Updated national guidelines for pediatric tuberculosis in india

UPDATED NATIONAL GUIDELINES FOR PEDIATRIC

TUBERCULOSIS IN INDIA 2012

Dr. SACHIN SONI

DNB PEDIATRICS

INTRODUCTION

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

EPIDEMIOLOGY 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

INCIDENCE AND PREVALANCE IN INDIA

Number (Millions) Rate Per 100,000Persons

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

COMPARATIVE DIAGNOSTIC ALGORITHM OF TB

KEY FEATURES SUGGESTIVE OF TB

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

DIAGNOSTIC ALGORITHM FOR PULMONARY TUBERCULOSIS 2010

DIAGNOSTIC ALGORITHM FOR TUBERCULAR LYMPHADENITIS 2010

DIAGNOSTIC ALGORITHM FOR PEDIATRIC PULMONARY TUBERCULOSIS 2012

CONTINUE….

DIAGNOSTIC ALGORITHM FOR DIAGNOSIS OF LYMPH NODE TUBERCULOSIS

RECOMMENDATIONS

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

CONTINUE…. 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

EXTRA-PULMONARY TB

CASE DEFINITIONS

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

TREATMENT

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

CONTINUE….

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.

INTERMITTENT VERSUS DAILY REGIMEN

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

DRUG DOSAGES

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

2012

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

NEW WEIGHT BANDS AND GENERIC PATIENT WISE BOXES

REVISED DOSING AND WEIGHT BANDS ACCORDING TO EXISTING PEDIATRIC PATIENT WISE BOXES (PWB)

DRUG FORMULATIONS 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

TREATMENT CATEGORIES AND REGIMENS 2010

TREATMENT CATEGORIES AND REGIMENS 2012

TB MENINGITIS

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

EXTENDING INTENSIVE AND CONTINUATION PHASE 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

MAKING DOT PATIENT FRIENDLY

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

PREVENTIVE THERAPY 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