A randomized controlled trial of standard versus intensified tuberculosis diagnostics on treatment decisions by physicians in Northern Tanzania

BMC Infectious Diseases

Carol D Hamilton⁹  John A Bartlett²  John A Crump²  Jason E Stout⁶  Shein-Chung Chow⁵  John F Shao^1,10  Werner Schimana⁷  Coleen K Cunningham⁶  Nathan M Thielman¹  Gibson S Kibiki^1,10  Anne B Morrissey⁶  Levina J Msuya^1,10  Venance P Maro^1,10  Alison C Tribble²  Kathryn E Lancaster³  Susan C Morpeth⁴  Boniface N Njau⁸  Elizabeth A Reddy⁸ 

[1]Duke Global Health Institute, Duke University, Durham, NC, USA

[2]Children’s Hospital of Philadelphia, Philadelphia, PA, USA

[3]Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA

[4]KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya

[5]Duke Clinical Research Institute, Duke University, Durham, NC, USA

[6]Duke University Medical Center, Durham, NC, USA

[7]Elizabeth Glaser Pediatric AIDS Foundation Tanzania, Dar Es Salaam, Tanzania

[8]Kilimanjaro Christian Medical Centre, Box 3010, CCFCC Duke Projects, Moshi, Tanzania

[9]FHI 360, Durham, NC, USA

[10]Kilimanjaro Christian Medical University College, Moshi, Tanzania

关键词: Child;    adult;    HIV;    Sputum/microbiology;    Health resources;    Diagnosis;    Mycobacterium tuberculosis;   

Others  :  1134547
DOI  :  10.1186/1471-2334-14-89

 received in 2013-02-05, accepted in 2014-02-13,  发布年份 2014

【 摘 要 】

Background

Routine tuberculosis culture remains unavailable in many high-burden areas, including Tanzania. This study sought to determine the impact of providing mycobacterial culture results over standard of care [unconcentrated acid-fast (AFB) smears] on management of persons with suspected tuberculosis.

Methods

Adults and children with suspected tuberculosis were randomized to standard (direct AFB smear only) or intensified (concentrated AFB smear and tuberculosis culture) diagnostics and followed for 8 weeks. The primary endpoint was appropriate treatment (i.e. antituberculosis therapy for those with tuberculosis, no antituberculous therapy for those without tuberculosis).

Results

Seventy participants were randomized to standard (n = 37, 53%) or intensive (n = 33, 47%) diagnostics. At 8 weeks, 100% (n = 22) of participants in follow up randomized to intensive diagnostics were receiving appropriate care, vs. 22 (88%) of 25 participants randomized to standard diagnostics (p = 0.14). Overall, 18 (26%) participants died; antituberculosis therapy was associated with lower mortality (9% who received antiuberculosis treatment died vs. 26% who did not, p = 0.04).

Conclusions

Under field conditions in a high burden setting, the impact of intensified diagnostics was blunted by high early mortality. Enhanced availability of rapid diagnostics must be linked to earlier access to care for outcomes to improve.

【 授权许可】

   
2014 Reddy et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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