Treating BCG-induced disease in children

• Published in: Cochrane database of systematic reviews 2013-01, Vol.2013 (1), p.CD008300
• Main Authors: Cuello-García, Carlos A, Pérez-Gaxiola, Giordano, Jiménez Gutiérrez, Carlos
• Format: Article
• Language: English
• Subjects: Abscess - microbiology; Abscess - therapy; Adjuvants, Immunologic - adverse effects; Antibiotics, Antitubercular - therapeutic use; BCG Vaccine - adverse effects; Child; Child, Preschool; Erythromycin - therapeutic use; Humans; Infant; Isoniazid - therapeutic use; Lymphadenitis - microbiology; Lymphadenitis - therapy; Medicine General & Introductory Medical Sciences; Mycobacterium bovis; Randomized Controlled Trials as Topic; Rifampin - therapeutic use; Suction - methods
• ISSN: 1469-493X
• DOI: 10.1002/14651858.CD008300.pub2

Bacillus Calmette-Guerín (BCG) is a live attenuated vaccine to prevent tuberculosis, routinely administered at birth as part of the World Health Organization global expanded immunisation programme. Given intradermally, it can cause adverse reactions, including local, regional, distant and disseminated manifestations that may cause parental distress. Rarely, it can cause serious illness and even death. Among those patients with immunocompromised conditions, such as the human immunodeficiency virus (HIV) infection, the complication rate is even higher. To assess the effects of different interventions for treating BCG-induced disease in children. The following databases were searched: the Cochrane Infectious Diseases Group Specialized Register and Cochrane Central Register of Controlled Trials (CENTRAL), published in The Cochrane Library (The Cochrane Library 2012, Issue 4); MEDLINE (1966 to November 2012); EMBASE (1947 to November 2012); and LILACS (1980 to November 2012). The metaRegister of Controlled Trials (mRCT) and the WHO trials search portal. Conference proceedings for relevant abstracts and experts were also contacted to identify studies. No language restrictions were applied. Randomized controlled trials (RCTs) comparing any medical or surgical treatment modality for BCG-induced disease in children. Two authors independently evaluated titles, applied inclusion criteria, and assessed the risk of bias of studies. The primary outcomes were the failure rate of therapies for all types of BCG vaccine-induced complications and the time to resolution of illness measured in months. The secondary outcomes were death from BCG vaccine-induced disease and the all-cause mortality. Risk ratios (RRs) were used as measure of effect for dichotomous outcomes and mean differences for continuous outcomes. Five RCTs analysing 341 children addressed the primary outcomes and were included. Four arms compared oral antibiotics to no intervention or placebo, one arm evaluated needle aspiration compared to no intervention, and another evaluated the use of locally instilled isoniazid versus oral erythromycin.Two small studies evaluated oral isoniazid; we are uncertain of whether this intervention has an effect on clinical failure (RR 1.48; 95% Confidence Interval (CI) 0.79 to 2.78; 54 participants, two studies, very low quality evidence). Similarly, for oral erythromycin, we are uncertain if there is an effect (clinical failure RR 1.03; 95% CI 0.70 to 1.53; 148 participants, t