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Dr. SACHIN SONI
DNB PEDIATRICS
 Tuberculosis is caused by Mycobacterium tuberculosis
(M. bovis and M. africanum)
 Its mainly affect the lung peranchyma but can affect
other organs as well
 Children are more likely develop extrapulmonary and
severe disseminated disease as compared to adult
 Its one of the most widespread infections affecting
almost one third of the worlds population
 Globally about 1 million cases of pediatric TB are
estimated to occur every year accounting for 10-15% of
all TB cases
 In INDIA:-
1990 1995 2000 2005 2011
Number (Millions) Rate Per 100,000
Persons
Incidence
All cases (2009
WHO estimate)
2.0 (1.6-2.4) 168
Period Prevalence
(2000 estimate)
AFB positive 1.7 (1.3-2.1) 165 (126-204)
Prevalence, all cases
(2009 WHO
estimate)
3.0 (1.3-5.0) 249
The presence of three or more of the following should
strongly suggest a diagnosis of TB:
- Chronic symptoms suggestive of TB
- Physical signs highly of suggestive of TB
- A positive tuberculin skin test
- Chest X-ray suggestive of TB
 All efforts should be made to demonstrate
bacteriological evidence for diagnosis
 In cases sputum is not available, alternative specimens:-
-Gastric lavage
-Induced sputum
-Broncho-alveolar lavage
2010 2012
 Unexplained recent loss
of weight pointer to
suspicion of TB
 Static weight /not
growing well are not
significant pointer
toward diagonsis
 Loss of weight – used
as a clinical marker for
disease defined as a loss
of more than 5% of the
highest weight recorded
in the past three months
2010 2012
 Positive Tuberculin skin
test/Mantoux test:-
An induration of 10 mm
with Tuberculin 1 TU
(RT 23)
 If patient return for
reading beyond 72 h but
by 7th day positive test
can still be read
 Positive Tuberculin skin
test/Mantoux test:- An
induration of 10 mm or
more, measured 48-72
hours after Intradermal
injection with
Tuberculin 2 TU (RT 23
or equivalent) and
 No more than 5TU
(RT23 or equivalent)
should be used
 No role for inaccurate/inconsistent diagnostics test like
serology - IgM, IgG, IgA antibodies against MTB
antigens, non validated commercial PCR tests and
BCG test
 No role of IGRAs in clinical practice for
diagnosis of TB
 Lymph Node TB suspect definitions revisited and
greater clarity and updated guidance
 New case: Who has had no previous ATT or had it for
less then 2 week duration
 Failure to respond: Who fails to have bacteriological
conversion to negative status or fails to respond
clinically/or deteriorates after 12 weeks of compliant
intensive phase
 Relapse: A case of TB declared cured/completed
therapy in past and has (clinical or bacteriological)
evidence of recurrence
 Treatment after default: Who has taken treatment for at
least 4 weeks and comes after interruption of treatment
for 2 months or more and has active disease (clinical or
bacteriological
TB chemotherapy should be based on two
important microbiological considerations:
 1. The combination of drugs to avoid the
development of resistance.
 2. The need for prolonged chemotherapy to
prevent disease relapse
 All mono-therapeutic regimens (real or masked by
combination with drugs to which bacilli are resistant)
lead to treatment failure and to the development of
resistance.
 When three or more drugs are administered, the risk of
resistance is practically very low.
2012 2010
 The intermittent therapy
remain the mainstay of
treatment
 Seriously ill admitted
children or severe
disseminated disease/
neurotuberculosis, vomiting
or non-tolerance of oral drugs
is high in the initial phase
 Such, patients can be given
daily supervised therapy
during their hospital stay
 After discharge they will be
taken on thrice weekly DOT
regimen
 Tubecular bacilli exposed to
certain concentration of most
currently used ATT shows
inhibition of growth for 1 to
several days
 Intermittent thrice weekly
therapy with higher dose is as
effective as alternative
 New six weight bands (6-8,9-12,13-16,17-20,21-
24,and 25-30 kg) was created and keep them
sufficiently narrow to avoid large fluctuations at the
ends of the weight band
 Attempt to create generic boxes for each of the weight
band instead of current practice of having combine
boxes which significantly increases pill burden in
children of >18kgs
Drugs Recommended daily
doses (max doses)
mg/kg/day
Major side effects
Isoniazide (H) 10 mg/kg (max 300
mg/day)
Peripheral neuropathy,
Hepatotoxicity
Rifampicin
(R)
10-12 mg/kg (max 600
mg/day)
Hepatotoxicity, Gastitis,
Flu- like illness
Pirazinamide
(Z)
30-35 mg/kg (max 2000
mg/day)
Arthralgia,hepatotoxicity
Streptomycin
(S)
15 mg/kg (max 1g/day) Tinitus
Ethambutol
(E)
20-25 mg/kg (max 1500
mg/day)
Occulotoxicity
 Strongly recommended using dispersible tablet
formulations under the RNTCP programme
 DOT centers will be provided with pestle and mortars
for crushing the drugs
 It will be responsibility of DOT provider to supervise
process of drug consumption
 Any child vomits within half an hour of period of
observation, fresh dosages for all drugs vomited will be
provided to the caregiver
 Cat III regimen: Though, there is utility of Cat III
regimen in some pediatric TB cases
 In evidence of relatively high INH resistance i(>5%
cases) And
 Increasing evidence of safety of Ethambutol in the
doses used under RNTCP, Cat III need not be revisited
 Only two treatment categories –
Cat 1- New cases
Cat 2- Previously treated cases
 Streptomycin can be safely replaced by ethambutol in
intensive phase of TBM because:-
1- Current evidence favoring safety and efficacy of
Ethambutol
2- Lack of any value addition in efficacy using
Streptomycin over ethambutol
3- Need to avoid problems of injection based treatment
(lack of adequate muscle mass in malnourished, risks of
unsafe Injections, need for a trained personnel,
unpleasantness of the treatment).
 While ethambutol was considered a better option to
replace streptomycin in the treatment of new cases
 Streptomycin continues to be recommended as the
additional fifth drug in the retreatment
 Inadequate or no response (on smear or clinico-
radiological basis) at 8 weeks of intensive phase should
be given extension of IP for one more month
 In patients with TB Meningitis, spinal TB, miliary/
disseminated TB and osteo-articular TB, continuation
phase shall be extended by 3 months making the total
duration of treatment of 9 months
 A further extension may be done for 3 more months in
continuation phase (making the total duration of
treatment to 12 months) on a case to case basis in case
of delayed response
 RNTCP may explore and pilot test the feasibility and
effectiveness of alternate approaches like “Mother or
caregiver at home as DOT provider” in selected areas
 Currently Recommended dose of INH for chemoprophylaxis is
10 mg/kg (instead of currently recommended dosage of 5 mg/kg)
administered daily for 6 months to:-
 All asymptomatic contacts (under 6 years of age) of smear
positive case, after ruling out active disease and irrespective of
their BCG, TST or nutritional status.
 All HIV infected children who either had a known exposure to
infectious TB case or are Tuberculin skin test (TST) positive (>=5
mm induration) but have no active TB disease
 All TST positive children who are receiving immunosuppressive
therapy:-
Nephrotic syndrome, acute leukemia
 Child born to mother who was diagnosed to have TB in pregnancy
should receive prophylaxis for 6 months
 BCG vaccination can be given at birth even if INH
chemoprophylaxis is planned
THANK YOU

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Updated national guidelines for pediatric tuberculosis in india

  • 1. Dr. SACHIN SONI DNB PEDIATRICS
  • 2.  Tuberculosis is caused by Mycobacterium tuberculosis (M. bovis and M. africanum)  Its mainly affect the lung peranchyma but can affect other organs as well  Children are more likely develop extrapulmonary and severe disseminated disease as compared to adult
  • 3.  Its one of the most widespread infections affecting almost one third of the worlds population  Globally about 1 million cases of pediatric TB are estimated to occur every year accounting for 10-15% of all TB cases  In INDIA:- 1990 1995 2000 2005 2011
  • 4. Number (Millions) Rate Per 100,000 Persons Incidence All cases (2009 WHO estimate) 2.0 (1.6-2.4) 168 Period Prevalence (2000 estimate) AFB positive 1.7 (1.3-2.1) 165 (126-204) Prevalence, all cases (2009 WHO estimate) 3.0 (1.3-5.0) 249
  • 5.
  • 6. The presence of three or more of the following should strongly suggest a diagnosis of TB: - Chronic symptoms suggestive of TB - Physical signs highly of suggestive of TB - A positive tuberculin skin test - Chest X-ray suggestive of TB
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.  All efforts should be made to demonstrate bacteriological evidence for diagnosis  In cases sputum is not available, alternative specimens:- -Gastric lavage -Induced sputum -Broncho-alveolar lavage
  • 13. 2010 2012  Unexplained recent loss of weight pointer to suspicion of TB  Static weight /not growing well are not significant pointer toward diagonsis  Loss of weight – used as a clinical marker for disease defined as a loss of more than 5% of the highest weight recorded in the past three months
  • 14. 2010 2012  Positive Tuberculin skin test/Mantoux test:- An induration of 10 mm with Tuberculin 1 TU (RT 23)  If patient return for reading beyond 72 h but by 7th day positive test can still be read  Positive Tuberculin skin test/Mantoux test:- An induration of 10 mm or more, measured 48-72 hours after Intradermal injection with Tuberculin 2 TU (RT 23 or equivalent) and  No more than 5TU (RT23 or equivalent) should be used
  • 15.  No role for inaccurate/inconsistent diagnostics test like serology - IgM, IgG, IgA antibodies against MTB antigens, non validated commercial PCR tests and BCG test  No role of IGRAs in clinical practice for diagnosis of TB  Lymph Node TB suspect definitions revisited and greater clarity and updated guidance
  • 16.
  • 17.  New case: Who has had no previous ATT or had it for less then 2 week duration  Failure to respond: Who fails to have bacteriological conversion to negative status or fails to respond clinically/or deteriorates after 12 weeks of compliant intensive phase  Relapse: A case of TB declared cured/completed therapy in past and has (clinical or bacteriological) evidence of recurrence  Treatment after default: Who has taken treatment for at least 4 weeks and comes after interruption of treatment for 2 months or more and has active disease (clinical or bacteriological
  • 18. TB chemotherapy should be based on two important microbiological considerations:  1. The combination of drugs to avoid the development of resistance.  2. The need for prolonged chemotherapy to prevent disease relapse
  • 19.  All mono-therapeutic regimens (real or masked by combination with drugs to which bacilli are resistant) lead to treatment failure and to the development of resistance.  When three or more drugs are administered, the risk of resistance is practically very low.
  • 20. 2012 2010  The intermittent therapy remain the mainstay of treatment  Seriously ill admitted children or severe disseminated disease/ neurotuberculosis, vomiting or non-tolerance of oral drugs is high in the initial phase  Such, patients can be given daily supervised therapy during their hospital stay  After discharge they will be taken on thrice weekly DOT regimen  Tubecular bacilli exposed to certain concentration of most currently used ATT shows inhibition of growth for 1 to several days  Intermittent thrice weekly therapy with higher dose is as effective as alternative
  • 21.  New six weight bands (6-8,9-12,13-16,17-20,21- 24,and 25-30 kg) was created and keep them sufficiently narrow to avoid large fluctuations at the ends of the weight band  Attempt to create generic boxes for each of the weight band instead of current practice of having combine boxes which significantly increases pill burden in children of >18kgs
  • 22. Drugs Recommended daily doses (max doses) mg/kg/day Major side effects Isoniazide (H) 10 mg/kg (max 300 mg/day) Peripheral neuropathy, Hepatotoxicity Rifampicin (R) 10-12 mg/kg (max 600 mg/day) Hepatotoxicity, Gastitis, Flu- like illness Pirazinamide (Z) 30-35 mg/kg (max 2000 mg/day) Arthralgia,hepatotoxicity Streptomycin (S) 15 mg/kg (max 1g/day) Tinitus Ethambutol (E) 20-25 mg/kg (max 1500 mg/day) Occulotoxicity
  • 23.
  • 24.
  • 25.  Strongly recommended using dispersible tablet formulations under the RNTCP programme  DOT centers will be provided with pestle and mortars for crushing the drugs  It will be responsibility of DOT provider to supervise process of drug consumption  Any child vomits within half an hour of period of observation, fresh dosages for all drugs vomited will be provided to the caregiver
  • 26.  Cat III regimen: Though, there is utility of Cat III regimen in some pediatric TB cases  In evidence of relatively high INH resistance i(>5% cases) And  Increasing evidence of safety of Ethambutol in the doses used under RNTCP, Cat III need not be revisited  Only two treatment categories – Cat 1- New cases Cat 2- Previously treated cases
  • 27.
  • 28.
  • 29.  Streptomycin can be safely replaced by ethambutol in intensive phase of TBM because:- 1- Current evidence favoring safety and efficacy of Ethambutol 2- Lack of any value addition in efficacy using Streptomycin over ethambutol 3- Need to avoid problems of injection based treatment (lack of adequate muscle mass in malnourished, risks of unsafe Injections, need for a trained personnel, unpleasantness of the treatment).  While ethambutol was considered a better option to replace streptomycin in the treatment of new cases  Streptomycin continues to be recommended as the additional fifth drug in the retreatment
  • 30.  Inadequate or no response (on smear or clinico- radiological basis) at 8 weeks of intensive phase should be given extension of IP for one more month  In patients with TB Meningitis, spinal TB, miliary/ disseminated TB and osteo-articular TB, continuation phase shall be extended by 3 months making the total duration of treatment of 9 months  A further extension may be done for 3 more months in continuation phase (making the total duration of treatment to 12 months) on a case to case basis in case of delayed response
  • 31.  RNTCP may explore and pilot test the feasibility and effectiveness of alternate approaches like “Mother or caregiver at home as DOT provider” in selected areas
  • 32.  Currently Recommended dose of INH for chemoprophylaxis is 10 mg/kg (instead of currently recommended dosage of 5 mg/kg) administered daily for 6 months to:-  All asymptomatic contacts (under 6 years of age) of smear positive case, after ruling out active disease and irrespective of their BCG, TST or nutritional status.  All HIV infected children who either had a known exposure to infectious TB case or are Tuberculin skin test (TST) positive (>=5 mm induration) but have no active TB disease  All TST positive children who are receiving immunosuppressive therapy:- Nephrotic syndrome, acute leukemia  Child born to mother who was diagnosed to have TB in pregnancy should receive prophylaxis for 6 months  BCG vaccination can be given at birth even if INH chemoprophylaxis is planned