title: Efficacy, safety, and tolerability of a 24-month treatment regimen including delamanid in a child with extensively drug-resistant tuberculosis: A case report and review of the literature.
abstract: BACKGROUND
  Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) are emerging problems in several countries. These infections require long and expensive treatment regimens. Recently, 2 new drugs, bedaquiline and delamanid, have been approved in several countries for use in adults with severe, difficult-to-treat MDR-TB, and it has been suggested that they could also be administered to children with MDR-TB and limited treatment options. However, no study has been completed on their efficacy.
  
  
  METHODS
  This report describes a 12-year-old child with XDR-TB who was cured after a 24-month therapy regimen, which included delamanid.
  
  
  METHODS
  The patient showed progressive clinical deterioration after 5 months of treatment with the majority of anti-TB drugs available on the market.
  
  
  METHODS
  After unsuccessfull treatment with several anti-TB drugs for 5 months, he was treated with a regimen including for 24 months.
  
  
  RESULTS
  Direct smear microscopy of the gastric aspirates and gastric aspirate cultures for Mycobacterium tuberculosis became negative after only 1 week and remained persistently negative. During the 24-month treatment, all blood test results remained within the normal range, no adverse events were reported, and corrected QT interval was always normal. A clinical and laboratory control was performed 3 months after discontinuation of delamanid, and the other drugs did not reveal any modification of both general conditions as well as laboratory and radiological findings. The patient was considered cured.
  
  
  CONCLUSIONS
  The positive outcome associated with the favorable safety and tolerability profile showed that long-term therapy with delamanid can significantly contribute to treating apparently hopeless XDR-TB cases in children.
authors.affiliation: Department of Pathophysiology and Transplantation, Pediatric Highly Intensive Care Unit, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan Department of Medical and Surgical Sciences, Unit of Infectious Diseases, Alma Mater Studiorum University of Bologna, Bologna World Health Organization Collaborating Centre for TB and Lung Diseases, Fondazione S. Maugeri, Tradate, Italy.
authors.forename: Susanna
authors.initials: S
authors.lastname: Esposito
authors.forename: Samantha
authors.initials: S
authors.lastname: Bosis
authors.forename: Marina
authors.initials: M
authors.lastname: Tadolini
authors.forename: Sonia
authors.initials: S
authors.lastname: Bianchini
authors.forename: Giovanni Battista
authors.initials: GB
authors.lastname: Migliori
authors.forename: Nicola
authors.initials: N
authors.lastname: Principi
mesh_terms: D000995:Antitubercular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004359:Drug Therapy, Combination; D054908:Extensively Drug-Resistant Tuberculosis / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007558:Italy; D008297:Male; D009593:Nitroimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D010080:Oxazoles / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000995:Antitubercular Agents; D009593:Nitroimidazoles; C516022:OPC-67683; D010080:Oxazoles