Intervals and mean time to detection are given in the bottom lines. Nineteen studies were included and surveyed for the number of specimens included and the type of liquid (MGIT, BACTEC) or solid culture medium used. support control efforts and selection of proper therapy (1,2). Article Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. states, 8% of cases were resistant to isoniazid (INH) and 2% were Phillips PP, Dooley KE, Gillespie SH, et al. Food and Drug Administration. During the trial, sputum samples were taken for smear and culture (LJ and MGIT in parallel) weekly to 8 weeks during treatment, monthly thereafter to 6 months and 3-monthly thereafter to 18 months from randomisation. Second, data were tuberculosis (3). addition, the referral of AFB-positive culture growth to another Good RC. questionnaire. A total of 1931 patients were randomised across sites in Africa and Asia and followed for 18 months from randomisation. Non-TB mycobacteria (NTM) were more often identified in MGIT than on LJ, 318 (2.6%) and 88 (0.7%) respectively in all samples, but only in 35 (0.3%) in both samples. In order to further explore which of the parameters to which clinicians had access in the clinic might be associated with MGIT isolated positives, we conducted analyses restricted only to positive culture results at or after week 33. Traditionally, solid culture media for mycobacteria are kept for up to 8 weeks before a negative result is reported to the physician. DISCLAIMER | 1) was responsible for the cultures of only 4.6% of all patients in the trial, yet it reported 8 (33%) of the 24 patients with a protocol-defined favourable outcome with two or more positive MGIT cultures in post-treatment follow-up. LJ was used for the definition of the primary endpoint in the REMoxTB trial, but every culture was also inoculated in parallel into the MGIT system. Only 58% of MGIT positive results that are also smear negative are isolated positives, and only 69% of MGIT positive results that are also LJ negative are isolated positives. Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. M. tuberculosis bacilli are slow-growing mycobacteria which means that in primary isolation they hardly show any visible growth during the first week of culture. This result is not surprising given the known performance characteristics of the MGIT system, which is associated with a lower limit of detection as well as a more rapid time to positivity [17,18,19]. The trial showed that the two 4 month moxifloxacin regimens were safe but did not have non-inferior efficacy compared to the 6 month control in patients with uncomplicated, smear-positive tuberculosis [4]. High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis: a multi-arm, multi-stage randomised controlled trial. PT programs) for laboratories that perform AFB smears only, Treatment Action Group, Frick M. 2015 report on tuberculosis research funding trends, 2005–2014: a decade of data. There was clear evidence of clustering of isolated positive in some patients even after adjusting for study laboratory (random effects variance 1.23 (standard error 0.373), p < 0.0001), meaning that the number of patients with two or more positive MGIT cultures in post-treatment follow-up was too high to be explained by cross-contamination only. In Switzerland, it is common practice to comply with these protocols, and no reports to the clinicians are currently generated prior to 6 to 8 weeks. Irrespective of smear results, the mean time to detection (TTD) in the MGIT broth was 15.3 days for all mycobacteria, 17.1 days for the M. tuberculosis complex, and 12.6 days for NTM, while one MGIT result remained negative. 30333, U.S.A. Typically, subsequent cultures are negative, there is no evidence of symptomatic recurrence and these patients do not need to be retreated. 54% of laboratories performing primary cultures for M. tuberculosis At least one state (i.e., RR-11). Jindani A, Harrison TS, Nunn AJ, et al. However, it perfectly reflects the low incidence of tuberculosis (7.1 per 100,000 inhabitants [5]) and possibly also of NTM disease in Switzerland. Tuberculosis kills more people than any other infectious disease, and new regimens are essential. unavailable to determine whether laboratories that refer culture 2. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. © 2020 BioMed Central Ltd unless otherwise stated. CAS and the emergence of multidrug-resistant Mycobacterium tuberculosis Acid-fast bacilli (AFB) were detectable in 31 clinical specimens by smear, culture, and optionally, direct molecular tests. the states of New Jersey, New York, and Wisconsin; and the in each of the four categories ranges from a minimum that All patients provided written or witnessed oral informed consent. CDC. Mycobacterium tuberculosis grew in 13 specimens, Mycobacterium bovis grew in one specimen, and nontuberculous mycobacteria (NTM) grew in 10 specimens (Mycobacterium avium, n = 1; Mycobacterium chelonae, n = 3; Mycobacterium fortuitum, n = 1; Mycobacterium gordonae, n = 1; Mycobacterium malmoense, n = 1; Mycobacterium peregrinum, n = 1; Mycobacterium simiae, n = 2). The likelihood ratio test was used to compare models. NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. statement and In addition to economic considerations, negative interim reports may help the clinician evaluate alternative differential diagnoses much earlier. organism identification and drug-susceptibility testing, 699 (32%) As expected, there were slightly more positive cultures and more isolated positive cultures in MGIT than on LJ, although there was agreement between LJ and MGIT in the majority of sputum samples where contamination did not occur in either medium. Laboratories are sorted by percentage of isolated positives on MGIT and labelled A to L. Error bars show 95% exact binomial confidence intervals. Positive cultures in MGIT were more likely to be smear positive or LJ positive in patients with both favourable and unfavourable outcomes, yet isolated positive cultures in MGIT in patients with a favourable outcome were not associated with TB symptoms reported within 7 days of sputum collection, while positive culture results in patients with an unfavourable outcome were strongly associated with TB symptoms. tuberculosis but refer all AFB-positive culture isolates for Div of Guidance for Industry. Springer Nature. Seven specimens were excluded because either they originated from tuberculosis (TB) patients under treatment (smear positive/culture negative) or there was a high clinical suspicion of tuberculosis (culture negative/confirmed by strand displacement amplification [SDA; BD]) (3). identification, and 259-314 for those that perform primary culture, limitations. First, data were unavailable about the proportion of Article isolates but refer isolates for drug-susceptibility testing; and 4) culture), identification, and drug-susceptibility testing for M. Quality-control in tuberculosis bacteriology. thereby delaying organism identification to confirm diagnosis. MRC Clinical Trials Unit at UCL, London, UK, Patrick P. J. Phillips, Andrew J. Nunn & Angela M. Crook, Division of Pulmonary & Critical Care Medicine, University of California, San Francisco, San Francisco, USA, Global Alliance for TB Drug Development, New York, NY, USA, Centre for Clinical Microbiology, UCL, London, UK, Timothy D. McHugh, Robert Hunt & Anna Bateson, School of Medicine, University of St Andrews, St Andrews, UK, Division of Biostatistics, University of California, San Francisco, San Francisco, USA, You can also search for this author in 2014;371(17):1599–608. 2015;385(9979):1738–47. Lu D, Heeren B, Dunne WM. We tested the hypothesis that MGIT post-treatment positive results in patients with a favourable outcome are not indicative of relapse. LETTER. Certain patients had repeated positive MGIT cultures that did not meet the definition of a relapse. methods. performed primary culture, identification, and drug-susceptibility Dawson R, Diacon AH, Everitt D, et al. However, Table 3 also shows that none of these factors can be used to definitively identify an isolated positive (associated with a favourable outcome). The exclusive use of solid-medium culture methods delays The laboratory diagnosis of tuberculosis usually relies on culture-based isolation of the causative Mycobacterium tuberculosis bacteria. J Clin Microbiol 1995;33:407-12. https://www.ucl.ac.uk/infection-immunity/research/res_ccm/ccm_accor/ccm_remox, http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/, https://doi.org/10.1186/s12916-017-0955-9, Making a difference in the management of tuberculosis: REMoxTB series. Cross-contamination is a threat to the integrity of the results of a clinical trial and a risk to patients, since they may unnecessarily be given extended treatment that may include more toxic regimens. organism identification and drug-susceptibility testing, 568 (29%) Furthermore, patients with missing or contaminated LJ results at the end of follow-up were encouraged to return for follow-up visits to provide sputum for culture, and therefore there are fewer patients with missing results on LJ than on MGIT at the end of follow-up. Because of this, there are different types depending on … A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens. Pfaller MA, Tenover FC, Yolken RH, eds. specimens; the laboratories subsequently report methods and test CAS testing. Culture methodology is critical to the primary trial outcome. Types of Culture Media for growing Mycobacterium tuberculosis. It emphasises the importance of effective medical monitoring after treatment ends and consideration of clinical signs and symptoms for determining treatment failure and relapse. Even though it is well documented that liquid media detect mycobacteria much earlier, most incubation protocols still require a maximum of 6 weeks (2). This laboratory (A in Fig. It is thought that at least a proportion of isolated positives are derived from pulmonary lesions [8, 10], but we found that neither cavitation at baseline nor any other baseline characteristic was associated with an increased incidence of isolated positive on MGIT, after adjusting for site laboratory. These categories were laboratories that N Engl J Med. Among patients who had protocol-defined favourable outcomes, there was clear evidence that the incidence of isolated positives on MGIT differed by study laboratory (p < 0.0001) where in one laboratory, 21.9% of all post-treatment follow-up MGIT cultures in patients who were deemed to have favourable outcomes were positive (Fig. Phillips PP, Mendel CM, Burger DA, et al. In addition, a survey of programs, a 1992 survey of 749 laboratories that performed primary 2017;17(1):39–49. On Middlebrook agar, the mean TTD was 19.5 days for all mycobacteria, 23.7 days for the M. tuberculosis complex, and 12.3 days for NTM, while 5 cultures remained negative (Table 1). However, given the large number of isolated post treatment positives in addition to bacteriological relapses, the cost of whole genome sequencing would be prohibitive. Of these, 1166
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