Trial Outcomes & Findings for Prevention of Tuberculosis in Prisons (NCT NCT03028129)
NCT ID: NCT03028129
Last Updated: 2019-10-25
Results Overview
Number of participants who had a Quantiferon TB Gold Plus (QIAGEN®) score greater than or equal to 0.35 international units per milliliter, at the time of the premature exclusion visit, on all participants in the group.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
467 participants
Primary outcome timeframe
up to 6 months
Results posted on
2019-10-25
Participant Flow
Eligible participants were interviewed for eligibility criteria (age, race, alcohol use, comorbidities) and laboratory tests (HIV, hepatitis B and C, liver enzymes, interferon gamma dosing for tuberculosis antigens and active tuberculosis).
Study was discontinued at ninth month after interim analysis and showed efficacy in intervention group less than 2.5%
Participant milestones
| Measure |
Treatment
Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
|
Control
Each subject received two weekly supervised oral doses of placebo, without the active ingredient, similar in size, weight, color, taste and odor.
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
209
|
|
Overall Study
COMPLETED
|
132
|
122
|
|
Overall Study
NOT COMPLETED
|
126
|
87
|
Reasons for withdrawal
| Measure |
Treatment
Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
|
Control
Each subject received two weekly supervised oral doses of placebo, without the active ingredient, similar in size, weight, color, taste and odor.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
2
|
|
Overall Study
Lost to Follow-up
|
50
|
38
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
62
|
45
|
Baseline Characteristics
Prevention of Tuberculosis in Prisons
Baseline characteristics by cohort
| Measure |
Treatment
n=258 Participants
Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
|
Control
n=209 Participants
Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
|
Total
n=467 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
29.0 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
29.1 years
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=99 Participants
|
209 Participants
n=107 Participants
|
467 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
105 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
258 participants
n=99 Participants
|
209 participants
n=107 Participants
|
467 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: All participants who received at least one dose of isoniazid or placebo and who had blood sample collected to QFT examination at premature exclusion visit.
Number of participants who had a Quantiferon TB Gold Plus (QIAGEN®) score greater than or equal to 0.35 international units per milliliter, at the time of the premature exclusion visit, on all participants in the group.
Outcome measures
| Measure |
Treatment
n=132 Participants
Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
|
Control
n=122 Participants
Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
|
|---|---|---|
|
Quantiferon TB Gold Plus (QIAGEN®) Conversion at the Premature Exclusion Visit.
|
49 participants
|
77 participants
|
Adverse Events
Treatment
Serious events: 1 serious events
Other events: 190 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=258 participants at risk
Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
|
Control
n=209 participants at risk
Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
|
|---|---|---|
|
Hepatobiliary disorders
Elevated SGOT
|
0.39%
1/258 • Number of events 1 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
0.48%
1/209 • Number of events 1 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
Other adverse events
| Measure |
Treatment
n=258 participants at risk
Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.
|
Control
n=209 participants at risk
Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
21/258 • Number of events 21 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
11.5%
24/209 • Number of events 24 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
Nervous system disorders
Dizziness
|
10.5%
27/258 • Number of events 27 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
3.8%
8/209 • Number of events 8 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
Gastrointestinal disorders
Gastric pain
|
10.5%
27/258 • Number of events 27 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
7.2%
15/209 • Number of events 15 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
Nervous system disorders
Headache
|
11.6%
30/258 • Number of events 30 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
7.2%
15/209 • Number of events 15 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
General disorders
Malaise
|
11.2%
29/258 • Number of events 29 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
3.3%
7/209 • Number of events 7 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
Gastrointestinal disorders
Nausea
|
7.8%
20/258 • Number of events 20 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
1.9%
4/209 • Number of events 4 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
Psychiatric disorders
Somnolence
|
7.8%
20/258 • Number of events 20 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
4.3%
9/209 • Number of events 9 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
3.5%
9/258 • Number of events 9 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
5.7%
12/209 • Number of events 12 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
|
Infections and infestations
Flu syndrome
|
2.7%
7/258 • Number of events 7 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
7.2%
15/209 • Number of events 15 • 9 months
On the intervention days, all participants were asked about the presence of any unusual signs and / or symptoms. Data were recorded in a log containing start and end date, event description, degree and intervention performed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place