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Phase 4 N=34,758 Randomized Diagnostic

Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil

Tuberculosis

Enrolled (actual)
34,758
Serious AEs
Results posted
Mar 2014
Primary outcome: Primary: Notification Rate Ratio — 48.7; 30.5 notifications/100,000 persons/year — p=<0.01

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Xpert MTB/Rif (Other); Smear microscopy (Other)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Ataulpho de Paiva Foundation
Primary completion
Oct 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Notification Rate Ratio
48.7; 30.5 <0.01 sig
PRIMARY
Costs Per Detected Case
714.95; 799.02
SECONDARY
NRR of Non-laboratory Tested TB (Cluster-averaged).
35.8; 36.9 0.923
SECONDARY
NRR of Negative-laboratory TB (Cluster-averaged).
7.3; 12.1 0.004 sig

Summary

Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat TB. The test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. The aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.

Eligibility Criteria

Inclusion Criteria

laboratories -and not subjects - will be randomized. All laboratories will start doing smears, when indicated by randomization, they will switch to Xpert MTB/Rif. There are no inclusion or exclusion criteria for the labs. Sputum specimens from non-diagnostic (follow up) patients, second samples for diagnostic tests, insufficient volume/visible blood specimens will be excluded from the Xpert testing.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01363765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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