National guidelines on diagnosis and treatment of Pediatric Tuberculosis

The National guidelines on Pediatric TB diagnosis and management were updated based on the recent evidence and advances in Pediatric TB diagnosis and treatment in consultation with Indian Academy Pediatrics.

Diagnosis of Pediatric TB (0-14 years)

The diagnostic algorithms for the diagnosis of pulmonary TB and Lymph node tuberculosis are provided in Annexure 1 of the detailed guidelines.

1. All efforts should be made to demonstrate bacteriological evidence in the diagnosis of pediatric TB. In cases where sputum is not available for examination or sputum microscopy fails to demonstrate AFB, alternative specimens (Gastric lavage ,Induced sputum, broncho-alveolar lavage) should be collected, depending upon the feasibility, under the supervision of a pediatrician.
2. A positive Tuberculin skin test / Mantoux positive were defined as 10mm or more induration. The optimal strength of tuberculin 2 TU(RT 23 or equivalent) to be used for diagnosis in children.
• There is no role for inaccurate/inconsistent diagnosis like serology (lgM, lgG, IgA antibodies against MTB antigens), various in-house or non-validated commercial PCR tests and BCG test.
• There is no role of IGRAs in clinical practice for the diagnosis of TB.
3. Loss of weight was defined as a loss of more than 5% of the highest weight recorded in the past three months.

Intermittent versus Daily regimen

The intermittent therapy will remain the mainstay of treating pediatric patients. However, among seriously ill admitted children or those with severe disseminated disease /neuro-tuberculosis, the likelihood of vomiting or non-tolerance of oral drugs is high in the initial phase. Such, select group of seriously ill admitted patients should be given daily supervised therapy during their stay in the hospital using daily drug dosages. After discharge they will be taken on thrice weekly DOT regimen (with suitable modification to thrice weekly dosages). The following are the daily doses (mg per kg of body weight per day) Rifampicin 10-12 mg/kg (max 600 mg/day), Isoniazid 10 mg/kg (max 300 mg/day), Ethambutol 20-25 mg/kg (max 1500 mg/kg), PZA 30-35 mg/kg (max 2000mg/day) and Streptomycin15 mg/kg (max 1 gm/day).

Case Definitions

The following newer Case Definitions for pediatric TB Patients will be incorporated in the RNTCP manuals

1. Failure to respond : A case of pediatric TB who fails to have bacteriological conversion to negative status or fails to respond clinically/ or deteriorates after 12 weeks of compliant intensive phase shall be deemed to have failed response provided alternative diagnosis/reasons for non-response have been ruled out.
2. Relapse : A case of pediatric TB declared cured/completed therapy in past and has (clinical or bacteriological ) evidence of recurrence.
3. Treatment after default : A case of pediatric TB who has taken treatment for atleast 4 weeks and comes after interruption of treatment for 2 months or more and has active disease (clinical and bacteriological).
4. For programmatic purposes of reporting, all types of retreatment cases where bacteriological evidence could not be demonstrated but decision to treat again was taken on clinical grounds would continue to be recorded and reported as "OTHERS" for surveillance purposes.

Drug dosages

1. There will be six weight bands and three generic patient wise boxes will be used in combination to treat patients in the six weight bands. The details of the new weight bands and the new generic boxes are provided in the Annexure 2 (Table 1) of the detailed guidelines. Since,it would take at-least 2 years for supply of these products under RNTCP. An interim guidance to optimize the use of the existing patient wise boxes and align them as much as possible to the new dosing recommendations has been developed and its provided in Annexure 2 (Table 2) of the detailed guidelines.
2. To ensure that child get correct dosages, weighing of the patient int minimal clothing (as appropriate) using accurate weighing scales is essential.
3. All pediatric TB patients should be shifted to next weight band if a child gains a kilogram or more, above the upper limit of the existing weight band.

Drug formulations

Since, the number of tablets is too many to consume and younger patients have difficulty in swallowing tablets the DOT centers will be provided with pestle and mortars for crushing the drugs. It will be the responsibility of the DOT provider to supervise the process of drug consumption by the child and in any case any child vomits within half an hour of period of observation, fresh dosages for all the drugs vomited will be provided to the caregiver.

Treatment regimens

There will be only two treatment categories - one for treating 'new' cases and another for treating 'previously treated cases'. The treatment regimens are summarized in Annexure 2 (Table 3) of the detailed guidelines.

TB Meningitis

During intensive phase of TB Meningitis, Injection Streptomycin is to replaced by Tablet Ethambutol.

Extending intensive and continuation phase

1. Children who show poor or no response at 8 weeks of intensive phase should be given benefit if extension of IP for one more month.
2. In patients with TB Meningitis, spinal TB, miliary / disseminated TB and osteo-articular TB, the continuation phase shall be extended by 3 months making the total duration of the treatment to a total of 9 months. A further extension may be done for 3 months in continuation phase (making the total duration of treatment to 12 months) on a case to case basis in case of delayed response and as per the discretion of the treating physician/ pediatrician.

TB preventive therapy

The dose of INH for chemoprophylaxis is 10 mg/kg (instead of currently recommended dosage of 5 mg/kg) administered daily for 6 months. TB preventive therapy should be provided to:

1. All asymptomatic contacts (under 6 years of age) of a smear positive case, after ruling out active disease and irrespective of their BCG or nutritional status.
2. Chemoprophylaxis is also recommended for all HIV infected children who either had a known exposure to an infectious TB case or are Tuberculin skin test (TST) positive (>= 5mm induration) but have no active TB disease.
3. All TST positive children who are receiving immunosuppressive therapy (e.g. Children with nephrotic syndrome, acute leukemia, etc.).
4. A Child born to mother who has diagnosed to have TB in pregnancy should receive prophylaxis for 6 months, provided congenital TB has been ruled out. BCG vaccination can be given at birth even if INH chemoprophylaxis is planned.

Source : Central TB Division, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India

Related Resources

1. Operational Guidelines for TB services at Health & Wellness Centres
2. Guidelines on Programmatic. Management of Drug Resistant TB (PMDT) in India 2021
3. New fixed-dose combinations for the treatment of TB in children