sciences
- Investigators
- Surendra K Sharma, MD,PhD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560078
- Sponsor's protocol ID
- T-18012/2/2005-TB/CCD
- Status last verified
- Jul 2013
- First submitted
- 20 Mar 2012
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Thrice Weekly DOTS Regimen in Tubercular Pleural Effusion at 6 Months
- ClinicalTrials.gov ID
- NCT01560078
- Acronym / sponsor ID
- T-18012/2/2005-TB/CCD
- Conditions
- Tuberculosis, Pleural Effusion
- Keywords
- Tuberculosis, Pleural effusion, Category 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Sri Venkateswara Institute of Medical Sciences University
- Study start
- Sep 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with unilateral TB pleural effusion < 1500 ml
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete resolution of pleural effusion on ultrasonogram
Time frame: 6 months
Ultrasonogram to monitor pleural fluid done at baseline,2 months, 4 months and 6 months from enrollment to monitor resolution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surendra K Sharma, MD,PhD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Pleural Effusion, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resolution of pleural effusion on ultrasonogram (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2013.