TuberculosisPhase 3RNTCP-DOTSNCT01124929
Treatment Duration for Abdominal Tuberculosis
A Phase 3 study testing RNTCP Category I treatment for 6 months and RNTCP Category I treatment for 9months in people with Tuberculosis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular meningitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- RNTCP Category I treatment for 6 months and RNTCP Category I treatment for 9months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2008to Apr 2014
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed patients with Intestinal TB or Peritoneal TB
- Has not received ATT for Tuberculosis any where in the body during past 5 years
- Patients having good general health and not too sick.
- Patients willing and likely to comply with the study procedures and follow up
- Patients should give informed consent.
Who cannot join
- Eighteen year is a cut off age for definition of adult and pediatric and adolescent medicine. The dosing of drugs are different in these two age groups. Therefore we plan to include patients of more than 18 years of age with abdominal TB in this study.
- Intake of ATT during the past 5 years
- Doubtful diagnosis
- Crohn's disease
- Patients with HIV and AIDS may have another systemic opportunistic infections including GI infections like cryptosporidiosis, Microsporidiosis or isosporiasis. There may be an overlap of GI manifestations such as diarrhea, abdominal pain, anemia, fever. Therefore, assessment of response to anti-tuberculosis therapy may be blurred. In order to keep the study group homogenous for comparison, we plan to exclude all those with HIV infection
- Chronic Liver Disease
Show all 11Show fewer
- Associated significant co-morbidities
- H/O Sensitivity
- Peritoneal carcinomatosis
- Patients must not been used investigational agents during the past 6 months
- Unwilling patient
Trial locations and contacts
1 site in 1 country.
India1 site
Dr Govind K Makharia
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: A Multi-centric Study on Treatment of Abdominal Tuberculosis (Intestinal or Peritoneal): A Randomized Controlled Trial to Compare the 6 Months of Cat I Treatment With 9 Months of Cat I Treatment (Extension for 3 Months) in Abdominal Tuberculosis Under the Revised National Tuberculosis Control Program
Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis use antituberculous therapy for 9 months, sometimes even 12 months without any scientific justification. In a randomized controlled trial, Balasubramaniam et al reported no difference in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy) in the treatment of abdominal tuberculosis.
Although Directly Observed Therapy (DOTs) have been proved to be effective in patients with pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis. Therefore, there is an urgent need to establish the efficacy of DOTs strategy of antituberculous therapy in the treatment of abdominal tuberculosis.
Therefore, the investigators planned to conduct a multicenter randomized controlled trial to determine the difference in the recurrence of disease after only observation for three months and three months extension of DOTs in a subset of patients with definite clinical response after 6 months of DOTs.
Read the detailed description
Rationale Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis use antituberculous therapy for 9 months, sometimes even 12 months without any scientific justification. In a randomized controlled trial, Balasubramaniam et al reported no difference in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy) in the treatment of abdominal tuberculosis.
Although DOTS have been proved to be effective in patients with pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis. The aim of the present study is not to assess the efficacy of DOTs but whether the Cat I regimen for 6 months is effective in the treatment of abdominal tuberculosis. We, therefore planned to conduct a multicenter randomized controlled trial to determine the difference in the efficacy and recurrence rate in 6months and 9 months of intermittent short course category I regimen under RNTCP.
Hypothesis There may not be a significant difference in the efficacy and recurrence rate of abdominal tuberculosis in those treated for six months vs those treated for 9 months with intermittent short course category I regimen under RNTCP.
Objectives
Primary objectives:
- To determine the efficacy of intermittent short course chemotherapy for 6 months under Directly Observed Therapy (Category I under RNTCP) in treatment of abdominal tuberculosis (proportion of patients responding to treatment)
- To determine difference in the recurrence of disease between the two randomized groups after only observation for three months and extension of RNTCP Cat I for three months in a subset of patients with definite clinical response after 6 months of DOTs Secondary objective
- To study the effect of anti-tubercular drugs on the natural history of intestinal stricture due to tuberculosis Outcomes
Outcome measures:
Primary:
- Response to treatment (6 months and nine months of RNTCP Cat I treatment) as defined earlier
- Recurrence of symptoms of abdominal tuberculosis (intestinal and peritoneal) after 1 year of follow up in those who receive 6 months or 9 months of Cat I treatment.
- Conditions
- Tuberculosis
- Being tested
- RNTCP Category I treatment for 6 months, RNTCP Category I treatment for 9months
- Keywords
- Intestinal tuberculosis, Tuberculous peritonitis, Abdominal tuberculosis
- Medical subject headings
- Tuberculosis, Peritonitis, Tuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNTCP Category I treatment for 6 monthsDrug
2H3R3Z3 E3 + 4H3R3
RNTCP Category I treatment for 9monthsDrug
2H3R3Z3 E3 + 7H3R3
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Category I treatment for 6 months | Active comparator | Anti-tuberculosis drugs Receives: Drug: RNTCP Category I treatment for 6 months |
| Arm 2: Category I treatment for 9 months | Active comparator | Anti-tuberculosis drugs, Receives: Drug: RNTCP Category I treatment for 9months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment (after 6 months and nine months of RNTCP Category I treatment)
Intestinal tuberculosis:
Complete response to treatment: Resolution of clinical manifestations, Healing of demonstrable lesions, Microbiological response (Conversion of positive to negative)
Clinical failure: Failure of response to treatment:
Persistence of clinical manifestations Persistence of morphological lesions
Peritoneal tuberculosis: Definition for response Complete response: Complete resolution of ascites within 6 months No response: Persistence of ascites
Measured: 1 year
Recurrence of symptoms of abdominal tuberculosis (intestinal and peritoneal) after 1 year of follow up in those who receive 6 months or 9 months of Cat I treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJul 2008
- Primary completionJul 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sanjay Gandhi Postgraduate Institute of Medical Sciences, Christian Medical College, Vellore, India
- Responsible party
- Principal investigator, Govind K Makharia, All India Institute of Medical Sciences
- Investigators
- Dr Govind K Makharia, MD, DM, DNB, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124929
- Sponsor's protocol ID
- Abdominal TB_RCT (RNTCP-DOTS)
- Acronym
- RNTCP-DOTS
- Status last verified
- Jul 2015
- First submitted
- 3 May 2010
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Makharia GK, Ghoshal UC, Ramakrishna BS, Agnihotri A, Ahuja V, Chowdhury SD, Gupta SD, Mechenro J, Mishra A, Mishra A, Pathak MK, Pandey RM, Sharma R, Sharma SK. Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy. Clin Infect Dis. 2015 Sep 1;61(5):750-7. doi: 10.1093/cid/civ376. Epub 2015 May 12.
PubMed 25969531
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centric Study on Treatment of Abdominal Tuberculosis (Intestinal or Peritoneal): A Randomized Controlled Trial to Compare the 6 Months of Cat I Treatment With 9 Months of Cat I Treatment (Extension for 3 Months) in Abdominal Tuberculosis Under the Revised National Tuberculosis Control Program
- ClinicalTrials.gov ID
- NCT01124929
- Acronym / sponsor ID
- RNTCP-DOTS / Abdominal TB_RCT (RNTCP-DOTS)
- Conditions
- Tuberculosis
- Keywords
- Intestinal tuberculosis, Tuberculous peritonitis, Abdominal tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Sanjay Gandhi Postgraduate Institute of Medical Sciences, Christian Medical College, Vellore, India
- Study start
- Jul 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 May 2010 (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.
Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis use antituberculous therapy for 9 months, sometimes even 12 months without any scientific justification. In a randomized controlled trial, Balasubramaniam et al reported no difference in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy) in the treatment of abdominal tuberculosis.
Although Directly Observed Therapy (DOTs) have been proved to be effective in patients with pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis. Therefore, there is an urgent need to establish the efficacy of DOTs strategy of antituberculous therapy in the treatment of abdominal tuberculosis.
Therefore, the investigators planned to conduct a multicenter randomized controlled trial to determine the difference in the recurrence of disease after only observation for three months and three months extension of DOTs in a subset of patients with definite clinical response after 6 months of DOTs.
Detailed description
Rationale Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis use antituberculous therapy for 9 months, sometimes even 12 months without any scientific justification. In a randomized controlled trial, Balasubramaniam et al reported no difference in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy) in the treatment of abdominal tuberculosis.
Although DOTS have been proved to be effective in patients with pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis. The aim of the present study is not to assess the efficacy of DOTs but whether the Cat I regimen for 6 months is effective in the treatment of abdominal tuberculosis. We, therefore planned to conduct a multicenter randomized controlled trial to determine the difference in the efficacy and recurrence rate in 6months and 9 months of intermittent short course category I regimen under RNTCP.
Hypothesis There may not be a significant difference in the efficacy and recurrence rate of abdominal tuberculosis in those treated for six months vs those treated for 9 months with intermittent short course category I regimen under RNTCP.
Objectives
Primary objectives:
- To determine the efficacy of intermittent short course chemotherapy for 6 months under Directly Observed Therapy (Category I under RNTCP) in treatment of abdominal tuberculosis (proportion of patients responding to treatment)
- To determine difference in the recurrence of disease between the two randomized groups after only observation for three months and extension of RNTCP Cat I for three months in a subset of patients with definite clinical response after 6 months of DOTs Secondary objective
- To study the effect of anti-tubercular drugs on the natural history of intestinal stricture due to tuberculosis Outcomes
Outcome measures:
Primary:
- Response to treatment (6 months and nine months of RNTCP Cat I treatment) as defined earlier
- Recurrence of symptoms of abdominal tuberculosis (intestinal and peritoneal) after 1 year of follow up in those who receive 6 months or 9 months of Cat I treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Category I treatment for 6 months | Active comparator | Drug: RNTCP Category I treatment for 6 monthsAnti-tuberculosis drugs |
| Arm 2: Category I treatment for 9 months | Active comparator | Drug: RNTCP Category I treatment for 9monthsAnti-tuberculosis drugs, |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed patients with Intestinal TB or Peritoneal TB
- Has not received ATT for Tuberculosis any where in the body during past 5 years
- Patients having good general health and not too sick.
- Patients willing and likely to comply with the study procedures and follow up
- Patients should give informed consent.
Key exclusion criteria (11 listed)
- Eighteen year is a cut off age for definition of adult and pediatric and adolescent medicine. The dosing of drugs are different in these two age groups. Therefore we plan to include patients of more than 18 years of age with abdominal TB in this study.
- Intake of ATT during the past 5 years
- Doubtful diagnosis
- Crohn's disease
- Patients with HIV and AIDS may have another systemic opportunistic infections including GI infections like cryptosporidiosis, Microsporidiosis or isosporiasis. There may be an overlap of GI manifestations such as diarrhea, abdominal pain, anemia, fever. Therefore, assessment of response to anti-tuberculosis therapy may be blurred. In order to keep the study group homogenous for comparison, we plan to exclude all those with HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNTCP Category I treatment for 6 months2H3R3Z3 E3 + 4H3R3 | Drug | Arm 1: Category I treatment for 6 months |
| RNTCP Category I treatment for 9months2H3R3Z3 E3 + 7H3R3 | Drug | Arm 2: Category I treatment for 9 months |
Primary outcome
Response to treatment (after 6 months and nine months of RNTCP Category I treatment)
Time frame: 1 year
Intestinal tuberculosis: Complete response to treatment: Resolution of clinical manifestations, Healing of demonstrable lesions, Microbiological response (Conversion of positive to negative) Clinical failure: Failure of response to treatment: Persistence of clinical manifestations Persistence of morphological lesions Peritoneal tuberculosis: Definition for response Complete response: Complete resolution of ascites within 6 months No response: Persistence of ascites
Recurrence of symptoms of abdominal tuberculosis (intestinal and peritoneal) after 1 year of follow up in those who receive 6 months or 9 months of Cat I treatment
Time frame: 1 year
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 3 Jul 2015.
- Derived from this study: PubMed 25969531Makharia GK, Ghoshal UC, Ramakrishna BS, Agnihotri A, Ahuja V, Chowdhury SD, Gupta SD, Mechenro J, Mishra A, Mishra A, Pathak MK, Pandey RM, Sharma R, Sharma SK. Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy. Clin Infect Dis. 2015 Sep 1;61(5):750-7. doi: 10.1093/cid/civ376. Epub 2015 May 12.
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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.
Dr Govind K Makharia, MD, DM, DNB 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?
A Phase 3 study testing RNTCP Category I treatment for 6 months and RNTCP Category I treatment for 9months in people with Tuberculosis, 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 5 inclusion and 11 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 3 Jul 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Response to treatment (after 6 months and nine months of RNTCP Category I treatment) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124929, which also lists 1 linked publication.
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 3 Jul 2015.