CTRI Number |
CTRI/2015/09/006229 [Registered on: 30/09/2015] Trial Registered Retrospectively |
Last Modified On: |
30/09/2015 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Process of Care Changes |
Study Design |
Cluster Randomized Trial |
Public Title of Study
|
Direct observation of treatment provided by a family member for children with tuberculosis compared with treatment observation by non-family member in Gujarat, India |
Scientific Title of Study
Modification(s)
|
Prospective study on inclusion of the family member as a DOT provider for pediatric patients in state of Gujarat |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Paresh Dave |
Address |
Block No 5
Dr Jivraj Mehta Bhavan
Sector 10
Gandhinagar
Gandhinagar GUJARAT 382010 India |
Phone |
07923253330 |
Fax |
|
Email |
stogu@rntcp.org |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Dr Amar Shah |
Address |
Central TB Division
Room No 523 C
5th Floor
Nirman Bhavan
Moulana Azad Road
New Delhi
New Delhi DELHI 110011 India |
Phone |
8130424211 |
Fax |
|
Email |
shaha@rntcp.org |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Dr Amar Shah |
Address |
Central TB Division
Room No 523 C
5th Floor
Nirman Bhavan
Moulana Azad Road
New Delhi
New Delhi DELHI 110011 India |
Phone |
8130424211 |
Fax |
|
Email |
shaha@rntcp.org |
|
Source of Monetary or Material Support
Modification(s)
|
Study cost regarding data collection supervision & monitoring was borne by
Government Revised National Tuberculosis Control Program Gujarat India
at Following Address
State Tuberculosis Cell
Block Number 5
Jivraj Mehta Bhawan
Sector 10
Gandhinagar
PIN CODE 382010
Gujarat |
|
Primary Sponsor
Modification(s)
|
Name |
Revised National Tuberculosis Control Program |
Address |
TB Division
Commissionerate of Health
Medical Services & Medical Education
Block No 5
Dr Jivraj Mehta Bhavan
Gandhinagar-382010
Gujarat
|
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Paresh Dave |
Commissionerate of Health Medical Service & Medical Education |
Block 5
Jivraj Mehta Bhawan
Gandhingar
Gujarat Gandhinagar |
07923253330 079-23253559 stogu@rntcp.org |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
The institutional ethics committee B J Medical College & Civil Hospital Ahmedabad Gujarat |
Approved |
Ethics Advisory Committee the UNION |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Tuberculosis |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
Family Member as a DOT provider |
Family DOT is a strategy in which anti-TB medications are administered under the supervision of an adult household member.
For treatment of child (0 to 14 years) TB patient, Standard RNTCP pediatric Patient wise Box (PWB) will be used which contains 2 months of Intensive Therapy of four drugs Isoniazid, Rifampicin, Pyrazinamide and Ethambutol on alternated days orally. This will be followed by two drugs Isoniazid and Rifampicin for four months on alternate day basis. Total duration of therapy will be 6 months. The difference between the comparator agent is only who is providing the drugs. In intervention arm family member will provide the drugs to pediatric TB patient |
Comparator Agent |
Non Family Member as a DOT provider |
Non Family DOT is a strategy in which anti-TB medications are administered under the supervision of person other than a family member.
For treatment of child (0 to 14 years) TB patient, Standard RNTCP pediatric Patient wise Box (PWB) will be used which contains 2 months of Intensive Therapy of four drugs Isoniazid, Rifampicin, Pyrazinamide and Ethambutol on alternated days orally. This will be followed by two drugs Isoniazid and Rifampicin for four months on alternate day basis. Total duration of therapy will be 6 months. |
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
14.00 Year(s) |
Gender |
Both |
Details |
all children with newly diagnosed TB registered for treatment in Gujarat from June to September of 2012 under Revised National Tuberculosis Control Program |
|
ExclusionCriteria |
Details |
Children requiring hospital admission during TB treatment |
|
Method of Generating Random Sequence
|
Stratified randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Tuberculosis Treatment Success Rate
|
Six Months |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
Weight Gain at the End of TB Treatment among Children Successfully Treated for Tuberculosis |
Six Months |
|
Target Sample Size
|
Total Sample Size="566" Sample Size from India="566" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/06/2012 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Brief Summary
|
The
World Health Organization recommends direct observation of treatment (DOT) to
support patients with tuberculosis (TB) and to ensure treatment completion. As
per national programme guidelines in India, a DOT provider can be anyone who is
acceptable and accessible to the patient and accountable to the health system,
except a family member. This poses challenges among children with TB who may be
more comfortable receiving medicines from their parents or family members than
from unfamiliar DOT providers. We conducted a non-inferiority trial to assess
the effect of family DOT on treatment success rates among children with newly
diagnosed TB registered for treatment during June–September 2012.
We randomly assigned all districts (n=30) in Gujarat
to the intervention (n=15) or usual-practice group (n=15). Adult
family members in the intervention
districts were given the choice to become their child’s DOT provider. DOT
was provided by a non-family member in the usual-practice districts. Using
routinely collected clinic-based TB treatment cards,
we
compared treatment success rates (cured and treatment completed) between the
two groups and the non-inferiority
limit was kept at 5%. |