Clinical trial NCT02729532 - References

Tuberculosis — Effect of Xpert MTB/RIF on Patient Outcomes

Citation(s)

•   Balcha TT, Sturegård E, Winqvist N, Skogmar S, Reepalu A, Jemal ZH, Tibesso G, Schön T, Björkman P
  Intensified tuberculosis case-finding in HIV-positive adults managed at Ethiopian health centers: diagnostic yield of Xpert MTB/RIF compared with smear microscopy and liquid culture. PLoS One. 2014 Jan 22;9(1):e85478. doi: 10.1371/journal.pone.0085478. eCollection 2014.
•   Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD
  Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
•   Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, Gler MT, Blakemore R, Worodria W, Gray C, Huang L, Caceres T, Mehdiyev R, Raymond L, Whitelaw A, Sagadevan K, Alexander H, Albert H, Cobelens F, Cox H, Alland D, Perkins MD
  Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet. 2011 Apr 30;377(9776):1495-505. doi: 10.1016/S0140-6736(11)60438-8. Epub 2011 Apr 18.
•   Boehme, C
  C. Oral Presentation, 20th Conference on Retroviruses and Opportunistic Infections. Georgia World Conference Centre, Atlanta, USA, March 3-6, 2013.
•   Botha E, Den Boon S, Verver S, Dunbar R, Lawrence KA, Bosman M, Enarson DA, Toms I, Beyers N
  Initial default from tuberculosis treatment: how often does it happen and what are the reasons? Int J Tuberc Lung Dis. 2008 Jul;12(7):820-3.
•   Chang K, Lu W, Wang J, Zhang K, Jia S, Li F, Deng S, Chen M
  Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. J Infect. 2012 Jun;64(6):580-8. doi: 10.1016/j.jinf.2012.02.012. Epub 2012 Feb 27.
•   Clouse K, Page-Shipp L, Dansey H, Moatlhodi B, Scott L, Bassett J, Stevens W, Sanne I, Van Rie A
  Implementation of Xpert MTB/RIF for routine point-of-care diagnosis of tuberculosis at the primary care level. S Afr Med J. 2012 Sep 7;102(10):805-7. doi: 10.7196/samj.5851.
•   Cohen T, Murray M, Wallengren K, Alvarez GG, Samuel EY, Wilson D
  The prevalence and drug sensitivity of tuberculosis among patients dying in hospital in KwaZulu-Natal, South Africa: a postmortem study. PLoS Med. 2010 Jun 22;7(6):e1000296. doi: 10.1371/journal.pmed.1000296.
•   Conwell DS, Mosher A, Khan A, Tapy J, Sandman L, Vernon A, Horsburgh CR Jr
  Factors associated with loss to follow-up in a large tuberculosis treatment trial (TBTC Study 22). Contemp Clin Trials. 2007 May;28(3):288-94. Epub 2006 Sep 28.
•   Dowdy DW, Davis JL, den Boon S, Walter ND, Katamba A, Cattamanchi A
  Population-level impact of same-day microscopy and Xpert MTB/RIF for tuberculosis diagnosis in Africa. PLoS One. 2013 Aug 12;8(8):e70485. doi: 10.1371/journal.pone.0070485. eCollection 2013.
•   Getahun H, Harrington M, O'Brien R, Nunn P
  Diagnosis of smear-negative pulmonary tuberculosis in people with HIV infection or AIDS in resource-constrained settings: informing urgent policy changes. Lancet. 2007 Jun 16;369(9578):2042-2049. doi: 10.1016/S0140-6736(07)60284-0. Review.
•   Global Health Workforce Statistics, World Health Organization, Geneva
  Accessed online at: http://www.who.int/hrh/statistics/hwfstats/ on November 24, 2013.
•   Global Laboratory Initiative
  Laboratory diagnosis of tuberculosis by sputum microscopy: The handbook. Geneva: Global Laboratory Initiative, 2013.
•   Hanrahan CF, Selibas K, Deery CB, Dansey H, Clouse K, Bassett J, Scott L, Stevens W, Sanne I, Van Rie A
  Time to treatment and patient outcomes among TB suspects screened by a single point-of-care xpert MTB/RIF at a primary care clinic in Johannesburg, South Africa. PLoS One. 2013 Jun 6;8(6):e65421. doi: 10.1371/journal.pone.0065421. Print 2013.
•   Henostroza G, Harris J, Siyambango M, et al
  High prevalence of tuberculosis among new HIV care enrolees in Zambia: urgent need for an enhanced screening approach. Oral presentation, 43rd World Conference on Lung Health. Kuala Lumpur Convention Centre, Kuala Lumpur, Malaysia. November 13 - 17, 2012.
•   Joffe MM, Rosenbaum PR
  Invited commentary: propensity scores. Am J Epidemiol. 1999 Aug 15;150(4):327-33. Review.
•   Kivihya-Ndugga LE, van Cleeff MR, Githui WA, Nganga LW, Kibuga DK, Odhiambo JA, Klatser PR
  A comprehensive comparison of Ziehl-Neelsen and fluorescence microscopy for the diagnosis of tuberculosis in a resource-poor urban setting. Int J Tuberc Lung Dis. 2003 Dec;7(12):1163-71.
•   Lawn SD, Ayles H, Egwaga S, Williams B, Mukadi YD, Santos Filho ED, Godfrey-Faussett P, Granich RM, Harries AD
  Potential utility of empirical tuberculosis treatment for HIV-infected patients with advanced immunodeficiency in high TB-HIV burden settings. Int J Tuberc Lung Dis. 2011 Mar;15(3):287-95.
•   Lawn SD, Brooks SV, Kranzer K, Nicol MP, Whitelaw A, Vogt M, Bekker LG, Wood R
  Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med. 2011 Jul;8(7):e1001067. doi: 10.1371/journal.pmed.1001067. Epub 2011 Jul 26.
•   Millen SJ, Uys PW, Hargrove J, van Helden PD, Williams BG
  The effect of diagnostic delays on the drop-out rate and the total delay to diagnosis of tuberculosis. PLoS One. 2008 Apr 9;3(4):e1933. doi: 10.1371/journal.pone.0001933.
•   Ministry of Health, Republic of Zambia
  Managing Tuberculosis in the HIV Setting in Zambia. Lusaka: Ministry of Health, 2014.
•   Moure R, Martín R, Alcaide F
  Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. J Clin Microbiol. 2012 Feb;50(2):513-5. doi: 10.1128/JCM.06467-11. Epub 2011 Dec 7.
•   Office of the U
  S. Global AIDS Coordinator. Scaling Up TB Prevention, Screening, Diagnosis and Care in Zambia: Implementing the WHO 3I's, Program Protocol. Lusaka: Centers for Disease Control and Prevention—Zambia, 2012.
•   Sreeramareddy CT, Panduru KV, Menten J, Van den Ende J
  Time delays in diagnosis of pulmonary tuberculosis: a systematic review of literature. BMC Infect Dis. 2009 Jun 11;9:91. doi: 10.1186/1471-2334-9-91. Review.
•   Steingart KR, Henry M, Ng V, Hopewell PC, Ramsay A, Cunningham J, Urbanczik R, Perkins M, Aziz MA, Pai M
  Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review. Lancet Infect Dis. 2006 Sep;6(9):570-81. Review. Erratum in: Lancet Infect Dis. 2006 Oct;6(10):628.
•   Steingart KR, Sohn H, Schiller I, Kloda LA, Boehme CC, Pai M, Dendukuri N
  Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD009593. doi: 10.1002/14651858.CD009593.pub2. Review. Update in: Cochrane Database Syst Rev. 2014;(1):CD009593.
•   Theron G, Peter J, Dowdy D, Langley I, Squire SB, Dheda K
  Do high rates of empirical treatment undermine the potential effect of new diagnostic tests for tuberculosis in high-burden settings? Lancet Infect Dis. 2014 Jun;14(6):527-32. doi: 10.1016/S1473-3099(13)70360-8. Epub 2014 Jan 15.
•   Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, Lesosky M, Bara W, Mungofa S, Pai M, Hoelscher M, Dowdy D, Pym A, Mwaba P, Mason P, Peter J, Dheda K; TB-NEAT team
  Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet. 2014 Feb 1;383(9915):424-35. doi: 10.1016/S0140-6736(13)62073-5. Epub 2013 Oct 28.
•   UNAIDS
  Global Report: UNAIDS report on the global AIDS epidemic 2013. Geneva: Joint United Nations Programme on HIV/AIDS, 2013.
•   Van Rie A, Page-Shipp L, Hanrahan CF, Schnippel K, Dansey H, Bassett J, Clouse K, Scott L, Stevens W, Sanne I
  Point-of-care Xpert® MTB/RIF for smear-negative tuberculosis suspects at a primary care clinic in South Africa. Int J Tuberc Lung Dis. 2013 Mar;17(3):368-72. doi: 10.5588/ijtld.12.0392.
•   Vassall A, van Kampen S, Sohn H, Michael JS, John KR, den Boon S, Davis JL, Whitelaw A, Nicol MP, Gler MT, Khaliqov A, Zamudio C, Perkins MD, Boehme CC, Cobelens F
  Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis. PLoS Med. 2011 Nov;8(11):e1001120. doi: 10.1371/journal.pmed.1001120. Epub 2011 Nov 8.
•   WHO
  Guidelines for intensified tuberculosis case-finding and isoniazid preventative therapy for people living with HIV in resource-constrained settings. Geneva: World Health Organization, 2011.
•   WHO
  Treatment of tuberculosis guidelines, 4th edition. Geneva: World Health Organization, 2010.
•   WHO/TDR/FIND
  Diagnostics for tuberculosis: Global demand and market potential. Geneva: World Health Organization, 2006.
•   World Health Organization
  (2013). Global tuberculosis report 2013. Geneva: WHO.
•   Yoon C, Cattamanchi A, Davis JL, Worodria W, den Boon S, Kalema N, Katagira W, Kaswabuli S, Miller C, Andama A, Albert H, Nabeta P, Gray C, Ayakaka I, Huang L
  Impact of Xpert MTB/RIF testing on tuberculosis management and outcomes in hospitalized patients in Uganda. PLoS One. 2012;7(11):e48599. doi: 10.1371/journal.pone.0048599. Epub 2012 Nov 6.
•   Zou G
  A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6.

Z 31411 - The Effect of Xpert MTB/RIF on Patient Health Outcomes and Empirical TB Treatment Among Persons Living With HIV/AIDS: A Parallel-Group Prospective Cohort Study Under Real-World Conditions in Lusaka, Zambia

Details for clinical trial NCT02729532