The Effectiveness of a 9-Month Regimen of Isoniazid Alone versus 3- and 4-Month Regimens of Isoniazid plus Rifampin for Treatment of Latent Tuberculosis Infection in Children: Results of an 11-Year Randomized Study

Background. A 9-month course of isoniazid monotherapy is currently recommended for the treatment of latent tuberculosis infection (LTBI) and has been shown to be effective in both children and adults. Reduced compliance with this regimen has forced physicians to explore shorter regimens. The aim of...

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Published in:	Clinical infectious diseases Vol. 45; no. 6; pp. 715 - 722
Main Authors:	Spyridis, Nikos P., Spyridis, Panayotis G., Gelesme, Anna, Sypsa, Vana, Valianatou, Mina, Metsou, Flora, Gourgiotis, Dimitris, Tsolia, Maria N.
Format:	Journal Article
Language:	English
Published:	Chicago, IL The University Chicago Press 15-09-2007 University of Chicago Press Oxford University Press
Subjects:	Adolescent Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Antitubercular Agents - therapeutic use Articles and Commentaries Bacterial diseases Biological and medical sciences Child Child health services Child, Preschool Children Children & youth Drug therapy Drug Therapy, Combination Effectiveness studies Female Human bacterial diseases Humans Infant Infant, Newborn Infections Infectious diseases Isoniazid - therapeutic use Latent tuberculosis Lungs Male Medical sciences Mycobacterium Mycobacterium tuberculosis Patient compliance Pediatrics Pharmacology. Drug treatments Prospective Studies Rifampin - therapeutic use Time Factors Treatment compliance Treatment Outcome Tuberculosis Tuberculosis - drug therapy Tuberculosis and atypical mycobacterial infections Human Drug combination Latent tuberculosis Infection Antibiotic Rifampicin Treatment Antituberculous agent Protein synthesis inhibitor Antibacterial agent Child Isoniazid Comparative study
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Summary:	Background. A 9-month course of isoniazid monotherapy is currently recommended for the treatment of latent tuberculosis infection (LTBI) and has been shown to be effective in both children and adults. Reduced compliance with this regimen has forced physicians to explore shorter regimens. The aim of this study was to compare 3- and 4-month combination regimens of isoniazid plus rifampin with a 9-month regimen of isoniazid monotherapy for the treatment of LTBI in children. Methods. This prospective, randomized, controlled study was conducted over an 11-year period (1995–2005). In period 1 (1995–1998), 232 patients received isoniazid therapy for 9 months (group A), and 238 patients received isoniazid and rifampin for 4 months (group B). In period 2 (1999–2002), 236 patients were treated with isoniazid and rifampin for 4 months (group C), and 220 patients received the same regimen for 3 months (group D). All patients were observed for ⩾3 years. Results. Overall compliance with treatment was good, but patients who received isoniazid monotherapy were less compliant than were those who received short-course combination therapy (P = .011, for group A vs. group B; P = .510, for group C vs. group D). No patient in any group developed clinical disease during the follow-up period. New radiographic findings suggestive of possible active disease were more common in patients who received isoniazid monotherapy (24%) than in those treated with shorter regimens (11.8%, 13.6%, and 11% for groups B, C, and D, respectively; P = .001 for group A vs. group B; P = .418 for group C vs. group D). Serious drug-related adverse effects were not detected. Conclusions. Short-course treatment with isoniazid and rifampin for 3–4 months is safe and seems to be superior to a 9-month course of isoniazid monotherapy.
Bibliography:	istex:5B594F5D08E01BA1EDA5914191DF99727B55FB6E ark:/67375/HXZ-XTH19SS9-J ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Article-2 ObjectType-News-1 ObjectType-Feature-3
ISSN:	1058-4838 1537-6591
DOI:	10.1086/520983