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AAP Grand Rounds 18:66 (2007)
© 2007 American Academy of Pediatrics
Investigators from Greece conducted a prospective, randomized, nonblinded study of children with latent tuberculosis infection (LTBI) to compare daily isoniazid (INH) monotherapy for nine months with combined daily INH and Rifampin (RIF) therapy taken for either three or four months.
A total of 926 patients <15 years of age were enrolled in one of four groups over an 8-year period. Patients were diagnosed with LTBI based on established criteria: absence of symptoms, a positive tuberculin skin test, and either a normal chest radiograph or evidence of inactive fibrotic or calcified parenchymal and/or lymph node lesions.1 Study children were followed until December 2005, three years after the last patient was enrolled. During period 1 (1995–1998), 470 patients were randomized to group A which received INH for nine months or group B which received INH and RIF for four months. In period 2 (1999–2002), 456 were randomized to group C which received INH and RIF for four months, or group D which received the same therapy for three months. Chest radiographs were performed initially, at three to four months after enrollment, and at one and three years after completion of treatment. Treatment compliance was determined by evidence of INH and RIF in the urine and clinic attendance.
There were no differences between groups enrolled during the same period in the demographic, epidemiologic (ie, identified by TB screen or contact investigation), or radiographic characteristics (ie, node vs parenchymal involvement). Compliance was rated as excellent (submitted urine tests and attended clinic appointments) or moderate (submitted urine tests and attended clinic appointments but required reminders) in 91.8% of study patients. The only significant difference in overall compliance between the four treatment groups was that patients in group B were more compliant than those in group A, P=.011.
No patient in any group developed clinical disease during the follow-up period. Among patients with excellent or moderate compliance, new radiographic findings suggestive of possible active disease were seen at four months in 48 (24%) of 200 patients in group A (INH) and 26 (11.8%) in group B (INH and RIF), P=.001. There was no difference in radiographic findings between children in groups C and D. All the children with radiographic evidence of disease were treated for TB disease and responded to treatment. No serious adverse events were seen in any of the patients. The authors conclude that short-course combined INH-RIF therapy is safe and apparently superior to nine-month INH monotherapy.
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Commentary by
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| Pediatric Infectious Diseases and Immunology, University of Florida College of Medicine, Jacksonville, FL |
The decrease in the rate of TB in the US observed since 1993 has not been as great in children as it has been in adults.2,3 Fortunately, LTBI rather than active disease is most common in children. Identifying and treating children with LTBI represents a great opportunity for TB control.4 However, compliance with the currently recommended nine months of INH therapy for LTBI and follow-up clinic visits has been problematic. Previous recommendations of a shorter course of six months of INH were withdrawn because of limited data in children and concerns about treatment failure.1,4 The authors of the current study found that the four-month course was as effective as (or superior to) the nine-month course of INH alone. They also found three- and four-month courses of INH and RIF equivalent. Although they did not directly compare a three-month course of INH and RIF to a nine-month course of INH alone, they deduced that the three-month course of INH and RIF was as good as INH monotherapy. They also found significantly poorer compliance when comparing the nine-month INH regimen versus the three- or four-month INH and RIF regimens. Short-term courses that include RIF have great potential to facilitate completion of an adequate course of therapy, especially in under-resourced parts of the world where resistant TB is prevalent.5 However, before short-course therapy with INH and RIF can be recommended, these results need to be confirmed by a large multi-center or multinational study.
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