Latest In Childhood Tuberculosis Management According To RNTCP Approved by IAP
Dr. Prof. N. L. Phuljhele (M.D.)*
Prof & Head of Department, Department of Pediatrics, Dr. B.R.A.M. Hospital, Raipur (C.G.) *
EPIDEMIOLOGY
It has been assumed that 10% of the total TB cases are found amongst children. Global estimates of 1.5 million new cases and 130,000 deaths due to TB per year amongst children are reported. However, these figures appear to be an underestimate of the size of the problem. Kochi A: The global tuberculosis situation and the new control strategy of the World Health Organization. Tubercle 1991;72:1. World Health Organization (WHO). WHO report on the Tuberculosis epidemic. Geneva: WHO;1996.
Childhood TB Prevalence indicates
  • Community prevalence of sputum smear positive pulmonary tuberculosis (PTB)
  • Age-related prevalence of sputum smear positive PTB
  • Prevalence of childhood risk factors for disease
  • Stage of epidemic

Proper identification and treatment of infectious cases will prevent childhood TB. However often childhood TB is accorded low priority by National TB Control Programmes in Children.
Probable reasons include
  • Diagnostic difficulties
  • Rarely infectious
  • Limited resources
  • Misplaced faith in BCG
  • Lack of data on treatment

But this disregards the impact of tuberculosis on childhood morbidity and mortality. Children can present with TB at any age, but the majority of cases present between age of 1 and 4 years. Disease usually develops within one year of infection - the younger, the earlier and the more disseminated. The PTB prevalence is normally low between the ages of 5 and 12 years, and then increases in adolescence when PTB manifests like adult PTB (post primary tuberculosis)3. PTB in children is usually smear negative. Pulmonary to extra-pulmonary TB (EPTB) ratio is around 3:1.
Treatment of Childhood Tuberculosis
Consensus statement of IAP working Group Indian Pediatric 1997;34:1093-1096. In order to optimize treatment protocol, tuberculosis is classified into 5 groups based on clinical types. The suggested regimen for drug therapy in each of these groups is as follows:
GROUP 1 (PREVENTIVE THERAPY)
Asymptomatic Mantoux positive < 3 years
Asymptomatic Mantoux positive <5 years with Grades 3 or 4 malnutrition
Mantoux +ve - Recent converter/no signs
Children <3 years with H/O +ve contact
Children <5 years - Grades 3 or 4 malnutrition with H/O +ve contact

Treat with 6 months of INH and Rifampicin.

GROUP 2

Primary Complex (lung)
Symptomatic Mantoux +ve <3 years without localization
Symptomatic Mantoux +ve <5 years with Grades 3 or 4 malnutrition without localization
Isolated lymphadenitis
Pleural effusion

Treat with 2 months of INH, Rifampicin and Pyrazanamide followed by 4 months of INH and Rifampicin.

GROUP 3
Progressive pulmonary disease
Tubercular lymphadenitis - Multiple
Treat 2 months of INH, Rifampicin, Pyrazinamide and Ethambutol followed by 4 months of INH and Rifampicin Continuation phase extended by 3 months in event of non-resolution.

GROUP 4
Miliary/Disseminated disease
Cavitatory disease/Bronchopneumonia
Osteoarticular disease
Abdominal, Pericardial, Genitourinary disease
Treat with 2 months of INH, Rifampicin, Pyrazinamide and Ethambutol followed by 7 months of INH and Rifampicin.

GROUP 5
Neuro-tuberculosis

Treat with 2 months INH, Rifampicin, Pyrazinamide and Ethambutol followed by 10 months of INH, Rifampicin and Ethambutol.

Dosage Recommendations:

Isoniazid - 5 mg/kg (to be rounded to the closest higher dose)
Rifampicin - 10 mg/kg
Pyrazinamide - 25 mg/kg
Ethambutol - 20 mg/kg
Streptomycin - 20 mg/kg
Prednisolone - 1-2 mg/kg

All the drugs should be administered in a single daily dose on an empty stomach.

Indications for Prednisolone: Neurotuberculosis, Miliary tuberculosis, Tuberculosis involving serous layers, Endobronchial tuberculosis, Genito-urinary tuberculosis / sinus formation.
Treatment
During the last few years dramatic changes have occurred in the therapeutic approaches to childhood TB as a result of large number of treatment trials for children and increased concern about the development of resistance to antituberculosis drugs. Short-course chemotherapy, with the treatment duration as short as 6 months, has become the standard practice. Intermittent regimens have been documented to be as effective as daily regimen in the paediatric population. Biddulph J. Short-course chemotherapy for childhood tuberculosis. (Ped.Inf Dis J 1990;9:794-801, Dr. Perkins et al, twice weekly vs daily chemotherapy for childhood tuberculosis. Ped. Inf Dis J 2000;19:405-410).
REVISED NATIONAL TB CONTROL PROGRAMME
India has had a National Tuberculosis programme (NTP) in operation since 1962. In 1992, a joint Government of India / World Health Organization review found that despite the existence of the NTP TB patients were not being accurately diagnosed and that the majority of diagnosed did not complete treatment. Based on the recommendations of the review, the Revised National TB Control Programme (RNTCP), incorporating the internationally recommended DOTS strategy, was developed. In 1993, RNTCP was started in pilot areas covering a population of 18 million. Large-scale implementation of the RNTCP began in 1998, with a World Bank credit of Rs.604 crore.
Treatment Guidelines as per WHO for National Programme
The DOTS strategy is applicable to all patients with tuberculosis, including children. High success rates (over 95%) are achievable in children with PTB and less severe forms of EPTB such as TB lymphadenopathy. Thioacetazone can cause severe and often fatal reactions in HIV-endemic regions. It has been replaced by ethambutol. There has been understandable caution with the use of ethambutol in children too young to report early visual deterioration, but ethambutol has been safely used in infants and young children at recommended dosages.

Directly observed therapy short-course (DOTS) has been successfully used in adults but there are no studies in children. An observational trial evaluated directly observed therapy 6-month regimen for pulmonary, pleural and lymph node tuberculosis in children. This regimen showed results comparable with those of 6-month regimens with longer durations of daily therapy. Starke J R et al, Ped. Inf Dis J 2002;21:91-97.

The major problem in inclusion of children in DOTS is difficulty in demonstration of AFB and classification of different clinical manifestations according to categories described for adults. A classification was developed and evaluated in the tuberculosis clinic of a tertiary care hospital. (Kabra S K ; Seth V et al. Category based treatment of tuberculosis in children. Indian Pediatric 2004;41:927-37).

The authors concluded that it is feasible to classify and manage various types of tuberculosis in children in different categories similar to WHO guidelines for adult tuberculosis (Kabra S K; Seth V et al. Category based treatment of tuberculosis in children. Indian Pediatric 2004;41:927-37).

Recently a consensus statement jointly prepared by Indian Academy of Pediatrics and Revised National Tuberculosis Control Program 9RNTCP) has also proposed a classification of different types of tuberculosis in children into three categories (Chauhan L S, Arora V K et al. Management of Pediatric Tuberculosis Under the Revised National Tuberculosis Control Programme, Indian Pediatrics 2004;41:901-906
Management of Pediatric Tuberculosis Under the Revised National Tuberculosis Control Programme
DOTS is the recommended strategy for treatment of TB and all Pediatric TB and all Pediatric TB patients should be registered under RNTCP. Recommended treatment regimens are given in [Table - 1]:

Category of Treatment Type of Patients TB treatment regime
    Intensive Phase Continuation Phase
Category I
  • New sputum smear positive PTB
  • Seriously ill sputum smear negative PTB with extensive parenchymal involvement (acute military, segmental/lobar opacity)
  • Seriously ill extra-pulmonary TB includes disseminated/military TB, TB pericarditis, TB peritonitis and intestinal TB, bilateral or extensive pleurisy, genitor-urinary tract TB, bone and joint TB.
2H3R3Z3E3

4H3R3

Category I

  • CNS TB (meningitis, tuberculoma of brain, spinal TB with or without neurological complications and other part of nervous system)

2H3R3Z3S3

6-7H3R3

Category II

  • Sputum smear-positive relapse, (with evidence of tubercular features)
  • Sputum smear-positive treatment failure, (with evidence of tubercular features)
  • Sputum smear-positive treatment after default, (with evidence of tubercular features)

2S3H3R3Z3E3/

1 H3R3Z3E3

5 H3R3E3

Category III

  • Sputum smear-negative and Extra-pulmonary TB, not seriously ill (TB adenitis, mediastinal lymphadenopathy, skin TB and not seriously ill abdominal TB)

2H3R3Z3

4H3R3



The drug dosages per kilogram are the same for children and adults.

Essential Anti-tuberculosis drugs:

Essential drugs

Recommended dosages in mg/kg

Daily

3 times weekly

Isoniazid (H)

5 (4-6)

10 (8-12)

Rifampicin ®

10 (8-12)

10 (8-12)

Pyrazinamide (Z)

25 (20-30)

35 (30-40)

Streptomycin (S)

15 (12-18)

15 (12-18)

Ethambutol (E)

15 (15-20)

30 (20-35)

Thioacetazone (T)

2.5

Not applicable




WHO does not recommend twice weekly regime
  1. In children's with TBM streptomycin (or ethionamide) should be used instead of ethambutol because it does not cross blood brain barrier.
  2. Corticosteroids may sometimes useful in TBM or in lobar/segmental opacity due to lymphadenopathy, Miliary tuberculosis, Tuberculosis involving serous layers, Endobronchial tuberculosis, sinus formation.
  3. Effectiveness of ethambutol in maintenance or continuation phase never been studied in children's whereas Rifampicin and Isoniazid proven efficacy.
  4. Anti-tubercular drugs available here in following strength:


Anti-tubercular drugs

Strength

Isoniazid (H)
Rifampicin (R )
Pyrazinamide (Z)
Ethambutol (E)
100 mg
150 mg
500 mg
800 mg


  1. All Anti-tubercular drugs are available in loose form at DOTS centre for RNTCP.
  2. To assist in calculating required dosages and administration of anti-TB drugs for children, the medication may be made available in the form of combopacks in patient wise-boxes, linked to the child's weight.
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