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Table 1 Clinical and radiological/laboratory criteria required to make a diagnosis of confirmed, probable or possible TB in child TB contacts aged < 5 years of age. Developed in collaboration with the trial teams from V-QUIN and PHOENIx

From: Levofloxacin versus placebo for the prevention of tuberculosis disease in child contacts of multidrug-resistant tuberculosis: study protocol for a phase III cluster randomised controlled trial (TB-CHAMP)

Clinical (A) Radiological/laboratory (B)
• Cough or cervical neck mass (≥2 × 2 cm) for > 2 weeks despite a course of antibiotics
• Fever or lethargy for > 1 week despite a course of antibiotics
• Documented failure to thrive, i.e. flattening of weight curve crossing centiles, documented weight loss, e.g. > 5%, moderate or severe malnutrition (Weight-for-height Z score < − 2) in relation to previous measures
• Classic gibbus suggestive of spinal TB
• Depressed level of consciousness, new onset seizures or focal neurological signs suggestive of TB meningitis
• AFBs or caseating granulomas on microscopy (not confirmed by culture or Xpert to be TB)
• CXR suggestive of TB (concurrence between two blinded CXR reviewers, with conflicts resolved by third reviewer) despite a course of antibiotics
• CSF suggestive of TB (white cell count 10-500 cells per µl with a lymphocyte predominance, protein > 1 g/dL, glucose < 2.2 mmol/L)
• Pleural aspirate or ascitic tap with WBC counts, protein, and glucose levels suggestive of TB, consider ADA
• CT brain suggestive of CNS TB
  1. • Confirmed TB: positive M. tuberculosis + at least one of either A or B
  2. • Positive M. tuberculosis: (adapted from Graham et al. [57]): at least one positive culture (with confirmed M. tuberculosis speciation) or one positive WHO-endorsed NAAT (e.g. XpertMTB/RIF assay) from respiratory samples (expectorated/induced sputum or gastric aspirate) or other samples such as fine needle aspiration biopsy or other fluid or tissue samples
  3. • Probable TB: at least one of A and at least one of B
  4. • Possible TB: at least one of A or B (but not both) and a decision to treat
  5. • Not TB: the absence of clinical, radiological or laboratory evidence that meets any of the above criteria
  6. • TB infection: immunological evidence of infection with M. tuberculosis (TST/IGRA) plus classification as ‘Not TB’.
  7. • Indeterminate/unclassifiable TB status: documented results of the diagnostic evaluation (suspicious symptoms, chest radiograph, laboratory tests) are insufficient for the Endpoint Review Panel to reach determination
  8. • Death: mortality will be classified as death from any cause. TB deaths will be verified using available data (including death certificate, post mortem, hospital and other clinical information or other as available). The Endpoint Review Committee will review and determine the cause of death, if there are any deaths, in all children participating in the trial. Death occurring during a TB episode will be classified as TB death, unless there is clear evidence that the death is unrelated (e.g. motor vehicle accident)
  9. TB tuberculosis, AFBs acid-fast bacilli, CXR chest radiograph, ADA adenosine deaminase, CNS central nervous system, CSF cerebrospinal fluid, CT computed tomography, IGRA interferon-gamma release assay, TST tuberculin skin test, WBC white blood count, WHO World Health Organization, NAAT nucleic acid amplification test