Trial Outcomes & Findings for Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil (NCT NCT01363765)
NCT ID: NCT01363765
Last Updated: 2014-03-12
Results Overview
Proportion of additional bacteriologically confirmed notified TB cases during intervention period compared to the observation period Patients notified who had a positive test result. The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.
COMPLETED
PHASE4
34758 participants
October 2012 (up to 2 years)
2014-03-12
Participant Flow
From Feb 4 to Oct 4 2012, all 11 primary care laboratories in Rio de Janeiro and 3 labs covering 70% of PTB diagnosis in Manaus participated. Over the same period, 4,660 patients were notified with PTB to SINAN (disease information database). Of these, 2,745 (59%) could be linked to test results in GAL (lab information system).
Samples (and not patients) were included if it was a first diagnostic sample in the intervention arm. Follow up (non diagnostic) samples were excluded for both arms, as were inadequate samples (insufficient material, blood stained-specimens) in the intervention group.
Participant milestones
| Measure |
Xpert MTB/Rif
Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
|
Sputum Smear
Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
|
|---|---|---|
|
Overall Study
STARTED
|
18322
|
16436
|
|
Overall Study
COMPLETED
|
12522
|
11705
|
|
Overall Study
NOT COMPLETED
|
5800
|
4731
|
Reasons for withdrawal
| Measure |
Xpert MTB/Rif
Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
|
Sputum Smear
Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
|
|---|---|---|
|
Overall Study
non-diagnostic
|
2621
|
1124
|
|
Overall Study
duplicate records
|
736
|
3177
|
|
Overall Study
non-resident
|
156
|
76
|
|
Overall Study
age not recorded (used for cross-linkage
|
117
|
354
|
|
Overall Study
smear during intervention
|
2170
|
0
|
Baseline Characteristics
Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil
Baseline characteristics by cohort
| Measure |
Xpert MTB/Rif
n=2610 Participants
One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
|
Sputum Smear
n=2050 Participants
Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
|
Total
n=4660 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 15 and 39 years
|
1395 participants
n=5 Participants
|
1068 participants
n=7 Participants
|
2463 participants
n=5 Participants
|
|
Age, Customized
Between 40 and 59 years
|
835 participants
n=5 Participants
|
682 participants
n=7 Participants
|
1517 participants
n=5 Participants
|
|
Age, Customized
>=60 years
|
324 participants
n=5 Participants
|
244 participants
n=7 Participants
|
568 participants
n=5 Participants
|
|
Age, Customized
<=14 years
|
56 participants
n=5 Participants
|
56 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
928 Participants
n=5 Participants
|
736 Participants
n=7 Participants
|
1664 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1682 Participants
n=5 Participants
|
1314 Participants
n=7 Participants
|
2996 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
2610 participants
n=5 Participants
|
2050 participants
n=7 Participants
|
4660 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: October 2012 (up to 2 years)Population: Only patients found both in laboratory and in the notification databases were included since this is an outcome based on notification rates. Population growth during time was estimated. NR per 100,000 population
Proportion of additional bacteriologically confirmed notified TB cases during intervention period compared to the observation period Patients notified who had a positive test result. The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.
Outcome measures
| Measure |
Xpert MTB/Rif
n=1385 Participants
One sample of sputum specimens arriving during intervention period was submitted to this technology
|
Sputum Smear
n=831 Participants
Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
|
|---|---|---|
|
Notification Rate Ratio
|
48.7 notifications/100,000 persons/year
Interval 41.5 to 55.8
|
30.5 notifications/100,000 persons/year
Interval 24.9 to 36.1
|
PRIMARY outcome
Timeframe: October 2012 (up to 2 years)Costs per detected case were analyzed using a decision tree model from the national health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated as (costs with Xpert - costs with smears)/(cases detected with Xpert - cases detected with smears). Negative ICERs mean cost saving.
Outcome measures
| Measure |
Xpert MTB/Rif
n=12522 Participants
One sample of sputum specimens arriving during intervention period was submitted to this technology
|
Sputum Smear
n=11705 Participants
Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
|
|---|---|---|
|
Costs Per Detected Case
|
714.95 American dollars
|
799.02 American dollars
|
SECONDARY outcome
Timeframe: October 2012 (up to 2 years)Population: The result is the notification rate ratio
The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section. Numbers are participants in the notification database who were not in the lab (all tests done) database; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group. Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test.
Outcome measures
| Measure |
Xpert MTB/Rif
n=1009 Participants
One sample of sputum specimens arriving during intervention period was submitted to this technology
|
Sputum Smear
n=906 Participants
Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
|
|---|---|---|
|
NRR of Non-laboratory Tested TB (Cluster-averaged).
|
35.8 notifications/100,000 persons/year
Interval 27.6 to 43.9
|
36.9 notifications/100,000 persons/year
Interval 26.8 to 47.1
|
SECONDARY outcome
Timeframe: October 2012 (up to 2 years)The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section. Numbers are driven from linkage between lab (all tests done) and notification databases; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group. Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test.
Outcome measures
| Measure |
Xpert MTB/Rif
n=216 Participants
One sample of sputum specimens arriving during intervention period was submitted to this technology
|
Sputum Smear
n=313 Participants
Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
|
|---|---|---|
|
NRR of Negative-laboratory TB (Cluster-averaged).
|
7.3 notifications/100,000 persons/year
Interval 2.1 to 12.5
|
12.1 notifications/100,000 persons/year
Interval 6.1 to 18.0
|
Adverse Events
Xpert MTB/Rif
Sputum Smear
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place