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. Author manuscript; available in PMC: 2011 Mar 9.
Published in final edited form as: N Engl J Med. 2010 Sep 9;363(11):1005–1015. doi: 10.1056/NEJMoa0907847

Table 1.

Demographic and Clinical Characteristics of the Patients, Diagnosis Group at Enrollment, and Distribution in Final Diagnostic Category.*

Variable Lima, Peru (N=341) Baku, Azerbaijan (N = 353) Cape Town, South Africa (N = 380) Durban, South Africa (N = 346) Mumbai, India (N = 310) All Patients (N = 1730)
Demographic or clinical characteristic
Median age (range) — yr 31 (18–79) 37 (20–69) 36 (18–80) 32 (18–68) 30 (17–88) 34 (17–88)
Female sex — no./total no. (%) 138/319 (43.3) 0/251 119/349 (34.1) 186/313 (59.4) 90/230 (39.1) 533/1462 (36.5)
HIV infection — no./total no. (%) 3/179 (1.7) 9/193 (4.7) 159/209 (76.1) 217/304 (71.4) 4/91 (4.4) 392/976 (40.2)
History of tuberculosis — no./total no. (%) 75/316 (23.7) 137/251 (54.6) 148/344 (43.0) 138/306 (45.1) 173/230 (75.2) 671/1447 (46.4)
Diagnosis group at enrollment
Suspicion of pulmonary tuberculosis — no./total no. (%) 293/341 (85.9) 131/353 (37.1) 223/380 (58.7) 272/346 (78.6) 91/310 (29.4) 1010/1730 (58.4)
Suspicion of multidrug-resistant tuberculosis not receiving therapy — no./total no. (%) 41/341 (12.0) 149/353 (42.2) 136/380 (35.8) 59/346 (17.1) 60/310 (19.4) 445/1730 (25.7)
Suspicion of multidrug-resistant tuberculosis receiving therapy — no./total no. (%) 7/341 (2.1) 73/353 (20.7) 21/380 (5.5) 15/346 (4.3) 159/310 (51.3) 275/1730 (15.9)
Distribution in final diagnostic category
Smear- and culture-positive tuberculosis — no./total no. (%) 199/341 (58.4) 80/353 (22.7) 96/380 (25.3) 30/346 (8.7) 162/310 (52.3) 567/1730 (32.8)
Smear-negative and culture-positive tuberculosis — no./total no. (%) 12/341 (3.5) 69/353 (19.5) 52/380 (13.7) 15/346 (4.3) 26/310 (8.4) 174/1730 (10.1)
Clinical tuberculosis — no./total no. (%) 6/341 (1.8) 32/353 (9.1) 12/380 (3.2) 49/346 (14.2) 6/310 (1.9) 105/1730 (6.1)
No tuberculosis — no./total no. (%) 102/341 (29.9) 70/353 (19.8) 189/380 (49.7) 219/346 (63.3) 36/310 (11.6) 616/1730 (35.6)
Indeterminate — no./total no. (%) 22/341 (6.5) 102/353 (28.9) 31/380 (8.2) 33/346 (9.5) 80/310 (25.8) 268/1730 (15.5)
    Culture-negative disease with suspected multidrug resistance receiving therapy 2/22 (9.1) 51/102 (50.0) 3/31 (9.7) 10/33 (30.3) 49/80 (61.3) 115/268 (42.9)
    Contamination of ≥3 of 4 cultures 0/22 28/102 (27.5) 0/31 0/33 0/80 28/268 (10.4)
    Single culture positive with >28 days (MGIT) or <20 colonies (LJ) 0/22 0/102 3/31 (9.7) 2/33 (6.1) 2/80 (2.5) 7/268 (2.6)
    Smear-positive, culture-negative tuberculosis 14/22 (63.6) 5/102 (4.9) 4/31 (12.9) 12/33 (36.4) 4/80 (5.0) 39/268 (14.6)
    Nontuberculous mycobacteria only 2/22 (9.1) 4/102 (3.9) 1/31 (3.2) 2/33 (6.1) 14/80 (17.5) 23/268 (8.6)
    Discrepant phenotypic drug-susceptibility testing 2/22 (9.1) 5/102 (4.9) 2/31 (6.5) 0/33 1/80 (1.3) 10/268 (3.7)
    Death or loss to follow-up 2/22 (9.1) 9/102 (8.8) 18/31 (58.1) 7/33 (21.2) 10/80 (12.5) 46/268 (17.2)
*

HIV denotes human immunodeficiency virus, LJ Löwenstein–Jensen, and MGIT mycobacteria growth indicator tube.

In Azerbaijan, there was a delay of up to 8 days between sputum collection and processing because of air transport to the laboratory in Germany, which resulted in an overall culture contamination rate of 13.9%, as compared with less than 2% for other sites.